On August 1, 2023, the European Union once again revised the Food Contact Plastics Regulation (EU) No 10/2011 formal implementation. Since its first publication in 2011, it has been revised 15 times. This is the 16th revision of the regulation.

The main amendments are to revoke the two permitted substances of “untreated wood powder and wood fiber” and “salicylic acid”, to tighten the requirements for o-phthalic plasticizers, to revise the requirements for the use of permitted substances and to add new permits substance.

(EU) No10/2011 is one of the most important regulations on food contact materials in the EU. Enterprises with corresponding export business must pay attention to the revision of this regulation and adjust their production plans in time according to the policy.

Transitional measures

1. Plastic materials and articles complying with Regulation (EU) No 10/2011 applicable before the entry into force of this Regulation, which were placed on the market for the first time before 1 February 2025, may continue to be placed on the market until stocks are exhausted.

2. Products used as intermediate materials for the manufacture of plastic materials and articles which comply with the applicable Regulation (EU) No 10/2011 and are placed on the market for the first time after 1 May 2024 before the entry into force of this Regulation, but which do not comply with this Regulation, shall The declaration of conformity of a substance or product shall indicate that it does not comply with this Regulation and can only be used in the manufacture of plastic materials and articles placed on the market before 1 February 2025.

3. The use of salicylic acid (FCM No 121) or plastic materials and articles made of untreated wood flour and fibers will continue to be placed on the market for the first time after February 1, 2025, provided that the following conditions are met:

(a) submitted an application for authorization of the substance to the competent authority before 1 August 2024 in accordance with Article 9 of Regulation (EC) No 1935/2004;

(b) use the substance for the manufacture of plastic materials and articles, the use of which is limited to the conditions of intended use described in the application;

(c) the information provided to the Authority pursuant to Article 9(1)(b) of Regulation (EC) No 1935/2004 includes a statement that the application is an application subject to this paragraph;

(d) the Board considers the application valid.

4. Plastic materials and articles manufactured using the substance or untreated wood flour or fibers may continue to be used until the applicant withdraws his application, or until the Commission adopts Article 11(1) of Regulation (EC) No 1935/2004 Decide whether to approve or reject the use of the substance.

This revision involves the deletion, restriction and addition of substances, and also updated the content of the appendix of the regulations.

Modify the content

1. Clarified the failure of Food Contact Material (FCM) Substance No. 96 (untreated wood flour and fibers) and Substance No. 121 (salicylic acid);

2. Replacement of nine FCM substance numbers, including new specifications for DBP, BBP, DEHP and DINP (FCM numbers 157, 159, 283 and 728);

3. Add five new entries (FCM substance numbers 1078 and 1080-1083);

4. Replaced three entries in substance group restrictions, including consideration of DIBP in group 32 restrictions;

5. Add three new substance group restriction entries, including Group 36 restriction, where the sum of four phthalates (DBP, DIBP, BBP and DEHP) is expressed as DEHP equivalent using the defined formula.

6. Several changes of DBP, BBP, DEHP and DINP are: the migration limit of DBP is reduced from 0.3mg/kg to 0.12mg/kg; the migration limit of BBP is reduced from 30mg/kg to 6mg/kg; the migration limit of DEHP is reduced from 1.5 mg/kg reduced to 0.6mg/kg; DINP migration limit reduced from 9mg/kg to 1.8mg/kg, and must not be used in combination with the following substances (FCM No. 157, 159, 283, or 1085).

EU Food Contact Plastic Regulations
EU Food Contact Plastic Regulations

Desu advantages

After this revision, many plastic production companies will be affected, but this revision is good news for us. We have always used high-quality plastic particles for the processing of plastic sheet rolls. We can provide you with safe and reliable compliance PET plastic sheet rolls, PP plastic sheet rolls, PS plastic sheet rolls for food contact regulations.