Implementation of the nutrition and health claim regulation – The case of antioxidants

Abstract

This article analyses the consequences of the implementation of the nutrition and health claim regulation in the field of food products containing antioxidants or food products claiming antioxidant activity. To this end, it first examines the origin and creation of the regulation and the involvement of EFSA in assessing scientific substantiation of health claims. Three criteria are regarded as critical in EFSA's opinions on the scientific substantiation of a health claim: the claimed effect (i) is well defined; (ii) is a clear beneficial physiological effect; and (iii) shows a cause effect relationship with the consumption of the food or functional ingredient. These criteria have implications for the research requested to substantiate health claims, although these implications do not all seem to fit nutrition research as it is currently executed. Looking at antioxidants, the complexity of the mechanisms and actions of antioxidants is not recognised by the criteria used to evaluate proposed health claims, nor by the methodologies used to assess the effects of antioxidants. These criteria should be adjusted with novel scientific insights after consulting stakeholders.

Stakeholders’ perception of the nutrition and health claim regulation

“…Currently, the EC authorized 233 claims (European Commission, 2012). EFSA considered nearly all proposed article 13.1 claims on antioxidants were not substantiated satisfactorily, leading the EC to decline these claims (de Boer et al, 2014;European Commission, 2013). Only eight claims on antioxidant activity received a positive advise and were subsequently authorized by the EC, viz.…”

“…seven claims on vitamins and minerals, one claim on olive oil polyphenols (European Commission, 2013). Positive opinions from EFSA on watersoluble tomato concentrate (NDA Panel EFSA, 2009) and on cocoa flavonoids (NDA Panel EFSA, 2012) are not taken into account here, since the claimed health benefits of these products are not regarded as consequence of antioxidants as the active ingredient (de Boer et al, 2014).…”

Supplements in the European Union: An Analysis of Health Claims Related to Articular Joint Health

“…For these claims, a beneficial effect can also relate to the improvement of joint function. Considering the analysis in the broader perspective of the 2822 claims evaluated up to April 2, we find that in many cases the NDA Panel did not consider the effect claimed in applications as beneficial to human health, such as in claims related to antioxidants [4,58] and probiotics [59,60]. and relative acts, the evidence of 'traditional use' is insufficient to prove the substantiation of claims on botanicals and others miscellaneous bioactive substances.…”

¿Bueno para la salud? Un análisis de los requisitos de sustanciación científica en la regulación europea de las declaraciones de salud

“…[16][17][18][19] Richardson 17 y Flynn 9 presentan algunas de las razones más frecuentes aducidas para rechazar las peticiones:…”

“…16,17,19 La aplicación de estos criterios ha producido casos como el siguiente, analizado por de Boer y colaboradores: 16 la EFSA ha informado positivamente declaraciones relativas a, por ejemplo, el cobre y los polifenoles del aceite de oliva, por ser componentes bien caracterizados y medibles, rechazando al mismo tiempo otras relativas a la miel y los polifenoles de frutas, verduras y zumos procesados por no estar suficientemente caracterizados y ser difíciles de medir.…”