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Plastic Materials and Articles Regulation In force

Overview

Jurisdiction
European Union
Topic
Product Safety
Instrument type
Regulation
Reference number
10/2011
Valid from
2011-05-01
Valid to
2025-02-21
Modified date
2025-02-21
Listed at
2026-08-06
Withdrawn at
-
Description
Establishes requirements for the manufacture and marketing of plastic materials and articles intended to come into contact with food, including authorised substances, compositional and migration limits, labelling, declarations of compliance, documentation, and conformity testing.

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Sources

Source URL Crawler Publish date
https://publications.europa.eu/resource/celex/02011R0010-20250316 Schokolade

Logs

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[INFO] [Crawlers::EurlexRegulationCrawler] parsed 99 norms for https://publications.europa.eu/resource/celex/02011R0010-20250316

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[INFO] [Crawlers::EurlexRegulationCrawler] parsed 99 norms for https://publications.europa.eu/resource/celex/02011R0010-20250316

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[INFO] [Crawlers::EurlexRegulationCrawler] parsed 33 norms for https://publications.europa.eu/resource/celex/02011R0010-20250316

Rule sets

Label Effective
Plastic food-contact materials and articles placed on the EU market 2011-05-01 — 9999-12-31
Applies from milestone:
Repeal (2011-05-01)
Expires at milestone:
-

No conditions.

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
Use authorised or permitted substances Due Diligence -
Description:
Use only substances included in the Union list, or substances permitted under the applicable derogations and national-law provisions.
Frequency:
Continuous
Check frequency:
Continuous
Products/Services:
Plastic materials and articles and substances used to manufacture them.
Checking responsibility:
The company and its compliance or quality function.
Check method:
Check substance identity and status against the Union list, Annex I and applicable derogations.
Rule set:
-
Source reference:
Article 5(1) and Article 6
Source excerpt:
Only the substances included in the Union list of authorised substances (hereinafter referred to as the Union list) set out in Annex I may be used in the manufacture of plastic materials and articles.
Meet compositional, purity and migration requirements Due Diligence -
Description:
Ensure that materials and articles meet the applicable compositional restrictions, purity and technical-quality requirements, specific migration limits and overall migration limits.
Frequency:
Continuous
Check frequency:
Continuous
Products/Services:
Plastic materials and articles intended for food contact.
Checking responsibility:
The manufacturer or other responsible company operator.
Check method:
Perform or obtain composition, purity and migration testing and compare results with the applicable limits.
Rule set:
-
Source reference:
Articles 8(1), 10(1), 11(1) and 12(1)
Source excerpt:
Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. Plastic materials and articles shall not transfer their constituents to food simulants in quantities exceeding 10 milligrams of total constituents released per dm2 of food contact surface (mg/dm2).
Manufacture according to good manufacturing practice Governance -
Description:
Manufacture plastic materials and articles according to good manufacturing practice.
Frequency:
Continuous
Check frequency:
Continuous
Products/Services:
Plastic materials and articles placed on the market.
Checking responsibility:
The manufacturer and its quality-management function.
Check method:
Maintain manufacturing controls conforming to Commission Regulation (EC) No 2023/2006.
Rule set:
-
Source reference:
Article 4(d)
Source excerpt:
are manufactured according to good manufacturing practice as set out in Commission Regulation (EC) No 2023/2006
Provide labelling and traceability Record Keeping -
Description:
Ensure compliance with the applicable labelling and traceability requirements.
Frequency:
Continuous
Check frequency:
Continuous
Products/Services:
Plastic materials and articles placed on the market.
Checking responsibility:
The company placing the materials or articles on the market.
Check method:
Review labels, supply-chain records and product-identification records.
Rule set:
-
Source reference:
Article 4(b) and (c)
Source excerpt:
comply with the labelling requirements set out in Article 15 of Regulation (EC) No 1935/2004; and comply with the traceability requirements set out in Article 17 of Regulation (EC) No 1935/2004
Issue and maintain declarations of compliance Record Keeping -
Description:
Make a written declaration of compliance available at non-retail marketing stages, include the information in Annex IV, identify the products covered and renew the declaration after substantial composition or production changes or new scientific data.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Plastic materials and articles, intermediate products and substances intended for their manufacture.
Checking responsibility:
The business operator issuing the declaration.
Check method:
Review the written declaration and verify its Annex IV contents and renewal triggers.
Rule set:
-
Source reference:
Article 15(1)–(3)
Source excerpt:
The written declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information laid down in Annex IV. The written declaration shall permit an easy identification of the materials, articles or products from intermediate stages of manufacture or substances for which it is issued. It shall be renewed when substantial changes in the composition or production occur that bring about changes in the migration from the materials or articles or when new scientific data becomes available.
Maintain supporting compliance documentation Record Keeping -
Description:
Make appropriate documentation demonstrating compliance available to national competent authorities on request, including testing results, calculations, analyses, safety evidence and substance composition and purity documentation.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Materials, articles, intermediate products and substances covered by the Regulation.
Checking responsibility:
The business operator; manufacturers must additionally document compliance with Article 8.
Check method:
Produce the documentation to competent authorities on request and permit official sampling.
Rule set:
-
Source reference:
Article 16(1)–(4)
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.
Provide instructions for repeated-use articles Stakeholder Engagement -
Description:
Provide users with instructions to slow deterioration, descriptions of observable deterioration changes and warnings about damage or foreseeable misuse that could increase migration or make the article unsuitable for food contact.
Frequency:
One-time
Check frequency:
Event-triggered
Products/Services:
Final plastic food-contact articles intended for repeated use.
Checking responsibility:
The manufacturer or other operator responsible for placing the article on the market.
Check method:
Review user instructions, deterioration information and warnings supplied with the article.
Rule set:
-
Source reference:
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 in accordance with Articles 15(7) and (8) of Regulation (EC) No 1935/2004 the following:

Measures

Title Due date
Maintain a substance authorisation register -
Description:
Record each substance used in manufacture and verify whether it is included in the Union list or covered by a permitted derogation.
Obligations:
  • Use authorised or permitted substances
Source reference:
Article 5(1) and Article 6
Source excerpt:
Only the substances included in the Union list of authorised substances (hereinafter referred to as the Union list) set out in Annex I may be used in the manufacture of plastic materials and articles.
Conduct migration and composition testing -
Description:
Test materials and articles using the applicable food, food-simulant and screening methods, apply correction factors and compare results with the specific and overall migration limits.
Obligations:
  • Meet compositional, purity and migration requirements
Source reference:
Article 18(1)–(7)
Source excerpt:
Before comparing specific and overall migration test results with the migration limits the correction factors set out in point 3 of Annex III and Chapter 4 of Annex V shall be applied in accordance with the rules set out therein.
Prepare Annex IV declarations of compliance -
Description:
Prepare a written declaration identifying the relevant materials, articles, intermediate products or substances and containing all information required by Annex IV.
Obligations:
  • Issue and maintain declarations of compliance
Source reference:
Article 15(2) and (3)
Source excerpt:
The written declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information laid down in Annex IV.
Compile technical compliance files -
Description:
Compile testing conditions and results, calculations, modelling, analyses, safety evidence and reasoning demonstrating compliance, including composition and purity documentation for substances.
Obligations:
  • Maintain supporting compliance documentation
Source reference:
Article 16(1) and (2)
Source excerpt:
That documentation shall contain the conditions and results of testing, calculations, including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance.

Penalties

No penalties.

Milestones

Date Type Description
2011-05-01 Application Start The Regulation applies from 1 May 2011.
Source reference:
Article 23
Source excerpt:
It shall apply from 1 May 2011.
2011-05-01 Repeal Directives 80/766/EEC, 81/432/EEC and 2002/72/EC are repealed.
Source reference:
Article 21
Source excerpt:
Directives 80/766/EEC, 81/432/EEC, and 2002/72/EC are hereby repealed with effect from 1 May 2011.
2012-12-31 Application Start The provisions on verification of migration compliance and the amendment of the food-simulant act apply from 31 December 2012.
Source reference:
Article 23
Source excerpt:
The provisions of Articles 18(2), 18(4) and 20 shall apply from 31 December 2012.
2015-12-31 Application Start Application begins for certain additive requirements for additives used in glass fibre sizing
Source reference:
Article 23
Source excerpt:
The provision of Article 5 as regards the use of additives used in glass fibre sizing for glass fibre reinforced plastics, shall apply from 31 December 2015.
2015-12-31 Application Start The rules on additives in certain caps, closures and glass-fibre sizing apply from 31 December 2015.
Source reference:
Article 23
Source excerpt:
The provision of Article 5 as regards the use of additives, others than plasticisers, shall apply for plastic layers or plastic coatings in caps and closures referred to in Article 2(1)(d), as from 31 December 2015. The provision of Article 5 as regards the use of additives used in glass fibre sizing for glass fibre reinforced plastics, shall apply from 31 December 2015.
2016-01-01 Other Supporting documents must generally be based on the Regulation's migration-testing rules from 1 January 2016.
Source reference:
Article 22(3)
Source excerpt:
As from 1 January 2016, the supporting documents referred to in Article 16 shall be based on the rules for migration testing set out in Article 18, without prejudice to paragraph 2 of this Article.

Linked regulations

Type Regulation
Cites Commission Regulation (EC) No 2023/2006
Cites Regulation (EU) No 528/2012
Cites Directive 2008/98/EC
Cites Regulation (EC) No 1333/2008
Cites Regulation (EC) No 1334/2008
Amends Council Directive 85/572/EEC
Cites REACH Regulation
Cites Regulation (EC) No 1935/2004
Cites Regulation (EC) No 1935/2004
Amends COMMISSION IMPLEMENTING REGULATION (EU) No 321/2011
Amends COMMISSION REGULATION (EU) No 1282/2011
Amends COMMISSION REGULATION (EU) No 1183/2012
Amends COMMISSION REGULATION (EU) No 202/2014
Amends COMMISSION REGULATION (EU) No 865/2014
Amends COMMISSION REGULATION (EU) 2015/174
Amends COMMISSION REGULATION (EU) 2016/1416
Amends COMMISSION REGULATION (EU) 2017/752
Amends COMMISSION REGULATION (EU) 2018/79
Amends COMMISSION REGULATION (EU) 2018/213
Amends COMMISSION REGULATION (EU) 2018/831
Amends COMMISSION REGULATION (EU) 2019/37
Amends COMMISSION REGULATION (EU) 2019/988
Amends COMMISSION REGULATION (EU) 2019/1338
Amends COMMISSION REGULATION (EU) 2020/1245
Amends COMMISSION REGULATION (EU) 2023/1442
Amends COMMISSION REGULATION (EU) 2023/1627
Amends COMMISSION REGULATION (EU) 2024/3190
Amends Plastic Food Contact Materials Regulation
Repeals Directives 80/766/EEC
Repeals 81/432/EEC
Repeals 2002/72/EC
Cites Regulation (EC) No 1272/2008
Cites Regulation (EU) No 609/2013
Cites Regulation (EU) 2017/625
Cites Directive 82/711/EEC
Cites Directive 98/83/EC
Cites Commission Regulation (EU) No 231/2012
Cites Commission Directive 2008/84/EC
Cites Commission Directive 2008/60/EC