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Compliant use of claims |
Due Diligence |
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- Description:
- Use nutrition and health claims only when they comply with the general principles and are not false, ambiguous or misleading, do not encourage excessive consumption and do not contain other prohibited statements.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Foods bearing nutrition or health claims in commercial communications
- Checking responsibility:
- Food business operator
- Check method:
- Check claims against the general and specific requirements of the Regulation
- Rule set:
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- Source reference:
- Article 3; Article 5(1)
- Source excerpt:
- Nutrition and health claims may be used in the labelling, presentation and advertising of foods placed on the market in the Community only if they comply with the provisions of this Regulation.
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Scientific substantiation and evidence |
Due Diligence |
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- Description:
- Justify each nutrition or health claim with generally accepted scientific data and produce all relevant supporting elements and data on request.
- Frequency:
- Event-triggered
- Check frequency:
- Continuous
- Products/Services:
- Foods for which a nutrition or health claim is made
- Checking responsibility:
- Food business operator
- Check method:
- Scientific substantiation and, where requested, production of relevant supporting materials to competent authorities
- Rule set:
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- Source reference:
- Article 6(1)-(3)
- Source excerpt:
- A food business operator making a nutrition or health claim shall justify the use of the claim.
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Provide nutrition information |
Record Keeping |
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- Description:
- Provide the nutrition information required under the nutrition-labelling rules, mutatis mutandis, when making a health claim, and where applicable state the amounts of the relevant substances in the same field of vision.
- Frequency:
- Event-triggered
- Check frequency:
- Continuous
- Products/Services:
- Foods bearing a nutrition or health claim
- Checking responsibility:
- Food business operator
- Check method:
- Review of labelling and nutrition information for the required information
- Rule set:
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- Source reference:
- Article 7
- Source excerpt:
- The obligation and the modalities for providing information pursuant to Directive 90/496/EEC where a nutrition claim is made shall apply, mutatis mutandis, where a health claim is made, with the exception of generic advertising.
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Accompanying information for health claims |
Record Keeping |
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- Description:
- For health claims, include a statement on the importance of a varied and balanced diet and a healthy lifestyle, the required quantity and consumption pattern, and, where appropriate, avoidance advice or a warning.
- Frequency:
- Event-triggered
- Check frequency:
- Continuous
- Products/Services:
- Foods bearing health claims
- Checking responsibility:
- Food business operator
- Check method:
- Review of labelling, presentation or advertising for the required accompanying information
- Rule set:
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- Source reference:
- Article 10(2)
- Source excerpt:
- Health claims shall only be permitted if the following information is included in the labelling, or if no such labelling exists, in the presentation and advertising
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Requirements for comparative claims |
Due Diligence |
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- Description:
- Compare only foods of the same category and with a range of such foods; state the difference in nutrient quantity or energy value and use the same quantity of food for the comparison.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Comparative nutrition claims concerning foods
- Checking responsibility:
- Food business operator
- Check method:
- Check the comparator products, quantity compared and stated difference
- Rule set:
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- Source reference:
- Article 9(1)
- Source excerpt:
- a comparison may only be made between foods of the same category, taking into consideration a range of foods of that category. The difference in the quantity of a nutrient and/or the energy value shall be stated and the comparison shall relate to the same quantity of food.
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Application for authorisation of a health claim |
Approval |
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- Description:
- For health claims requiring authorisation, submit an application containing the required particulars, scientific studies, proposed wording and a summary.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Health claims requiring an authorisation procedure
- Checking responsibility:
- Applicant or food business operator
- Check method:
- Submission of a complete application to the national competent authority
- Rule set:
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- Source reference:
- Article 15(3)
- Source excerpt:
- The application shall include the following: (a) the name and address of the applicant; ... (c) a copy of the studies ... (f) a proposal for the wording of the health claim ... (g) a summary of the application.
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Use of authorised health claims |
Approval |
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- Description:
- Use health claims only when authorised under the Regulation, included in the relevant lists and used in conformity with the applicable conditions.
- Frequency:
- Event-triggered
- Check frequency:
- Continuous
- Products/Services:
- Foods bearing health claims
- Checking responsibility:
- Food business operator
- Check method:
- Cross-check against the lists of authorised claims and their applicable conditions of use
- Rule set:
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- Source reference:
- Article 10(1)
- Source excerpt:
- Health claims shall be prohibited unless they comply with the general requirements in Chapter II and the specific requirements in this Chapter and are authorised in accordance with this Regulation and included in the lists of authorised claims
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Statement for reduction-of-disease-risk claims |
Record Keeping |
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- Description:
- For reduction-of-disease-risk claims, include a statement that the disease has multiple risk factors and that altering one risk factor may or may not have a beneficial effect.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Foods whose labelling, presentation or advertising contains health claims
- Checking responsibility:
- Food business operator
- Check method:
- Review of labelling or advertising for the statement concerning multiple disease risk factors
- Rule set:
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- Source reference:
- Article 14(2)
- Source excerpt:
- the labelling or, if no such labelling exists, the presentation or advertising shall also bear a statement indicating that the disease to which the claim is referring has multiple risk factors
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Notification of placing on the market |
Reporting |
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- Description:
- Where a Member State requires it for monitoring, notify the competent authority of the placing on the market by forwarding a model of the label used for the product.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Foods bearing nutrition or health claims, where required by the competent authority
- Checking responsibility:
- Manufacturer or person placing the food on the market
- Check method:
- Submission of a model of the label used for the product to the competent authority
- Rule set:
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- Source reference:
- Article 25
- Source excerpt:
- Member States may require the manufacturer or the person placing such foods on the market in their territory to notify the competent authority of that placing on the market by forwarding to it a model of the label used for the product.
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Emtract Ingest