EU REVISES FOOD CONTACT PLASTICS REGULATION

Entry

Section

Highlight

1

Annex I, Table 1
‘Union list of authorized substances’

• 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

2

Annex II
‘Restrictions on plastic materials and articles’

Completely replaces Annex II:

• New Table 1 defines the specific migration limit (SML) for 19 substances where some of the substances are subject to certain conditions, and an additional 5 substances where their migrations are subject to Articles 11(3) and 12 (see Table 2 below)
• ≤ 0.002 mg/kg for each primary aromatic amine (PAA) listed inAppendix 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 migration limit in Annex I – this obligation is to be verified in accordance with Article 19 ‘Assessment of Substances not Included in the Union List’

3

Annex IV
‘Declaration of Compliance’

Replaces point 6 to include information on the quantity of substances in intermediate materials

4

Annex V
‘Compliance Testing’

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

• 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’

• 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
• Verification of compliance is based on the level of migration found in the third test and on the basis of stability from the first to the third migration test. The stability of the material will be considered insufficient if the migration value is greater than the detection limit in any one of the three migration tests, and the value increases from the first to the third migration test. In the event of insufficient stability, compliance of the material will not be established even if the SML is not exceeded in any of the three tests
• No additional test is required if the level of migration decreases in the second and third tests and if the migration limits are not exceeded on the first test
• Regardless of the above rules, a material or article will not be considered to comply if a prohibited substance is found to migrate in detectable quantities in the first test

• Replaces Table 3 under point 3.1 to Chapter 3 ‘Standardized Conditions for Testing the Overall Migration’:
  
  New Test Number OM0 (40 °C, 30 mins) for any food contact at cold or room temperatures for no more than 30 minutes
• The words ‘or at reflux’ added to the testing conditions in OM4
• Editorial changes to footnote to reflect OM0

Entry

Name

SML (mg/kg)

Entry

Name

SML (mg/kg)

1

Aluminum¹

1

13

Iron¹

48

2

Ammonium^1,3

--

14

Lanthanum^1,6

0.05

3

Antimony^2,4

0.04

15

Lead²

ND
(Detection Limit = 0.01)

4

Arsenic²

Not Detected (ND)
(Detection Limit = 0.01)

16

Lithium¹

0.6

5

Barium¹

1

17

Magnesium^1,3

--

6

Cadmium²

ND
(Detection Limit = 0.002)

18

Manganese¹

0.6

7

Calcium^1,3

--

19

Mercury²

ND
(Detection Limit = 0.01)

8

Chromium^2,5

ND
(Detection Limit = 0.01)

20

Nickel²

0.02

9

Cobalt¹

0.05

21

Potassium^1,3

--

10

Copper¹

5