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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 11 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.
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)
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.
|Volatile organic matter (VOM)||≤ 0.5 % m/m ± 0.1 % m/m|
Products other than baby bottle teats and soothers for infants and young children:
Baby bottle teats and soothers for infants and young children (in accordance with the conditions and criteria laid down in Annex IV):
|Primary aromatic amine and secondary aromatic amine||
|Formaldehyde and Hexamethylenetetramine||
|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)
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