EU Proposes Revision to Food Contact Plastics Regulation, (EU) 10/2011

The European Union (EU) has published a new
draft regulation that, if approved, will amend and correct Regulation (EU)
10/2011 on food contact plastics.

The draft regulation is a comprehensive proposal
that contains important changes to:

Annex I, Table 1 of ‘Union List of Authorized

  • A completely new detection limit of 0.002 mg/kg for 1,3-phenylenediamine (1,3-diaminobenzene, CAS 108-45-2)
  • Addition of three new entries, including titanium dioxide surface-treated with fluorine-modified alumina

Annex II, ‘Restrictions on Materials and Articles’ is completely replaced:

  • New Table 1 defines the specific migration limit (SML) for 19 substances where some substances are subject to certain conditions and adds five substances where their migration is subject to Articles 11(3) and 12. Substances include:

o Aluminum

o Ammonium

o Antimony

o Arsenic

o Barium

o Cadmium

o Calcium

o Chromium

o Cobalt

o Copper

o Europium

o Gadolinium

o Iron

o Lanthanum

o Lead

o Lithium

o Magnesium

o Manganese

o Mercury

o Nickel

o Potassium

o Sodium

o Terbium

o Zinc

  • ≤ 0.002 mg/kg for each primary aromatic amine (PAA) listed in Appendix 8 to entry 43 of Annex XVII of Regulation (EC) 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)’ where there is no migration limit in Table 1 to Annex I
  • ≤ 0.01 mg/kg for the sum of PAAs not listed in Appendix 8 to entry 43 of Annex XVII of REACH where there is no specific limit in Annex I – this obligation is to be verified in accordance with Article 19 of the Regulation ‘Assessment of Substances not Included
    in the Union List’

Annex IV, ‘Declaration of Compliance’ – point
6 replaced to include information on the quantity of substances in intermediate

Annex V, ‘Compliance Testing’:

  • Amends point
    2.1.3 to Chapter 2 ‘Conditions of contact when using food simulants’:

o Adds new point (iv) on defining rules for the migration
of plastic materials or components in food processing equipment or appliances

  • Replaces
    point 2.1.6 to Chapter 2 ‘Repeated Use Articles’:

o The migration test(s) for repeated use food contact
materials and articles are obliged to be carried out three times on a single
sample using a fresh portion of simulant on each occasion. The specific
migration value for each occasion must not be higher than the value in the
preceding migration test. Although compliance for migration is based on the
third test, compliance cannot be established if the migration value increases
from the first migration test to third migration test even if the SML is not
exceeded in any of the three tests

  • Replaces
    Table 3 under point 3.1 to Chapter 3 ‘Standardized Conditions for Testing the
    Overall Migration’:

o New Test Number OM0 (40 °C, 30 minutes) for any food
contact at cold or room temperatures with no more than 30 minutes

o ‘or at reflux’ added to the testing conditions in OM4

o Editorial changes to footnote to reflect OM0

To learn more about the substances listed in Annex II, Table 1,
view our original SafeGuardS

If approved, the new law will enter into
force twenty days after it is published in the Official Journal of the EU

Stakeholders should be aware that food
contact plastics in compliance with the current Regulation,
(EU) 10/2011, and which were placed onto the
market within six months of the date of entry into force of the new regulation,
can continue to be placed onto the market for two years and remain there until
stocks are exhausted.

SGS Food Contact Material Services

SGS’s technical experts have extensive experience of testing materials and
articles in contact with food. They can ensure that your products meet the
appropriate regulations for food contact materials and pave the way for
compliance. SGS offers the full range of testing, including migration tests,
along with expert advice on emerging regulations, compliance issues and
documentation review.
Learn more about SGS’s Food Contact Material Services.

SGS SafeGuardS keep you up to date with
the latest news and developments in the consumer goods industry. Read the full
EU Proposes to Revise Food Contact
Plastics Regulation

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For further information contact:

Hing Wo Tsang

Global Information and Innovation Manager

Tel:(+852) 2774 7420



LinkedIn: sgs-consumer-goods-&-retail

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