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:
① Clarification to the definition of rubber covers vulcanized thermoplastic elastomers, but not silicone elastomer;
② 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;
③ Update the restriction and specifications of certain authorized substances, including specific migration limit(SML);
④ Update certain rules for verifying the conformity of rubber materials and articles, please see below table for more details.
⑤ 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