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General requirements for nutrition and health claims |
Due Diligence |
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- Description:
- Use nutrition and health claims only when they comply with the Regulation and are not false, ambiguous or misleading, do not encourage excessive consumption, and do not have other prohibited effects.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Foods bearing nutrition or health claims in commercial communications, including labelling, presentation and advertising
- Checking responsibility:
- Food business operator
- Check method:
- Review claims for truthfulness, clarity, non-misleading content and compliance with general and specific requirements
- Rule set:
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- Source reference:
- Article 3
- 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.
Without prejudice to Directives 2000/13/EC and 84/450/EEC, the use of nutrition and health claims shall not:
(a)
be false, ambiguous or misleading;
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Scientific substantiation and evidence for claims |
Due Diligence |
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- Description:
- Justify each nutrition or health claim with generally accepted scientific data and produce the relevant evidence and data upon request.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Foods for which a nutrition or health claim is made
- Checking responsibility:
- Food business operator making the claim
- Check method:
- Prepare scientific substantiation and produce all relevant evidence and data when requested by competent authorities
- Rule set:
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- Source reference:
- Article 6(1)-(3)
- Source excerpt:
- Nutrition and health claims shall be based on and substantiated by generally accepted scientific data.
A food business operator making a nutrition or health claim shall justify the use of the claim.
The competent authorities of the Member States may request a food business operator or a person placing a product on the market to produce all relevant elements and data establishing compliance with this Regulation.
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Additional information for health claims |
Record Keeping |
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- Description:
- For health claims, include the importance of a varied and balanced diet and healthy lifestyle, the required quantity and consumption pattern, and where applicable statements for persons who should avoid the food and warnings.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Foods bearing health claims, except generic advertising
- Checking responsibility:
- Food business operator
- Check method:
- Review labelling, presentation and advertising for the required additional information and warnings
- 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:
(a)
a statement indicating the importance of a varied and balanced diet and a healthy lifestyle;
(b)
the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect;
(c)
where appropriate, a statement addressed to persons who should avoid using the food; and
(d)
an appropriate warning for products that are likely to present a health risk if consumed to excess.
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Nutrition information for health claims |
Record Keeping |
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- Description:
- When making a health claim, provide the required nutrition information and, where applicable, state the amount of the relevant substance in the same field of vision.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Foods bearing health claims; relevant nutrients or other substances
- Checking responsibility:
- Food business operator
- Check method:
- Review labelling and the same field of vision for the required nutrition information and substance amounts
- 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. However, the information to be provided shall consist of information in Group 2 as defined in Article 4(1) of Directive 90/496/EEC.
In addition and as the case may be, the amount(s) of the substance(s) to which a nutrition or health claim relates that does not appear in the nutrition labelling shall also be stated in the same field of vision of the nutrition information
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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 applicant details, information on the substance or food, scientific studies, proprietary-data information where applicable, proposed wording and a summary.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Health claims subject to the authorisation procedure under Articles 15 to 18
- Checking responsibility:
- Applicant or food business operator
- Check method:
- Submit an application to the national competent authority with the required scientific documentation and information
- 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;
(b)
the nutrient or other substance, or the food or the category of food, in respect of which the health claim is to be made and its particular characteristics;
(c)
a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out with regard to the health claim and any other material which is available to demonstrate that the health claim complies with the criteria provided for in this Regulation;
(d)
where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;
(e)
a copy of other scientific studies which are relevant to that health claim;
(f)
a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;
(g)
a summary of the application.
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Requirements for comparative nutrition claims |
Record Keeping |
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- Description:
- Make comparative nutrition claims only between foods of the same category, state the difference in nutrient quantity or energy value, and use the same comparison quantity.
- Frequency:
- Event-triggered
- Check frequency:
- Event-triggered
- Products/Services:
- Foods bearing comparative nutrition claims
- Checking responsibility:
- Food business operator
- Check method:
- Compare with foods in the same category and state the difference for the same quantity of food
- 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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Additional statement for reduction of disease risk claims |
Record Keeping |
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- Description:
- For reduction of disease risk claims, state that the disease has multiple risk factors and that altering one risk factor may or may not have a beneficial effect.
- Frequency:
- Continuous
- Check frequency:
- Continuous
- Products/Services:
- Foods bearing health claims referring to reduction of disease risk
- Checking responsibility:
- Food business operator
- Check method:
- Review labelling, presentation and advertising for the required statement concerning multiple risk factors
- Rule set:
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- Source reference:
- Article 14(2)
- Source excerpt:
- In addition to the general requirements laid down in this Regulation and the specific requirements of paragraph 1, for reduction of disease risk claims 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 and that altering one of these risk factors may or may not have a beneficial effect.
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Notification of placing on the market and label model |
Reporting |
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- Description:
- Where required by a Member State, notify the competent authority of placing the food 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:
- Submit a model of the product label used 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