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EU: regulation (EU) 2020/1245 amends regulation (EU) no. 10/2011 on plastic materials and articles of FCM

SEPTEMBER 2020 - ELECTRICAL AND ELECTRONICS, HARDLINES, TOYS AND CHILDREN'S PRODUCTS

On 3 September 2020, the Official Journal of the European Union (OJEU) published Regulation (EU) 2020/12451 to amend Regulation (EU) no. 10/20112 on plastic materials and articles intended to come into contact with food. 

The amendment will enter into force on 23 September 2020 (twentieth day following its publication in OJEU). The following is a brief summary of the key changes in Annexes I, II, IV and V of Regulation (EU) no. 10/2011

Annex I – Substances

Table 1 - Union list of authorized substances

 

  • Adding detection limit of 0.002mg/kg food or food simulant to 1,3-phenylenediamine (Entry 236)(CAS No. 108-45-2)
  • Specific migration limit (SML) – 0.04mg/kg food or food simulant and note on compliance verification for antimony trioxide (Entry 398)(CAS No. 1309-64-4) are also included in Annex II.
  • Adding three new authorised substances : 
  1. Entry 1075: Montmorillonite clay modified with hexadecyltrimethylammonium bromide
  2. Entry 1076: Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl ester (CAS No. 1227937-46-3)
  3. Entry 1077: Titanium dioxide surface-treated with fluoride-modified alumina

Annex II - Restrictions on materials and articles

Point 1 – New table for 24 substances

There is a new “Table 1” listing substances that must only be used in accordance with compositional requirement in Chapter II or may only be present as impurity subject to restrictions specified in the table. 
This Table 1 consolidates metals in point 1 of Annex II, a list of permitted salts of authorized acids, phenols, and alcohols from Article 6.3(a), and newly includes specific migration limits for certain metals.

Summary table of the new metals with SML in Annex II

Metals 

SML

(mg/kg food or food stimulant)

Antimony 0.041
Arsenic ND (Detection limit = 0.01 mg/kg)
Cadmium ND (Detection limit = 0.002 mg/kg)
Chromium ND(Detection limit = 0.01 mg/kg)
Europium 0.053
Gadolinium 0.053
 Lanthanum 0.053 
Lead  ND (Detection limit = 0.01 mg/kg)
 Mercury ND (Detection limit = 0.01 mg/kg)
 Terbium 0.053

Remark: 

  1. Note in Annex I, Table 1, FCM No.398: SML might be exceeded at very high temperature.
  2. If pre-existing documentary evidence can prove chromium(VI) is excluded, limit of 3.6mg/kg must be applied.
  3. Lanthanide substances (Europium, Gadolinium, Lanthanum and Terbium) can be used in accordance with Article 6(3)(a) provided that : 
  • sum of all Lanthanide substances migrating to food or food simulant must not exceed the SML- 0.05 mg/kg.
  • Analytical evidence using methodology demonstrating Lanthanide substance(s) present in dissociated ionic form in food or food simulant ,forms part of documentation referred to Article 16.

Point 2 - Primary aromatic amines

Detection limit for primary aromatic amines (PAAs) will be amended as below:

  1. The PAAs listed in entry 43 to Appendix 8 of Annex XVII to REACH Regulation (EC) no.1907/2006 and for which no migration limit is specified in Table 1 of Annex I must not be detected with detection limit - 0.002 mg/kg food or food simulant applied to each individual PAA.
  2. The PAAs not listed in entry 43 to Appendix 8 of Annex XVII to REACH Regulation (EC) no.1907/2006 and for which no migration limit is specified in Table 1 of Annex I, compliance with Article 3 of Regulation (EC) no. 1935/2004 must be verified according to Article 19. The sum of those PAAs must not exceed 0.01 mg/kg in food or food simulant.

Annex IV - Declaration of compliance

Point 6

Adequate information (including identification and amount) for substances in intermediate materials is required to include in the declaration of compliance. Those substances meet the following criteria:

  1. are subject to restrictions in Annex II and
  2. have genotoxicity which is not ruled out.

Annex V - Compliance testing

Chapter 2 - Testing for specific migration of materials and articles not yet contact with food

Point 2.1.3 - Conditions of contact when using food simulants

New testing rules for specific migration of plastic materials or articles in food processing equipment or appliance are added. Determining the specific migration into food or food simulant can also be carried out by whole equipment or appliance, or a part thereof. The key changes are as below:

The food or food simulant is processed by the whole equipment or part thereof in accordance with the worst foreseeable conditions that can be achieved if the equipment or part is operated in accordance with its instruction. 

The migration for storage parts in the equipment, such as reservoirs, containers, capsules or pads is determined by using conditions representative for their use (unless the applied conditions for whole tested equipment or appliance is representative also to their use).

When the result is not in compliance with the Regulation, the source of non-compliance must be determined whether it is from a plastic part or a part made of another material. The non-compliance to the regulation must only be established if it originates from a plastic part.

Point 2.1.6 - Repeated use articles

The stability of material must be verified during three subsequent specific migration tests. If the migration (above level of detection in any of three migration tests) increases from first to third migration, the compliance of the material must not be established because of insufficient stability (even the SML is not exceeded in any of three tests).

 

Chapter 3 - Testing for overall migration

Point 3.1 - Standardised testing conditions 

The amendments are listed as below and highlighted in the table selected from Table 3 – standardised conditions for testing the overall migration:
  • A new testing condition (OM0) for overall migration is added;
  • Reflux condition is added in OM4 as an option if 100°C is technically difficult to be applied. 

Selected part from Table 3 - standardised conditions for testing the overall migration.

 Test Number

Contact time and
temperature for testing

Intended food 
contact conditions

 OM0 30 mins at 40°C

Any food contact at cold or
ambient temperatures and for a
short duration (≤ 30 minutes)

 OM4 1 hour at 100°C
or at reflux

High temperature applications
for all types of food at temperature
up to 100°C


Point 3.2 - Substitute overall migration tests for tests with food simulant D2 and Point 3.3.2 - Repeated use articles and materials

In Point 3.2 and 3.3.2, some editorial changes are made. 

In Point 3.2, it is clarified that only one replacement test (either OM8 or OM9) must be selected if it is technically not feasible to perform test OM7. Subsequently, the migration test must be done at each of the two conditions specified for the selected test with new test sample for each condition. Compliance with the Regulation must be established by using the test condition with higher overall migration result.

Test number  Test conditions Intended food
contact conditions
 OM8 Food simulant E for 2 hours at 175°C
and food simulant D2 for 2 hours at 100°C
High temperature applications
only 
 OM9 Food simulant E for 2 hours at 175°C
and food simulant D2 for 10 days at 40°C
High temperature applications
including long term storage at room temperatures

Transition Period 
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before 23 September 2020 and which were first placed on the market before 23 March 2021 may continue to be placed on the market until 23 September 2022 and remain on the market until exhaustion of stocks.

[1]  Regulation (EU) 2020/1245

[2]  Regulation (EU) No 10/2011 (consolidated version to 29 August 2019)

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