France – Replacement of Rubber Food Contact Regulation Approved

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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:

Material specifications

  1. 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.
  2. 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.
  3. 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)

Overall migration

(a) < 10 mg/dm2 of surface of article

  • for pacifiers for infants and young children
  • for seals, valves and valve elements of which the actual ratio between surface area in contact with food and volume is not known or specified
  • by default, for articles that do not fall into any category specified in (a) or (b)
(b) < 10 mg/dm2 of total contact surface 
  • for sealing articles and sealed containers closed by capsules, seals, stoppers and other sealing articles
(c) < 60 mg/kg of food or food simulant
  • for materials and articles intended to come into contact with food for infants and young children
  • for bottle teats
  • for seals, valves and valve elements of which the actual ratio between the food contact surface and the volume is known and specified

N-nitrosamines and N-nitrosatable substances

Specific migration limit (shall not apply to bottle teats and pacifiers made of elastomer or rubber):

  • N-nitrosamines: ≤ 1 μg/dm2
  • N-nitrosatable substances: ≤ 10 μg/dm2

Release of substances (for bottle teats and pacifiers made of elastomer or rubber only):

  • N-nitrosamines: ≤ 0.01 mg/kg of component part
  • N-nitrosatable substances: ≤ 0.1 mg/kg of component part
 

Primary aromatic amines

Specific migration limit: Not detectable
(Detection limit of sum of primary aromatic amines released: ≤ 0.01 mg/kg)

Primary and secondary aromatic amines

Specific migration limit: ≤ 1 mg/kg

Formaldehyde

(a) Specific migration limit of formaldehyde: ≤ 3 mg/kg
(b) Sum of migration of hexamethylenetetramine and formaldehyde: ≤ 15 mg/kg

Peroxides

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)

Heavy metals

Specific migration limit:

  • Barium: ≤ 1.2 mg/kg
  • Copper: ≤ 4 mg/kg
  • Aluminium: ≤ 1 mg/kg
  • Zinc: ≤ 5 mg/kg

Residual content of impurities (lead, cadmium, antimony, mercury and arsenic) in finished products ≤ 1 mg/kg

Documentation

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.

Transitional provisions

  1. 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.
  2. 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:
Laureen Leung
laureen.leung@intertek.com
+852 3760 6361

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