France – Replacement of Rubber Food Contact Regulation Approved
Vol. 1182 | 20 Aug 2020
The Ministry of Economy, Finance and Recovery of France has published Order of 5 August 2020, on rubber food contact materials and articles and pacifiers for infants and young children, which shall replace and repeal Order of 9 November 1994, on 1 July 2021.
The Order shall apply to natural rubber and vulcanized thermoplastic elastomers, but not silicone elastomers. Its important provisions are summarized as follows:
- Synthetic rubber materials shall only be made of substances listed in Annex I and Annex VIII of the Order. Annex VIII substances can only be used until 1 July 2025, unless an assessment dossier is submitted before the date and authorization of use is granted.
- Natural rubber shall meet these specifications:
a. It shall have little colour and be “non-smoked”.
b. It shall not contain p-nitrophenol, boric acid or pentachlorophenol and its sodium salts.
c. Hydroxylamine shall not be detected in finished products.
d. Products containing natural rubber latex shall be indicated.
- Pigments and some other additives specified in the Order can be added during the development of rubber materials and articles.
Requirements for finished products
Volatile organic free matter
≤ 0.5 % m/m ± 0.1 % m/m (tested according to Annex VI of the Order)
(a) < 10 mg/dm2 of surface of article
N-nitrosamines and N-nitrosatable substances
Specific migration limit (shall not apply to bottle teats and pacifiers made of elastomer or rubber):
Release of substances (for bottle teats and pacifiers made of elastomer or rubber only):
Primary aromatic amines
Specific migration limit: Not detectable
Primary and secondary aromatic amines
Specific migration limit: ≤ 1 mg/kg
(a) Specific migration limit of formaldehyde: ≤ 3 mg/kg
Ready-to-use materials and finished articles vulcanized with peroxides shall not give a positive reaction to peroxides (tested according to the European Pharmacopoeia method)
Specific migration limit:
Residual content of impurities (lead, cadmium, antimony, mercury and arsenic) in finished products ≤ 1 mg/kg
Appropriate documentation to demonstrate the compliance with the requirements of the Order shall be made available to responsible officials upon request. A written Declaration of Conformity shall also be prepared, according to Annex V of the Order.
- Rubber food contact articles and pacifiers which are placed on the market for the first time before 1 July 2021, can be marketed until stocks are exhausted.
- Products made of constituents listed in Annex VIII, for which no authorization of use after 1 July 2025, has been granted, can be marketed until stocks are exhausted.
For additional information please contact:
+852 3760 6361