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On Aug. 11, 2020, the Ministry of Economy, Finance and Recovery of France published the new “Order of Aug. 5, 2020”, relating to rubber materials and articles intended to come into contact with foodstuffs and pacifiers for infants and young children. The new law replaces and repeals the Order of November 9, 1994, which covered rubber materials and articles intended to be in contact with food and drink.

The new legislation (applicable to natural rubber and vulcanized thermoplastic elastomers, excluding silicone elastomers) introduces several important updates to the lists of authorized substances. Additionally, there are restructured rules for verifying the conformity of rubber materials and articles, along with establishing a new requirement for declaration of compliance.

The new order will enter into force on July 1, 2021. Respective products which comply “with the existing order before the new order enters into force, and which were placed on the market for the first time before July 1, 2021, may continue to be marketed until stocks are exhausted”.

Please see below for important provisions in the new order:

ORDER OF AUGUST 5, 2020 RELATING TO RUBBER MATERIALS AND ARTICLES INTENDED TO COME INTO CONTACT WITH FOOD AND PACIFIERS FOR INFANTS AND YOUNG CHILDREN 

SECTION — Article 1

CONTENT:

  • Food contact rubber materials and articles, rubber pacifiers for infants and young children, as well as intermediate materials and substances used in their manufacture
  • Bottle nipples (teats) for infants and young children that are made of elastomer or rubber when specifically mentioned in the law

SECTION — Article 3

CONTENT:

  • Rubber materials are to be manufactured using substances falling under Annex I ‘Monomers, starting substances and authorized modifier agents’, subject to the specifications therein
  • They can be produced using chemicals under Annex VIII ‘List of authorized constituents subject to the submission of application necessary for their evaluation before July 1, 2025’, unless an assessment dossier is submitted before the date and authorization of use is granted

SECTION — Article 4

CONTENT:

  • Only additives in Annex II may be used in the manufacture of rubber materials and articles
  • Dyes and pigments must conform to the purity criteria in Annex VII for heavy metals, aromatic amines and polychlorinated biphenyls (PCBs)
  • The use of nanoform substances is prohibited unless these are authorized or mentioned in Annex II and VIII

SECTION — Article 6

CONTENT:

Food contact rubber materials and articles in their finished state are obliged to comply with the following:

  • Volatile organic matter
  • Specific migration of n‑nitrosamines and n‑nitrosatable substances
  • Specific migration of primary aromatic amines and secondary aromatic amines
  • Specific migration of formaldehyde and hexamethylenetetramine
  • Total content of lead, cadmium, antimony, mercury and arsenic
  • Negative reaction to peroxides
  • Specific migration of metals (barium, copper, aluminium, zinc)

SECTION — Article 7

CONTENT:

Details the compliance control for SMLs and OMLs, including the table of testing conditions in Annex III for measuring SMs and OMs

SECTION — Article 8

CONTENT:

Bottle nipples (teats) and pacifiers made of elastomeric and rubber materials for infants and young children are to tested according to the method in Part A to Annex IV for n‑nitrosamines and n‑nitrosatable substances

SECTION — Article 12

CONTENT:

Details the requirements for a DoC, including the information required in Annex V

 

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