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PASSCLAIM - Synthesis and review of existing processes

Richardson, DP ; Affertsholt, T ; Asp, Nils-Georg LU ; Bruce, A ; Grossklaus, R ; Howlett, J ; Pannemans, D ; Ross, R ; Verhagen, H and Viechtbauer, V (2003) In European Journal of Nutrition 42(Suppl. 1). p.96-111
Abstract
Several approaches to the use of health claims on foods have been made around the world, and the common theme is that any health claim will require scientific validation and substantiation. There is also broad consensus that any regulatory framework should protect the consumer, promote fair trade and encourage innovation in the food industry. This paper is based on a critical evaluation of existing international approaches to the scientific substantiation of health claims, with a view to identifying common new ideas, definitions, best practice and a methodology to underpin current and future developments. There is a clear need to have uniform understanding, terminology and description of types of nutrition and health claims. Two broad... (More)
Several approaches to the use of health claims on foods have been made around the world, and the common theme is that any health claim will require scientific validation and substantiation. There is also broad consensus that any regulatory framework should protect the consumer, promote fair trade and encourage innovation in the food industry. This paper is based on a critical evaluation of existing international approaches to the scientific substantiation of health claims, with a view to identifying common new ideas, definitions, best practice and a methodology to underpin current and future developments. There is a clear need to have uniform understanding, terminology and description of types of nutrition and health claims. Two broad categories were defined: Nutrition Claims, i.e. what the product contains, and Health Claims, i.e. relating to health, well-being and/or performance, including well-established nutrient function claims, enhanced function claims and disease risk reduction claims. Such health claims relate to what the food or food components does or do. The categories of health claims are closely and progressively related and are, in practice, part of a continuum. Provision is also made for "generic" or well-established, generally accepted claims and for "innovative" or "product-specific" claims. Special attention was paid to reflect the health-promoting properties of a food or food component in such a way as to facilitate the making of risk reduction claims outside the medical scope of the term prevention. The paper sets out basic principles and guidelines for communication of health claims and principles of nutritional safety. The main body of the work examines the process for the assessment of scientific support for health claims on food and emphasises an evidence-based approach consisting of: Identification of all relevant studies exploring the collection of evidence, data searches, the nature of the scientific evidence, sources of scientific data (including human intervention studies, human observational studies, animal studies and in vitro studies, and the use of biomarkers in human studies Evaluation of the quality of individual studies to ensure good experimental design and interpretation Interpretation of the totality of evidence to apply scientific judgement to interpret the weight of evidence as a whole Assessment of significant scientific agreement on a case-by-case basis to agree within the relevant scientific community that an association between a food or a food component and a health benefit is valid. Annexes include an international comparison of regulatory approaches to health claims, suggestions for the documentation and presentation of evidence, and a procedure for reviewing the evidence. (Less)
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author
; ; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
scientific substantiation, health claims, definitions
in
European Journal of Nutrition
volume
42
issue
Suppl. 1
pages
96 - 111
publisher
Springer
external identifiers
  • wos:000228563100005
  • scopus:0642347884
ISSN
1436-6215
DOI
10.1007/s00394-003-1105-z
language
English
LU publication?
yes
additional info
The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Applied Nutrition and Food Chemistry (011001300)
id
9f587509-26bc-4a77-a17c-59d6c0a4533c (old id 245804)
date added to LUP
2016-04-01 12:05:17
date last changed
2023-09-01 18:51:05
@article{9f587509-26bc-4a77-a17c-59d6c0a4533c,
  abstract     = {{Several approaches to the use of health claims on foods have been made around the world, and the common theme is that any health claim will require scientific validation and substantiation. There is also broad consensus that any regulatory framework should protect the consumer, promote fair trade and encourage innovation in the food industry. This paper is based on a critical evaluation of existing international approaches to the scientific substantiation of health claims, with a view to identifying common new ideas, definitions, best practice and a methodology to underpin current and future developments. There is a clear need to have uniform understanding, terminology and description of types of nutrition and health claims. Two broad categories were defined: Nutrition Claims, i.e. what the product contains, and Health Claims, i.e. relating to health, well-being and/or performance, including well-established nutrient function claims, enhanced function claims and disease risk reduction claims. Such health claims relate to what the food or food components does or do. The categories of health claims are closely and progressively related and are, in practice, part of a continuum. Provision is also made for "generic" or well-established, generally accepted claims and for "innovative" or "product-specific" claims. Special attention was paid to reflect the health-promoting properties of a food or food component in such a way as to facilitate the making of risk reduction claims outside the medical scope of the term prevention. The paper sets out basic principles and guidelines for communication of health claims and principles of nutritional safety. The main body of the work examines the process for the assessment of scientific support for health claims on food and emphasises an evidence-based approach consisting of: Identification of all relevant studies exploring the collection of evidence, data searches, the nature of the scientific evidence, sources of scientific data (including human intervention studies, human observational studies, animal studies and in vitro studies, and the use of biomarkers in human studies Evaluation of the quality of individual studies to ensure good experimental design and interpretation Interpretation of the totality of evidence to apply scientific judgement to interpret the weight of evidence as a whole Assessment of significant scientific agreement on a case-by-case basis to agree within the relevant scientific community that an association between a food or a food component and a health benefit is valid. Annexes include an international comparison of regulatory approaches to health claims, suggestions for the documentation and presentation of evidence, and a procedure for reviewing the evidence.}},
  author       = {{Richardson, DP and Affertsholt, T and Asp, Nils-Georg and Bruce, A and Grossklaus, R and Howlett, J and Pannemans, D and Ross, R and Verhagen, H and Viechtbauer, V}},
  issn         = {{1436-6215}},
  keywords     = {{scientific substantiation; health claims; definitions}},
  language     = {{eng}},
  number       = {{Suppl. 1}},
  pages        = {{96--111}},
  publisher    = {{Springer}},
  series       = {{European Journal of Nutrition}},
  title        = {{PASSCLAIM - Synthesis and review of existing processes}},
  url          = {{http://dx.doi.org/10.1007/s00394-003-1105-z}},
  doi          = {{10.1007/s00394-003-1105-z}},
  volume       = {{42}},
  year         = {{2003}},
}