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Media Centre >> News >> The Plastic Regulation (EU) no. 10/2011 amended by (EU) no. 2018/831

The Plastic Regulation (EU) no. 10/2011 amended by (EU) no. 2018/831

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Friday, June 8, 2018

The European Commission has released Regulation (EU) no. 2018/831 which amends Regulation (EU) no. 10/2011 on Plastic materials and articles for food contact. The amendment defines new limit values for 2 substances that are already in the positive list in Annex I, and adds 2 new substances to the list.


The changes are as follows:


Substance Amendments

Perchloric acid, salts  (FCM substance No 822)

Decrease of the specific migration limit (SML) from 0.05mg/kg to 0.002mg/kg

Phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1- dimethylpropyl) phenyl triesters
(CAS 939402-02-5)
(FCM substance No 974)

Increase  of the SML  from 5 to 10mg/kg
“On the basis of new scientific evidence the Authority concluded that this substance is not of a safety concern for the consumer if its specific migration limit is increased from 5 to 10 mg/kg food, where the other existing restrictions are still met. Therefore the migration limit of this substance should be increased from 5 to 10 mg/kg, provided the other restrictions are retained”

1,2,3,4-tetrahydronaphthalene 2,6-di carboxylic acid, dimethyl ester
(CAS 23985-75-3)

New entry (FCM substance No 1066) added
The specific migration limit of the sum of the substance and its dimers (cyclic and open chain) should not exceed 0.05mg/kg food

[3- (2,3-epoxypropoxy) propyl]trimethoxy silane
(CAS 2530-83-8)

New entry (FCM substance No 1068) added
“In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer)”


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 26 June 2019 and may remain on the market until exhaustion of stocks.


Regulation (EU) no. 2018/831 can be found here


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