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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 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
(mg/kg food or food stimulant)
|Arsenic||ND (Detection limit = 0.01 mg/kg)|
|Cadmium||ND (Detection limit = 0.002 mg/kg)|
|Chromium||ND2 (Detection limit = 0.01 mg/kg)|
|Lead||ND (Detection limit = 0.01 mg/kg)|
|Mercury||ND (Detection limit = 0.01 mg/kg)|
Point 2 - Primary aromatic amines
Detection limit for primary aromatic amines (PAAs) will be amended as below:
Annex IV - Declaration of compliance
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:
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
Chapter 3 - Testing for overall migration
Point 3.1 - Standardised testing conditions
Selected part from Table 3 - standardised conditions for testing the overall migration.
Contact time and
|OM0||30 mins at 40°C||
Any food contact at cold or
|OM4||1 hour at 100°C
or at reflux
High temperature applications
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
|OM8||Food simulant E for 2 hours at 175°C
and food simulant D2 for 2 hours at 100°C
|High temperature applications
|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
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.
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