On July 12, 2023, the Official Journal of the European Union (OJ) published an amendment of Regulation (EU) No 10/2011 (EU) 2023/1422，which amends Appendix I of (EU) No 10/2011, and until to now, have been made 16 times.The bill will come into force on August 1, 2023.
Major amendments
1.Withdrawal of authorizations for the substances “untreated wood flour and fibre” (FCM No 96) and salicylic acid (FCM No 121).
2.Added three new group numbers 36 to 38, and revised the requirements for Phthalate esters, which specific comparison is in the following table.
3.Modify the requirements for the use of licensed substances.
4.Adding allowable substances to the list of authorizations.
Transitional measures
1. Plastic materials and products which comply with Regulation (EU) No 10/2011 applicable before the entry into force of this Regulation and which are placed on the market for the first time before February 1, 2025 are permitted to remain on the market until stocks are exhausted.
2. Intermediate materials and products used in the manufacture of plastic materials and articles which comply with Regulation (EU) No 10/2011 applicable before the entry into force of this Regulation and which are first placed on the market after May 1, 2024, but which do not comply with this Regulation, the declaration of conformity for that intermediate substance or product shall indicate that it does not comply with this Regulation and may only be used in the manufacture of plastic materials and articles which will be placed on the market before February 1, 2025 articles.
3. Plastic materials and products made with salicylic acid (FCM No 121) or with untreated wood flour or fibre (FCM No 96) may continue to be placed on the market in the first place after February 1, 2025, provided that the following conditions are satisfied:
(1): By August 1, 2024, an application for authorization of the substance had been submitted to the competent authority in accordance with Article 9 of Regulation (EC) No 1935/2004;
(2): The use of plastic materials and articles manufactured with this substance is limited to the intended conditions of use described in the application;
(3): The information provided to the Authority under Article 9(1)(b) of (EC) No 1935/2004 includes a declaration that the application is made under this paragraph;
(4): The Authority considers the application valid.
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Post time: Aug-10-2023
