On April 29, 2017, the Official Journal of the European Union (OJ) releases the regulation (EU) 2017/752 to amend and correct Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, allowing six new substances, adding the migration limit of nickel, and further explicating the food simulants with overall migration so as to reflects the most recent findings. Besides, the amendment corrects the textual errors in the regulation and clarifies ambiguous requirements. The regulation will come to effect from May 19, 2017.
According to the amendment (EU) 2017/752, the main changes are listed as follows:
| Amendment to the limitation of certain substances
1. Adding allowable substances number 1007, 1016, 1030, 1055, 1060, 1062 and their requirement into the list of allowable substances of table 1 of Annex I;
2. Deleting the note ‘(1)’ of the compliance demonstration of substances numbers 142, 168, 202, 387, 462, 467, 481, 502, 662 and 779 (Compliance is therefore verified by residual content per food contact surface area (QMA) pending the availability of an analytical method for determining the specific migration);
3. As for the additive α-tocopherol acetate with FCM No 1055, note 24 is added to declare that this substance as well as its hydrolyzate are both authorized food additives, and it should be verified that if they meet the requirement of the point 3 in the article 11 of this regulation;
4. Adding a migration limit of 0.02 mg/kg food to the migration of nickel from plastic food contact materials in the limitation of material and article in Annex II.
| Amendment to the testing of products
For further defining the overall migration limit food simulants of the food contact materials that expected to get touch with all kinds of food, the following table will substitute the former expressions:
Foods covered | Food simulants in which testing shall be performed |
all types of food | 1. distilled water or water of equivalent quality or food simulant A (10% ethanol); 2. food simulant B (3% acetic acid); and 3. food simulant D2 (vegetable oil). |
all types of food except for acidic foods | 1. distilled water or water of equivalent quality or food simulant A (10% ethanol); and 2. food simulant D2 (vegetable oil). |
all aqueous and alcoholic foods and milk products | food simulant D1 (50% ethanol) |
all aqueous, acidic and alcoholic foods and milk products | 1. food simulant D1 (50% ethanol); and 2. food simulant B (3% acetic acid). |
all aqueous foods and alcoholic foods up to an alcohol content of 20 % | food simulant C (20% ethanol) |
all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 % | 1. food simulant C (20% ethanol); and 2. food simulant B (3% acetic acid). |
| Amendment to the Declaration of Compliance
In the message contained in the Declaration of Compliance of Annex IV to the Regulation (EU) No 10/2011, point 8(iii), which discusses the operating specification of material or article, changes the expression from “the ratio of food contact surface area to volume” to “the verified and the most stringent surface to volume ratio (S/V)”.
As the amendment (EU) 2017/752 takes into effect, the food contact plastic material and article that apply to regulation (EU) No 10/2011 can launch until emptying stocks before May 19, 2018.
Moreover, the migration limit of nickel will apply from May 19, 2019.What is worth noting is that EU released the amendment (EU) 2016/1416 so as to add the migration limit of nickel of 1 mg/kg and tighten the migration limit of zinc to 5 mg/kg, which will enforce from September 14, 2018. Since then, the requirement of EU to the food contact plastic material and article increases to 9 terms. C&K Testing informs relevant corporations of submitting products for inspection and discussing a specific project to improve their quality based on the adequate appreciation of this regulation.
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