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The EU Releases the Latest Revised Regulation on Plastics in Contact with Food (EU) No 10/2011
Time：
2023-07-13
The European Commission has issued the latest revised regulation (EU) 2023/1442 to the Regulations on Plastics in Contact with Food (EU10/2011), which will come into effect 20 days later (August 1, 2023).
Official Journal of the European Union：https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2023.177.01.0045.01.ENG&toc=OJ%3AL%3A2023%3A177%3ATOC
01 Transitional measures
(1) Plastic materials and products that comply with the EU 10/2011 regulations applicable before the new regulations come into effect and are first placed on the market before February 1, 2025, may continue to be sold on the market until inventory is depleted.
(2) Intermediate materials and products used for the manufacture of plastic materials and products comply with the EU 10/2011 regulations applicable before the entry into force of this regulation and are first placed on the market after May 1, 2024, but do not comply with this regulation. The declaration of conformity of the intermediate material or product should indicate that it does not comply with this regulation and can only be used for the manufacture of plastic materials and articles to be placed on the market before February 1, 2025.
(3) Plastic materials and items manufactured using salicylic acid (FCM No 121) or untreated wood flour and fibers can continue to be put on the market for the first time after February 1, 2025, provided that the following conditions are met:
a. Prior to August 1, 2024, an authorization application for the substance has been submitted to the competent authority in accordance with Article 9 of Regulation (EC) No 1935/2004;
b. The use of plastic materials and items manufactured using this substance is limited to the expected usage conditions described in the application;
c. The information provided to the Authority in accordance with Article 9 (1) (b) of Regulation (EC) No 1935/2004 includes a statement stating that the application is made in accordance with this paragraph;
d. The Authority considers the application valid.
02 Revised content
This revision is the list of authorized substances in Annex I of EU10/2011. The substances mainly involved include salicylic acid, untreated wood flour and fiber, Plasticizer, Triethanolamine, Perchloric acid, antioxidant 1222, etc. The detailed information is as follows:
1. Delete untreated wood powder and fiber from substance 96 and salicylic acid from substance 121.
2. The Plasticizer is revised as follows:
The DBP migration limit was reduced from 0.3mg/kg to 0.12mg/kg;
The BBP migration limit was reduced from 30mg/kg to 6mg/kg;
The DEHP migration limit has been reduced from 1.5mg/kg to 0.6mg/kg;
The migration limit of C9 (DINP) has been reduced from 9mg/kg to 1.8mg/kg and must not be combined with the following substances (FCM NO.157, 159, 283, or 1085).
The sum of DBP, DIBP, BBP, and DEHP is expressed as the DEHP equivalent using the following equation: DBP * 5+DIBP * 4+BBP * 0.1+DEHP * 1.
3. Triethanolamine (CAS 102-71-6) migrated from the previous single substance to the sum of the group 37 substance Triethanolamine and hydrochloric acid adduct.
4. Perchlorate becomes the 38th substance, and the limit value of the sum of Perchlorate migration is 0.002mg/kg.
In addition, multiple substances such as antioxidant 1222 (CAS 976-56-7) and PHBH (CAS 147398-31-0) have been revised.
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