Emtract Ingest

Plastic Food Contact Materials Regulation In force Unlisted

Overview

Jurisdiction
European Union
Topic
-
Instrument type
Regulation
Reference number
2025/351
Valid from
2025-03-16
Valid to
2026-09-16
Modified date
2025-02-21
Listed at
Unlisted draft
Withdrawn at
-
Description
Amends EU rules for plastic materials and articles intended to come into contact with food, particularly on substance purity, recycling and reprocessing, labelling, declarations of compliance, documentation and migration testing.

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Sources

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Rule sets

Label Effective
Manufacturers of plastic food contact materials and articles 2025-03-16 — 9999-12-31
Applies from milestone:
Entry into Force (2025-03-16)
Expires at milestone:
-
Conditions:
  • Products contains No Linked Attribute Value “plastic materials and articles intended to come into contact with food”
  • Activities contains No Linked Attribute Value “manufacturing plastic materials and articles”
Operators placing reusable food contact articles on the market 2025-03-16 — 9999-12-31
Applies from milestone:
Entry into Force (2025-03-16)
Expires at milestone:
-
Conditions:
  • Products contains No Linked Attribute Value “final plastic food contact articles intended for repeated use”
  • Activities contains No Linked Attribute Value “placing on the market”
Operators reprocessing plastic by-products 2025-03-16 — 9999-12-31
Applies from milestone:
Entry into Force (2025-03-16)
Expires at milestone:
-
Conditions:
  • Activities contains No Linked Attribute Value “reprocessing plastic”
  • Products contains No Linked Attribute Value “plastic offcuts” “plastic scraps” “plastic by-products”
Manufacturers of recycled plastic materials and articles 2025-03-16 — 9999-12-31
Applies from milestone:
Entry into Force (2025-03-16)
Expires at milestone:
-
Conditions:
  • Products contains No Linked Attribute Value “recycled plastic materials and articles”
  • Activities contains No Linked Attribute Value “manufacturing recycled plastic materials and articles”
Transition for compliant legacy products 2025-03-16 — 2026-09-16
Applies from milestone:
Entry into Force (2025-03-16)
Expires at milestone:
Other (2026-09-16)
Conditions:
  • Products contains No Linked Attribute Value “plastic materials and articles complying with the pre-amendment Regulation”
  • Activities contains No Linked Attribute Value “first placing on the market before 2026-09-16”

Questions this regulation asks

Attributes only this regulation asks about — criteria no general attribute expresses. A company answers each once.

This regulation asks no questions of its own — every condition uses a general attribute.

Obligations

Title Kind Rule set
Purity and technical quality of substances Due Diligence -
Description:
Companies must ensure that substances used have a high degree of purity and technical quality suitable for the intended and foreseeable use; the composition must be known to the substance manufacturer.
Frequency:
Continuous
Check frequency:
Continuous
Products/Services:
Plastic materials and articles that may come into contact with food
Checking responsibility:
Manufacturers and other affected companies
Check method:
Review of composition, purity, technical quality and intended use
Rule set:
-
Source reference:
Article 1(9), replacing Article 8(1)
Source excerpt:
Substances used in the manufacture of plastic materials and articles that may be present in the final plastic material, including those manufactured from waste, shall be of a high degree of purity and shall be of a technical quality suitable for the intended and foreseeable use of the materials or articles. The composition shall be known to the manufacturer of the substance.
Compliance with composition and reprocessing requirements Due Diligence -
Description:
Companies must ensure that plastic materials and articles meet the applicable restrictions and that reprocessed plastic is used only under the prescribed origin, collection, use and safety conditions.
Frequency:
Continuous
Check frequency:
Continuous
Products/Services:
Plastic materials and articles, including reprocessed plastic by-products
Checking responsibility:
Manufacturers and operators
Check method:
Assessment against composition requirements, migration limits and safety requirements
Rule set:
-
Source reference:
Article 1(11), replacing Article 10(1) and adding Article 10(2)
Source excerpt:
Plastic materials and articles shall meet the restrictions on plastic materials and articles laid down in Annex II. Plastic materials and articles may contain reprocessed plastic if such reprocessed plastic meets the following conditions:
Migration stability for repeated use Due Diligence -
Description:
Companies must design the composition and the article so that repeated intended use does not cause an increase in migration of constituents into food.
Frequency:
Continuous
Check frequency:
Continuous
Products/Services:
Final plastic food contact articles intended for repeated use
Checking responsibility:
Manufacturer or operator responsible for placing the article on the market
Check method:
Assessment of composition and design across subsequent use cycles
Rule set:
-
Source reference:
Article 1(11), Article 10(3)
Source excerpt:
Where intended for repeated use in contact with food, the composition and the design of final food contact articles shall be such, so as to guarantee that no increase in the migration of constituents of the material or article to the food would occur when subjected to subsequent use cycles of the articles in accordance with the instructions for intended use as described in documentation or labelling.
Information on safe repeated use Stakeholder Engagement -
Description:
Companies must provide users with instructions to slow deterioration, a description of observable deterioration changes and warnings concerning specific damage or foreseeable misuse.
Frequency:
One-time
Check frequency:
One-time
Products/Services:
Final plastic food contact articles intended for repeated use
Checking responsibility:
Manufacturer or operator responsible for placing the article on the market
Check method:
Providing use instructions, deterioration indicators and warnings to users
Rule set:
-
Source reference:
Article 1(14), Article 14a(1)
Source excerpt:
The manufacturer or other operator responsible for placing on the market a final plastic food contact article intended for repeated use, shall provide to its users ... (a) appropriate instructions designed to slow down deterioration of the article; (b) a description of observable changes of the article that may indicate the deterioration of the article or material; (c) a warning in case specific damages or foreseeable misuse would cause increased migration or would cause the article to become otherwise unsuitable for further use in contact with food.
Instructions where use restrictions apply Stakeholder Engagement -
Description:
Companies must state the applicable restrictions and provide consumers with sufficient information to prevent use under non-compliant conditions.
Frequency:
One-time
Check frequency:
One-time
Products/Services:
Plastic materials and articles subject to food-contact restrictions
Checking responsibility:
Companies selling or supplying the relevant materials or articles
Check method:
Providing instructions at sale or supply to consumers at retail stage
Rule set:
-
Source reference:
Article 1(14), Article 14a(2)
Source excerpt:
The instructions of use shall mention the restrictions and provide the consumer with adequate information to avoid using the article under conditions not complying such restrictions.
Availability of supporting documentation Record Keeping -
Description:
Companies must make suitable compliance evidence available, including composition and purity documentation for substances and testing, calculations, analyses and safety evidence.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Materials, articles, intermediate products and substances for manufacturing plastic materials and articles
Checking responsibility:
Companies and manufacturers
Check method:
Making documentation available to national competent authorities on request
Rule set:
-
Source reference:
Article 1(16), Article 16(1)
Source excerpt:
Appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Regulation shall be made available by the business operator to the national competent authorities on request.
Facilitation of official sampling Other -
Description:
Manufacturers must enable competent authorities to take samples to verify purity and composition.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Plastic materials, articles and intermediate products, and substances and materials used
Checking responsibility:
Manufacturers of plastic materials, articles and intermediate products
Check method:
Facilitating official sampling at relevant manufacturing stages and on the manufacturing site
Rule set:
-
Source reference:
Article 1(16), Article 16(4)
Source excerpt:
Manufacturers of plastic materials and articles, and of products from intermediate stages of their manufacturing, shall ensure that competent authorities can take samples during the carrying out of official controls to verify their degree of purity and their composition, including that of the substances and materials used for their manufacture.
Labelling of non-compliant transitional products Record Keeping -
Description:
Companies must state in the declaration of compliance that the product does not comply with this Regulation and may only be used to manufacture articles placed on the market before 16 September 2026.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Non-compliant substances or intermediate products first placed on the market after 16 December 2025
Checking responsibility:
Companies placing substances or intermediate products on the market
Check method:
Indicating non-compliance and the permitted use period in the accompanying declaration of compliance
Rule set:
-
Source reference:
Article 4(2)
Source excerpt:
the declaration of compliance accompanying that substance or product shall indicate that it does not comply with this Regulation, and that it can only be used in the manufacture of plastic materials and articles to be placed on the market before 16 September 2026.
Collection and traceability of reprocessing material Record Keeping -
Description:
Companies must collect by-products intended for reprocessing separately from waste, prevent contamination, prevent mixing and record batch transfers and traceability.
Frequency:
Continuous
Check frequency:
Continuous
Products/Services:
Plastic by-products and batches of material intended for reprocessing
Checking responsibility:
Operators collecting or reprocessing plastic by-products
Check method:
Separate collection, use of suitable closed or designated containers, prevention of mixing and recording of traceability
Rule set:
-
Source reference:
Annex II, section C, points 1 and 4
Source excerpt:
Plastic offcuts, scraps, and similar by-products of plastic manufacturing processes and intended to be reprocessed ... shall be collected separately from waste ... At any stage of the reprocessing of plastic, operators shall ensure that the quality assurance system prevents it from being mixed with plastic of a different composition, other materials, or with waste. The transfer of batches of plastic by-products between operations ... shall be recorded and their traceability shall be accounted for in the quality assurance system.
Declaration of compliance for reprocessing material Record Keeping -
Description:
Companies must confirm compliance with the relevant requirements in the declaration of compliance and, where appropriate, specify composition and reprocessing instructions.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Plastic materials placed on the market for reprocessing
Checking responsibility:
Companies placing material intended for reprocessing on the market
Check method:
Providing a compliance confirmation, composition and reprocessing instructions in the declaration of compliance
Rule set:
-
Source reference:
Annex I, amendment to Annex IV, point 10
Source excerpt:
when the plastic material is a batch of material intended for reprocessing: (a) the confirmation that it complies with Articles 10(1) and 10(2) of this Regulation and that it has been collected and used in accordance with point C of the Annex to Regulation (EC) No 2023/2006; and (b) as appropriate, a specification of its composition and instructions for reprocessing;

Measures

No measures.

Penalties

No penalties.

Milestones

Date Type Description
2025-02-21 Adopted Adoption of the amending Regulation by the Commission
Source reference:
Final adoption statement
Source excerpt:
Done at Brussels, 21 February 2025.
2025-02-24 Other Publication in the Official Journal of the European Union
Source reference:
Official Journal heading
Source excerpt:
2025/351 24.2.2025
2025-03-16 Entry into Force Entry into force 20 days after publication
Source reference:
Article 5
Source excerpt:
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
2025-12-16 Other Cut-off date for the first placing on the market of certain non-compliant intermediate products and substances
Source reference:
Article 4(2)
Source excerpt:
which is first placed on the market after 16 December 2025
2026-09-16 Application Start End of the transition period for first placing compliant legacy products on the market
Source reference:
Article 4(1)
Source excerpt:
which were first placed on the market before 16 September 2026 may continue to be placed on the market until the exhaustion of stocks.
2026-09-16 Other End of permitted use of certain non-compliant intermediate products and substances
Source reference:
Article 4(2)
Source excerpt:
that it can only be used in the manufacture of plastic materials and articles to be placed on the market before 16 September 2026.

Linked regulations

Type Regulation
Amends Plastic Materials and Articles Regulation
Amends Regulation (EU) 2022/1616
Repeals Regulation (EC) No 282/2008
Amends Regulation (EC) No 2023/2006
Cites Regulation (EC) No 1935/2004
Cites REACH Regulation
Cites Regulation (EU) No 528/2012
Cites Directive (EU) 2019/904
Cites Regulation (EU) 2022/1616
Cites Regulation (EU) No 528/2012
Cites Directive 2008/98/EC
Cites Regulation (EC) No 2023/2006
Cites Plastic Materials and Articles Regulation
Amends Regulation (EU) 2022/1616
Amends Regulation (EC) No 2023/2006
Cites Plastic Materials and Articles Regulation
Cites Regulation (EU) No 609/2013
Cites Regulation (EU) 2017/625