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CONSUMER PRODUCTS AND RETAIL E-SSENTIALS

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France: New Order on Rubber Food Contact Materials Published

SEPTEMBER 2020 - CHILDREN'S PRODUCTS, ELECTRICAL AND ELECTRONICS, HARDLINES, TOYS

On 22 August 2020, the Official Journal of the French Republic published Order of 5 August 20201 on rubber materials and articles intended to come into contact with food and soothers for infants and young children. 

This new Order will replace and repeal the existing Order of 9 November 19942 from 1 July 2021, and therefore has a substantial number of changes compared with the existing one.  The following is a brief summary of the key changes.

Scope (Article 1)

The scope of the new Order has clarified the definition of “rubber” to include vulcanised thermoplastic elastomers (but not silicone elastomers), and the covered products are rubber materials and articles intended to come into contact with food, and baby bottle teats and soothers for infants and young children.

Materials (Article 3)

  1. Synthetic polymers used for the manufacture of rubber materials and articles must be manufactured from the lists of monomers, starting substances and modifying agents listed in Annex I. Authorised materials listed in Annex VIII may also be used until 1 July 2025.
  2. Natural rubber must conform to the following requirements:
  • The variety of rubber has little colour and is ‘non-smoked’;
  • Does not contain p-nitrophenol, boric acid or pentachlorophenol and its sodium salts;
  • Hydroxylamine is not detectable in the finished product.

Rubber materials and articles manufactured from natural rubber must be accompanied by the following indication: ‘Natural rubber (derived from latex) was used in the manufacture of this article’, or its equivalent.

Additives (Articles 4)
Only those materials listed in Articles 4, in accordance with their respective restrictions and specifications, can be used in the manufacture of rubber materials and articles. 

Finished products (Articles 6, 7 and 8)
In addition to the restrictions and specifications laid down in Annexes I, II, VII, and VIII (where appropriate) for the starting substances, modifying agents and additives used during manufacture, rubber materials and articles in their finished product state must also comply with specific requirements and testing conditions.

The following table summarises the specific restrictions on the rubber materials and articles in their finished product state as given in Articles 6 and 8.

Table 1.  Summary of the specific restrictions on the rubber materials and articles in their finished product state as given in Articles 6 and 8 of the new Order of 5 August 2020.

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.

Declaration of Conformity (Articles 11 and 12)

Except for rubber materials and articles that are already in contact with food and intended for this purpose, a written declaration of conformity must be available at the marketing stages other than the sale or distribution free of charge to the final consumer. The details of the information required in the declaration is listed in Annex V.

Transition Period (Article 13)

  1. Rubber materials and articles placed on the market for the first time before 1 July 2021, which comply with the regulation in force before this date, may be marketed until stocks are exhausted.
  2. Rubber materials and articles into which the constituents listed in the table in Annex VIII have been incorporated and for which no marketing authorisation application dossier has been submitted before 1 July 2025, may be marketed until stocks are exhausted.

 

[1]  French Decree of 5 August 2020

[2]  French Decree of 9 November 1994

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