New French rubber food contact regulations come into force
The decree entered into force on July 1, 2021 and repealed the decree of November 9, 1994. If it is put on the market before the new law takes effect, the food contact rubber materials and articles in accordance with the old law can continue to be sold until the inventory is exhausted. The new act is updated as follows:
Scope of application update
The decree applies to natural rubber and vulcanized thermoplastic elastomers, but not to silicone elastomers.
Material specification update
• update the list of authorized substances used in the manufacture of food contact rubber products and rubber pacifiers for infants and young children.
• update the limits and parameters of authorized substances, including specific migration limits (SML).
Update of finished product requirements
• update some rules for verifying the conformity of rubber materials and products, such as adding secondary aromatic amine migration, hexamethylene tetramine migration, heavy metal migration and content requirements; VOM increases allowable tolerance, etc.
• update the comprehensive migration restriction requirements and express them in one of the following two ways:
≤10mg/dm ²， Applicable to all items; Infant pacifier; Gaskets, valves and valve elements with unknown or unspecified surface to volume ratio in contact with food.
≤ 60mg / kg, applicable to infant food contact materials and articles; nipple; Gaskets, valves and valve elements with known or specified surface to volume ratio in contact with food.
| Restriction | Requirement(s) |
| Volatile organic matter (VOM) | ≤ 0.5 % m/m ± 0.1 % m/m |
| Overall migration | < 10 mg/dm2 for: 1.soothers for infants and young children; 2.seals, valves and valve elements of which the actual ratio between the surface in contact with food and the volume is not known or specified; 3.articles that do not fall into any categories specified in 1) and 2). < 10 mg/dm2 of the total contact surface area of the closing device and of the recipient closed by capsules, seals, stoppers and other closing devices; < 60 mg/kg for: 1.food contact materials and articles for infants and young children; 2.baby bottle teats; 3.seals, valves and valve elements of which the actual ratio between the surface in contact with food and the volume is known or specified. |
N-Nitrosamine N-Nitrosatable substances | Products other than baby bottle teats and soothers for infants and young children: 1.N-Nitrosamines: SML ≤ 1 μg/dm2; 2.N-Nitrosatable substances: SML ≤ 10 μg/dm2 Baby bottle teats and soothers for infants and young children (in accordance with the conditions and criteria laid down in Annex IV): 1.≤ 0.01 mg of the total N-nitrosamines released per kilogram (of the parts of the teat or soother made of elastomer or rubber); 2.≤ 0.1 mg of the total N-nitrosatable substances per kilogram (of the parts of the teat or soother made of elastomer or rubber). |
| Primary aromatic amine and secondary aromatic amine | Primary aromatic amines: Not detectable (SML(T) ≤ 0.01 mg/kg) Primary and secondary aromatic amines: SML(T) ≤ 1 mg/kg |
| Formaldehyde and Hexamethylenetetramine | Formaldehyde: SML ≤ 3 mg/kg Formaldehyde and Hexamethylenetetramine: SML(T) ≤ 15 mg/kg |
| Peroxide | Peroxide-cured materials and finished articles that are ready for use must not give a positive reaction to peroxides according to the method of the European Pharmacopoeia. |
| Heavy metals | Barium: SML(T) ≤ 1.2 mg/kg Copper: SML(T) ≤ 4 mg/kg Aluminum: SML(T) ≤ 1 mg/kg Zinc: SML(T) ≤ 5 mg/kg The residual content (Qm) of the following impurities in the finished products must not exceed 1 mg/kg: lead, cadmium, antimony, mercury and arsenic. |