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France has published a new Order on rubber materials and articles intended to come into contact with foodstuffs and pacifiers for infants and young children. This new legislation will become effective on July 1, 2021.

SAFEGUARDS | Consumer ProductsNO. 128/20

SafeGuards Toddler with pacifier

On August 11, 2020, France published Order of August 5, 2020 to regulate food contact rubber materials and articles, as well as pacifiers for young children (‘new Order’). This new Order replaces and repeals the Order of November 9, 1994 (consolidated version to June 2020 for reference) relating to rubber materials and articles in contact with foodstuffs, food products and drinks.

The new law contains, inter alia, several important changes. It:

  • Clarifies the definition of rubber materials to include vulcanized thermoplastic elastomers, but not silicone elastomers

  • Updates the lists of authorized substances for the manufacture of rubber materials and articles intended to come into contact with food and pacifiers for infants and young children
  • Updates the restrictions and specifications for these authorized substances due to new scientific information, including specific migration limits (SMLs)
  • Updates certain rules for verifying the conformity of rubber materials and articles
  • Adds a completely new requirement for declaration of compliance (Doc)
  • Expresses overall migration limits (OMLs) and their requirements in one of two specifications:
    • ≤ 10 mg/dm² for 1) all articles 2) pacifiers for infants and young children and 3) gaskets, valves and valve elements where the ratio between the surface in contact with food and the volume is not known or specified
    • ≤ 60 mg/kg for 1) food contact materials and articles for infants and young children 2) bottle nipples (teats) and 3) gaskets, valves and valve elements where the ratio between the surface in contact with food and the volume is known or specified

The new Order will become effective on July 1, 2021.

Food contact rubber materials and articles complying 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.

Highlights of some important provisions in the new Order are summarized in Table 1.

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 Highlight
Article 1

Scope of Products:

  • 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) and pacifiers for infants and young children that are made of elastomer or rubber when specifically mentioned in the law
Article 3
  • 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 also 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’, subject to the specifications therein, until July 1, 2025
Article 4
  • Only additives and their conditions 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
Article 6

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

≤ 0.5% ± 0.1% (volatile organic matter, VOM)
≤ 1 µg/dm² (SM of n-nitrosamines)**
≤ 10 µg/dm² (SM of n-nitrosatable substances)**
≤ 0.01 mg/kg (SM of primary aromatic amines)
≤ 1 mg/kg (total SM of primary and secondary aromatic amines)
≤ 3 mg/kg (SM of formaldehyde)
≤ 15 mg/kg (total SM of formaldehyde and hexamethylenetetramine)
≤ 1 mg/kg for the total content of each of lead, cadmium, antimony, mercury and arsenic
Absent for peroxides

Specific migration of metals:

≤ 1.2 mg/kg (barium)
≤ 4 mg/kg (copper)
≤ 1 mg/kg (aluminum)
≤ 5 mg/kg (zinc)

*See body text for overall migration (OM)
**Do not apply to elastomeric or rubber materials in bottle nipples (teats) and pacifiers for infants and young children as these are subject to Article 8 below

Article 7 Details the compliance control for SMLs and OMLs, including the table of testing conditions in Annex III for measuring SMs and OMs
Article 8

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 the following requirements:

  • ≤ 0.01 mg/kg n-nitrosamines
  • ≤ 0.1 mg/kg n-nitrosatable substances
Article 12 Details the requirements for a DoC, including the information required in Annex V

Table 1.

SGS is committed to providing information about development in regulations for consumer products as complimentary services. Through a global network of laboratories, SGS provides a wide range of services including physical/mechanical testing, analytical testing and consultancy work for technical and non-technical parameters applicable to a comprehensive range of consumer products. Please do not hesitate to contact us for further information.

For enquiries, please contact:

Hingwo Tsang
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t: (+852) 2774 7420

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