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Conformity assessment and marking |
Approval |
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- Description:
- Before placing a covered product on the market or putting it into service, manufacturers must carry out or have carried out the specified conformity assessment, draw up technical documentation, issue an EU declaration of conformity and affix the CE marking.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Physical goods, components and intermediate products covered by a delegated act
- Checking responsibility:
- Manufacturer
- Check method:
- Conformity assessment and technical documentation
- Rule set:
-
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- Source reference:
- Article 27(2)
- Source excerpt:
- Before placing a product covered by a delegated act adopted pursuant to Article 4 on the market or putting it into service, manufacturers shall carry out the conformity assessment procedure specified in that delegated act, or have it carried out on their behalf, and draw up the required technical documentation.
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Ongoing product conformity |
Governance |
-
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- Description:
- Manufacturers must maintain procedures ensuring that series-produced products remain compliant, take account of changes and carry out a reassessment where necessary.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Products covered by delegated acts
- Checking responsibility:
- Manufacturer
- Check method:
- Review of production processes, product design and technical specifications
- Rule set:
-
-
- Source reference:
- Article 27(4)
- Source excerpt:
- Manufacturers shall ensure that procedures are in place to ensure that products covered by a delegated act adopted pursuant to Article 4 which are part of a series production remain in conformity with the applicable requirements.
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Retention of conformity documentation |
Record Keeping |
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- Description:
- Manufacturers must retain the technical documentation and EU declaration of conformity for ten years after placing the product on the market or putting it into service, unless a different period is specified.
- Frequency:
- One-time
- Check frequency:
- One-time
- Products/Services:
- Products covered by delegated acts
- Checking responsibility:
- Manufacturer; competent national authorities on request
- Check method:
- Retention and production of documentation
- Rule set:
-
-
- Source reference:
- Article 27(3)
- Source excerpt:
- Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after a product covered by a delegated act adopted pursuant to Article 4 has been placed on the market or put into service
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Digital product passport and identification |
Record Keeping |
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- Description:
- Manufacturers must make products identifiable, provide their contact details and make an up-to-date digital product passport, including a backup copy, available.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Products covered by delegated acts
- Checking responsibility:
- Manufacturer
- Check method:
- Review of the digital product passport and product identification
- Rule set:
-
-
- Source reference:
- Article 27(1)(c)
- Source excerpt:
- a digital product passport is available in accordance with Article 9 and the delegated acts adopted pursuant to Article 4, including a back-up copy of the most up-to-date version of the digital product passport stored by a digital product passport service provider in accordance with Article 10(4).
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Product instructions |
Record Keeping |
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- Description:
- Manufacturers must provide understandable digital instructions, supply safety information on paper and keep the digital instructions accessible online for at least ten years.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Products covered by delegated acts
- Checking responsibility:
- Manufacturer
- Check method:
- Provision of digital and required paper instructions
- Rule set:
-
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- Source reference:
- Article 27(7)
- Source excerpt:
- The manufacturer shall present the digital instructions in a format that makes it possible to download and save them on an electronic device so that the user can access them at all times and shall make them accessible online during the expected lifetime of the product, but in any event for at least 10 years
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Prevention of destruction |
Governance |
-
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- Description:
- Economic operators must take all reasonably expected necessary measures to prevent the destruction of unsold consumer products.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Unsold consumer products
- Checking responsibility:
- Economic operators
- Check method:
- Internal prevention measures
- Rule set:
-
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- Source reference:
- Article 23
- Source excerpt:
- Economic operators shall take necessary measures which can reasonably be expected to prevent the need to destroy unsold consumer products.
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Annual disclosure of discarded products |
Reporting |
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- Description:
- Covered companies must annually disclose the number and weight, reasons, disposal routes, and measures taken and planned to prevent destruction, and provide supporting evidence within 30 days upon request.
- Frequency:
- Annual
- Check frequency:
- Annual
- Products/Services:
- Unsold consumer products discarded directly or on behalf of the company; excluding micro and small enterprises unless a different rule applies
- Checking responsibility:
- Economic operators that discard or arrange for the discarding of such products
- Check method:
- Publication on an easily accessible website; supporting evidence on request
- Rule set:
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- Source reference:
- Article 24(1)
- Source excerpt:
- Economic operators shall disclose the information referred to in the first subparagraph on an annual basis and shall include as part of that information the unsold consumer products discarded during the preceding financial year.
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Prohibition of destruction of specified products |
Other |
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- Description:
- Companies must not destroy the unsold consumer products listed in Annex VII and must not supply products to other companies for the purpose of circumventing the prohibition.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Unsold consumer products in the product groups listed in Annex VII
- Checking responsibility:
- Economic operators; medium-sized enterprises from 19 July 2030
- Check method:
- Review of disposal decisions and inventory
- Rule set:
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- Source reference:
- Article 25(1)
- Source excerpt:
- From 19 July 2026, the destruction of unsold consumer products as listed in Annex VII shall be prohibited.
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Importer due diligence |
Due Diligence |
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- Description:
- Importers may place only compliant products on the market and must beforehand verify the conformity assessment, technical documentation, information, digital product passport, markings and manufacturer details.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products covered by delegated acts
- Checking responsibility:
- Importers
- Check method:
- Verification of conformity, marking, documentation and digital product passport before placing on the market
- Rule set:
-
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- Source reference:
- Article 29(2)
- Source excerpt:
- Before placing a product covered by a delegated act adopted pursuant to Article 4 on the market, importers shall ensure that:
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Distributor due diligence |
Due Diligence |
-
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- Description:
- Before making products available on the market, distributors must verify the required markings, documents, instructions, digital product passport and manufacturer and importer details.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products covered by delegated acts
- Checking responsibility:
- Distributors
- Check method:
- Visual and documentary verification of markings, documents, instructions and product passport
- Rule set:
-
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- Source reference:
- Article 30(2)
- Source excerpt:
- Before making a product covered by a delegated act adopted pursuant to Article 4 available on the market, distributors shall verify that:
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Product information and labels in sales |
Record Keeping |
-
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- Description:
- Dealers must make relevant product information and the digital product passport accessible to customers and potential customers, visibly display required labels and refrain from misleading labels.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products covered by delegated acts in physical and distance sales
- Checking responsibility:
- Dealers
- Check method:
- Display of information, product passports and labels in the sales offer
- Rule set:
-
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- Source reference:
- Article 31(1)
- Source excerpt:
- Dealers shall ensure that their customers and potential customers have access to any relevant information accompanying products
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Compliant fulfilment conditions |
Governance |
-
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- Description:
- Fulfilment service providers must ensure that their warehousing, packaging, addressing and dispatch conditions do not jeopardise product compliance.
- Frequency:
- Continuous
- Check frequency:
- Event-triggered
- Products/Services:
- Products covered by delegated acts
- Checking responsibility:
- Fulfilment service providers
- Check method:
- Ensuring appropriate warehousing, packaging, addressing and dispatch conditions
- Rule set:
-
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- Source reference:
- Article 33
- Source excerpt:
- Fulfilment service providers shall ensure that, for products that they handle that are covered by a delegated act adopted pursuant to Article 4, the conditions during warehousing, packaging, addressing or dispatching do not jeopardise the products’ compliance with that delegated act.
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Distance-selling information |
Record Keeping |
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- Description:
- Economic operators must visibly provide manufacturer or EU economic-operator contact details and sufficient product-identification information in distance-selling offers.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products covered by delegated acts offered through distance selling
- Checking responsibility:
- Economic operators
- Check method:
- Review of the online or distance-selling offer
- Rule set:
-
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- Source reference:
- Article 36(1)
- Source excerpt:
- When making a product covered by a delegated act adopted pursuant to Article 4 available on the market through distance selling, economic operators shall ensure that the product offer clearly and visibly provides at least the following information:
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Supply-chain traceability |
Record Keeping |
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- Description:
- Economic operators must retain supplier and customer information, including quantities and models, for ten years and provide it within 15 days upon a reasoned request.
- Frequency:
- Event-triggered
- Check frequency:
- Continuous
- Products/Services:
- Products covered by delegated acts in the supply chain
- Checking responsibility:
- Economic operators
- Check method:
- Transaction records and production of records to market surveillance authorities
- Rule set:
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- Source reference:
- Article 36(2)
- Source excerpt:
- Economic operators shall ensure that they are able to provide the information referred to in the first subparagraph for 10 years after they have been supplied with the relevant products and for 10 years after they have supplied such products
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Upload to the product passport registry |
Record Keeping |
-
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- Description:
- The responsible economic operator must upload the required data to the digital product passport registry.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products with a digital product passport
- Checking responsibility:
- Economic operator placing the product on the market or putting it into service
- Check method:
- Uploading unique identifiers and required data to the registry
- Rule set:
-
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- Source reference:
- Article 13(4)
- Source excerpt:
- The economic operator placing the product on the market or putting it into service shall upload, in the registry, the data referred to in paragraphs 1 and 2.
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Registration identifier for customs |
Record Keeping |
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- Description:
- The relevant person must provide or make available the product’s unique registration identifier to customs authorities.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products intended to be placed under the customs procedure release for free circulation
- Checking responsibility:
- Person intending to place the product under release for free circulation
- Check method:
- Provision of the unique registration identifier to customs authorities
- Rule set:
-
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- Source reference:
- Article 15(1)
- Source excerpt:
- Any person intending to place a product covered by a delegated act adopted pursuant to Article 4 under the customs procedure ‘release for free circulation’ shall provide or make available to customs authorities the unique registration identifier of that product referred to in Article 13(5).
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Corrective action for non-compliance |
Other |
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- Description:
- Where non-compliance is suspected, manufacturers and importers must promptly correct, withdraw or recall the product where appropriate and inform market surveillance authorities.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products covered by delegated acts
- Checking responsibility:
- Manufacturers and importers
- Check method:
- Correction, withdrawal or recall and notification to authorities
- Rule set:
-
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- Source reference:
- Article 27(8)
- Source excerpt:
- Manufacturers that consider or have reason to believe that a product covered by a delegated act adopted pursuant to Article 4 that they have placed on the market or put into service is not in conformity with the requirements set out in that delegated act shall without undue delay take the necessary corrective action to bring that product into conformity, or to immediately withdraw or recall it, if appropriate.
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Information duty to authorities |
Reporting |
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- Description:
- Manufacturers, importers and distributors must provide the information and documentation necessary to demonstrate conformity within 15 days of a reasoned request.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Products covered by delegated acts
- Checking responsibility:
- Manufacturers, importers and distributors
- Check method:
- Provision of information and documentation to competent authorities
- Rule set:
-
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- Source reference:
- Article 27(10); Article 29(8); Article 30(5)
- Source excerpt:
- That information and documentation shall be provided in paper or electronic form, as soon as possible and in any event within 15 days of receipt of a request by that authority.
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Prevention of circumvention |
Governance |
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- Description:
- Economic operators must not use conduct, testing instructions, product designs or software updates that manipulate compliance tests or improperly worsen performance after commissioning.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Products covered by a delegated act
- Checking responsibility:
- Economic operators
- Check method:
- Review of product and software design and testing instructions and updates
- Rule set:
-
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- Source reference:
- Article 40(1)
- Source excerpt:
- Economic operators shall not engage in any behaviour that undermines the compliance of products with this Regulation regardless of whether that behaviour is of a contractual, commercial, technical or other nature.
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Emtract Ingest