Regulatory News

France Publishes New Rules for Rubber in Contact with Foodstuffs

Sep. 16 2020

The new Arrêté on rubber materials and articles in contact with foodstuffs was published in the Official Journal of the French Republic on August 11, 2020 and is intended to come into application on July 1, 2021. 

Major Changes 

Clarification of the status of thermoplastic elastomers by insertion of a definition of ‘vulcanized thermoplastic elastomers’. Only vulcanized TPEs are covered by the Arrêté on rubber materials. 
As a reminder, non-vulcanized TPEs are covered by the rules applicable to plastic materials (EC Regulation 10/2011) 

A new labelling for articles made of natural rubber has been included (to be labelled in French)
“Le caoutchouc naturel (issu du latex) a été utilisé dans la fabrication de cet article”
(Translation: Natural rubber (made of latex) has been used in the manufacture of this article) 

Update of lists of authorized components and associated limitations/restrictions, including requirements for colourants added to rubber and new specifications for natural rubber. 
• Major changes in specifications for finished products 
      o Volatile organic compounds : a tolerance was added, limit is now 0.5% +/- 0.1%, Annex VI of the Arrêté is providing the applicable test method 
      o Results of global migration (10 mg/dm2 or 60mg/kg) are expressed following rules: 
          -- 10 mg/dm2 for 1) all articles, 2) soothers, 3) seals, valves and valve elements where the ratio between the surface in contact with food and volume is not known or specified, 4) caps, gaskets, stoppers and other sealing articles 
          -- 60 mg/kg for 1) food contact materials and articles intended for infants and young children, 2) baby bottle teats, 3) seals, valves and valve elements where the ratio between surface area in contact with food and volume is known and specified 
      o Clarifications of test conditions to be used for the migration tests (Annex III is applicable for articles such as seals, teats, soothers…, other materials/articles are tested using the same test conditions as Regulation 10/2011), 
      o New requirements for specific migration of primary aromatic amines 
      o New requirements for heavy metals content (impurities) and specific migration limits 
      o New requirements for specific migrations of formaldehyde and of hexamethylenetetramine 

Introduction of a requirement for declaration of conformity 

Effective Date
The Arrêté is intended to come into application on 1 July 2021, materials and articles placed on the market for the 1st time before 1 July 2021 can be sold until exhaustion of stocks. 

Additional Information
Arrêté of 5 August 2020 

How Does this Impact You? Contact Us to Discuss
If you have any comments and/or questions regarding these requirements, please contact your customer service representative or