Vol. 847 | 12 Aug 2015

A draft Regulation was issued by the European Commission to propose amendments and corrections to Regulation (EU) No 10/2011 (hereinafter Regulation) on plastic materials and articles intended to come into contact with food. It is proposed to be published at the end of this year. Below are highlights of the major proposed amendments:

  1. Definitions of ‘rubber’ and 'vulcanisation' are added to avoid ambiguousness in distinguishing rubbers from plastics.
  2. The salts not included in the Union List of approved substances (set out in Annex I of the Regulation), but which are authorised subject to the specified rules, are changed to include multiple salts, acid salts, and salt hydrates.
  3. Substances listed in Annex I of the Regulation for which a restriction on the migration of oligomers is laid down in that Annex shall only be used if a suitable method of analysis for determining the migration of oligomers is published by the EU reference laboratory.
  4. For caps, gaskets, stoppers and similar sealing articles, the specific migration value shall be expressed in mg/kg instead of mg/dm2 applying the total contact surface of sealing article and sealed container if the intended use of the article is known.
  5. A new article (Article 18a) about the publication of methods of analysis by the EU reference laboratory is added.
  6. Substances not listed in the Union List or in the provisional list, which are used in a plastic layer within a plastic multi-layer material or article not in direct contact with food which is separated from the food by a functional barrier, shall also be assessed in accordance with internationally recognised scientific principles on risk assessment.
  7. The deadline for constituents of glass fibre sizing agents for glass fibre reinforced plastics which are not listed in Annex I of the Regulation to comply with the specified risk assessment provisions is postponed from 31 December 2015 to 31 December 2016.
  8. On the Union List, 8 entries concerning Food Contact Material substances are added, 1 entry is amended and 1 entry is removed.
  9. Changes to the specific migration limits are as follows:


Specific migration limit
(mg/kg food or food simulant)

Aluminum (newly-added)


Nickel (newly-added)


Zinc (existing)

5 (lowered from 25)

  1. The food simulant, vegetable oil, may be any vegetable oil that contains less than 1% of unsaponifiable matter instead.
  2. Food stimulants are assigned to fresh and chilled fruit and vegetables.
  3. Alternative food simulants are added for the situation when it is not technically feasible to perform the migration test in food simulant D2 (Vegetable Oil) under real worst foreseeable conditions of use. Food simulant E (poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm) shall be used when the worst foreseeable conditions of use exceed 100°C. The test that results in the highest specific migration shall be used to establish compliance with the Regulation.
  4. Test temperatures for materials and articles used at contact temperatures exceeding 175°C in worst foreseeable use are changed. In addition, these materials and articles shall be tested using only simulant E.
  5. The specific testing conditions for contact times above 30 days at room temperature and below are changed.


For more information, please contact:

Rob Burton
Email: rob.burton@intertek.com


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