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Ensure substance purity and composition |
Due Diligence |
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- Description:
- Ensure that substances used have a high degree of purity and technical quality suitable for the intended and foreseeable use, and that their composition is known to the substance manufacturer.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Substances used in the manufacture of plastic materials and articles, including substances manufactured from waste.
- Checking responsibility:
- The substance manufacturer and the affected manufacturers of plastic materials and articles.
- Check method:
- Assessment of composition, purity and technical quality against the intended and foreseeable use.
- Rule set:
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- Source reference:
- Article 1, point 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.
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Prevent increased migration during repeated use |
Due Diligence |
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- Description:
- Design the composition and article so that no increase in migration of constituents into food occurs during subsequent use cycles in accordance with the intended-use instructions.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Plastic materials and articles intended for repeated contact with food.
- Checking responsibility:
- Manufacturers and other responsible companies.
- Check method:
- Assessment of composition and design against subsequent use cycles and intended-use instructions.
- Rule set:
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- Source reference:
- Article 1, point 11, replacing 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.
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Inform users about deterioration |
Stakeholder Engagement |
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- Description:
- Provide users with instructions to slow deterioration, a description of observable deterioration indicators, 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:
- The manufacturer or other company responsible for placing the article on the market.
- Check method:
- Review of labelling and information provided to users.
- Rule set:
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- Source reference:
- Article 1, point 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 in accordance with Articles 15(7) and (8) of Regulation (EC) No 1935/2004 the following:
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Provide consumer instructions |
Stakeholder Engagement |
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- Description:
- Accompany the articles at sale or supply to consumers with instructions stating the restrictions and providing adequate information to avoid non-compliant conditions of use.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Plastic materials and articles subject to use restrictions that are sold or supplied to consumers at retail.
- Checking responsibility:
- Companies selling or supplying the relevant articles.
- Check method:
- Review that instructions mention the applicable food, time, temperature and heating restrictions.
- Rule set:
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- Source reference:
- Article 1, point 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.
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Maintain supporting documentation |
Record Keeping |
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- Description:
- Maintain and provide appropriate documentation to competent authorities on request to demonstrate compliance; for substances, also provide composition and purity documentation.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Plastic materials and articles, intermediate-stage products and substances intended for their manufacture.
- Checking responsibility:
- Companies; for specified documentation, manufacturers in particular.
- Check method:
- Provision of appropriate documentation and evidence to national competent authorities on request.
- Rule set:
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- Source reference:
- Article 1, point 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.
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Include required compliance evidence |
Record Keeping |
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- Description:
- Include in the documentation testing conditions and results, calculations including modelling, other analyses, and evidence or reasoning demonstrating safety or compliance.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Compliance documentation for plastic materials, articles, intermediate products and substances.
- Checking responsibility:
- Companies preparing or maintaining the compliance documentation.
- Check method:
- Verification that testing conditions and results, calculations, modelling, other analyses and safety evidence or reasoning are documented.
- Rule set:
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- Source reference:
- Article 1, point 16, Article 16(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.
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Document compliance with substance requirements |
Record Keeping |
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- Description:
- Ensure that the documentation includes evidence demonstrating compliance with the substance requirements in Article 8(1) and (2).
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Manufacturers of plastic materials and articles and of products from intermediate stages of their manufacturing.
- Checking responsibility:
- Manufacturers.
- Check method:
- Review of documentation for evidence of compliance with Article 8(1) and (2).
- Rule set:
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- Source reference:
- Article 1, point 16, Article 16(3)
- Source excerpt:
- Manufacturers of plastic materials and articles, and of products from intermediate stages of their manufacturing, shall ensure that documentation showing compliance with paragraphs 1 to 2 of Article 8 is part of the documentation referred to in paragraph 1.
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Facilitate official sampling |
Other |
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- Description:
- Ensure that competent authorities can take samples during official controls to verify purity and composition.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Manufacturing sites for plastic materials, articles and intermediate products.
- Checking responsibility:
- Manufacturers.
- Check method:
- Facilitation of official sampling during official controls.
- Rule set:
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- Source reference:
- Article 1, point 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.
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Provide information to downstream companies |
Record Keeping |
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- Description:
- Provide downstream companies with sufficient information to ensure compliance, including information on restricted substances, non-intentionally added substances, reprocessing and waste-derived substances.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Plastic substances, materials and articles and intermediate products.
- Checking responsibility:
- Downstream companies and companies issuing declarations of compliance.
- Check method:
- Review of the written declaration of compliance for the required information.
- Rule set:
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- Source reference:
- Annex I, point 2(a), replacing Annex IV, point 6
- Source excerpt:
- adequate information allowing the downstream business operators to ensure compliance with this Regulation relative to the substances used for which restrictions and/or specifications are set out in Annexes I and II, including adequate information on the presence of non-intentionally added substances if present in an amount that could cause non-compliance
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Keep reprocessing material segregated and traceable |
Record Keeping |
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- Description:
- Collect reprocessing material separately from waste, prevent contamination, prevent mixing and record transfers and traceability in the quality assurance system.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Plastic offcuts, scraps and similar by-products intended for reprocessing.
- Checking responsibility:
- Operators at every stage of reprocessing.
- Check method:
- Control of separate collection, suitable closed or designated containers, prevention of mixing and maintenance of traceability records.
- Rule set:
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- Source reference:
- Annex II, point 4, adding Section C(4)
- Source excerpt:
- 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 prior to their use in the manufacturing of plastic materials and articles, including the mixing with plastic of the same composition, shall be recorded and their traceability shall be accounted for in the quality assurance system.
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State transitional status in the declaration of compliance |
Record Keeping |
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- Description:
- State in the declaration of compliance that the product or substance does not comply with this Regulation and may only be used to manufacture materials and articles placed on the market before 16 September 2026.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Non-compliant intermediate products and substances first placed on the market after 16 December 2025.
- Checking responsibility:
- Companies placing the intermediate product or substance on the market.
- Check method:
- Review of the accompanying declaration of compliance.
- Rule set:
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- 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.
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Include reprocessing information in the declaration of compliance |
Record Keeping |
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- Description:
- In the declaration of compliance, confirm compliance of material intended for reprocessing and, where appropriate, specify its composition and provide reprocessing instructions.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Plastic materials supplied as batches intended for reprocessing.
- Checking responsibility:
- Companies placing material intended for reprocessing on the market.
- Check method:
- Review of the declaration of compliance and of composition information and reprocessing instructions.
- Rule set:
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- Source reference:
- Annex I, point 2(b), adding Annex IV, points 10(a)–(b)
- 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;
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Perform quality assessment in recycling |
Governance |
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- Description:
- Operate a quality assurance system with quality assessment stages, assess each batch at those stages, and decide whether it complies and is suitable for further processing, requires correction, or must be discarded or used for non-food applications.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Recyclers and manufacturers of recycled plastic materials and articles.
- Checking responsibility:
- The recycler.
- Check method:
- Review of the quality assurance system, critical limits, predefined criteria and batch decisions.
- Rule set:
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- Source reference:
- Annex II, point 2, adding Section B(3)
- Source excerpt:
- The quality assurance system implemented by the recycler shall include specific operations in the recycling process, “Quality Assessment Stages”, at which the recycler shall assess the quality of each batch of material directly originating from a manufacturing stage.
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Emtract Ingest