The European Commission has approved to amend Regulation (EU) No 10/2011 by Regulation (EU) 2017/752 regarding plastic materials and articles intended to come into contact with food
On April 29, 2017, The European Commission has approved to amend Regulation (EU) No 10/2011 by Regulation (EU) 2017/752 regarding plastic materials and articles intended to come into contact with food.
Annexes I, II, III and IV to Regulation (EU) No 10/2011 are amended in accordance with the Annex to (EU) 2017/752 as follows:
1. Six entries were added to Table 1 of Annex I: Union list of authorised substances for manufacturing plastic food contact materials and articles.
2. Specific migration test methods for ten listed substances on the Union list (Table 1 of Annex I) are now available. Therefore the possibility to verify compliance for these substances by residual content per food contact surface area (QMA) was ｄｅｌｅｔｅd.
3. Added a new requirement of heavy metal migration to point 1 of Annex II as: Nickel = 0, 02 mg/kg food or food simulant. The ｕｐｄａｔｅd limit of heavy metal migration as follow:
|
Substance
|
Limit
（mg/kg food or food simulant）
|
Substance
|
Limit
（mg/kg food or food simulant）
|
Aluminum
(Al)
|
1
|
Iron
(Fe)
|
48
|
Barium
(Ba)
|
1
|
Lithium
(Li)
|
0.6
|
Cobalt
(Co)
|
0.05
|
Manganese
(Mn)
|
0.6
|
Copper
(Cu)
|
5
|
Zinc
(Zn)
|
5
|
Nickel
(Ni)
|
0.02
|
|
|
4. Amended food simulant assignment for testing overall migration in point 4 of Annex III as below table :
|
Foods covered
|
Food simulants in which testing shall be performed
|
|
all types of food
|
1.distilled water or water equivalent quality or food simulant A;
2.food simulant B; and
3.food simulant D2.
|
|
all types of food except for acidic foods
|
1.distilled water or water of equivalent quality or food simulant A; and
2.food simulant D2
|
|
all aqueous and alcoholic foods and milk products
|
food simulant D1
|
|
all aqueous, acidic and alcoholic foods and milk products
|
1.food simulant D1; and
2.food simulant B.
|
|
all aqueous foods and alcoholic foods up to an alcohol content of 20%
|
food simulant C
|
|
all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20%
|
1.food simulant C; and
2.food simulant B.
|
5. According to the amendment to Annex IV concerning the written Declaration of Compliance (DoC) for plastic food contact materials and articles, business operators report the food contact surface area to volume ratio used for verifying the migration limit compliance in the DoC, the highest surface area to volume ratio shall be declared.
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, may be placed on the market until May 19, 2018 and may remain on the market until exhaustion of stocks. The amendments shall be enforced from May 19, 2017, except the specific migration limit of nickel shall be effective from May 19, 2019.
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