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The search returned 6 results.

Designing Human Intervention Studies for Scientific Substantiation of Health Claims – How EFSA Thinks journal article

Steffen Jakobs, Andreas Hahn

European Food and Feed Law Review, Volume 14 (2019), Issue 5, Page 412 - 429

According to Regulation (EC) 1924/2006, health claims made on foods need an authorisation and the effect must be ‘established by generally accepted scientific data’. The scientific assessment on applications for health claims is the responsibility of the European Food Safety Authority (EFSA). Thus, the Authority plays the crucial role in the scientific acceptance or rejection of health claims. In accordance with Regulation (EC) 353/2008, in order to substantiate a health claim, data from human studies are required to prove the relationship between the consumption of the food/food constituent and the claimed effect. In this context, EFSA considers double-blind randomised controlled trials in humans to be the gold standard. So far, the Authority has not published an exclusive guidance for reporting of human intervention studies in order to present transparent and consistent criteria for these studies. Thus, clear and concrete guidelines for adequately performing such studies are missing, which represents a general problem for applicants. Therefore, based on an evaluation of all scientific opinions on claims according to Article 13, this paper addresses key factors that EFSA requests to report on the design, conduct and statistical analysis of human intervention studies with foods or food constituents for scientific substantiation of health claims. It also shows that EFSA’s work often is neither transparent nor consistent. Keywords: Health claims; EFSA; Food labelling; Human intervention studies; RCTs.


The Labelling of Nanomaterials under EU Law, with a Particular Focus on France journal article

Patrick Coppens, Francesco Planchenstainer

European Food and Feed Law Review, Volume 14 (2019), Issue 2, Page 152 - 159

The use of nanomaterials in foods is one of the emerging areas for innovation that is addressed by EU Food Law. New applications of nanomaterials require pre-market authorisation under the Novel Foods Regulation (EU) 2015/2283 or, in the case of food additives, under Regulation (EC) 1333/2008. Under the labelling provisions (Regulation (EU) 1169/2011) the presence of engineered nanomaterials needs to be indicated in the labelling of foods. These regulations apply in all EU Member States. Recently, however, controversy has arisen, in particular in France, with a seemingly diverging application of these laws and a legal initiative to ban the use of a food additive (E171 – Titanium Dioxide) based on safety concerns because of the presence of nanoparticles. The paper describes the background and provides a legal analysis of the consistency of these developments with EU legal principles. Keywords: EU Commission; France; Labelling; Novel foods; Food additives; Nanomaterials; Precautionary principle; Titanium dioxide.


Quantitative Allergen Labelling journal article

René Crevel

European Food and Feed Law Review, Volume 13 (2018), Issue 1, Page 2 - 8

Food allergy is now fully accepted as an important food safety issue and specific legislation exists in jurisdictions covering close to half the world’s population. This recognition implies a need to manage the risk it poses alongside longer-established food safety risks such as microbiological, physical or other chemical food safety risks. However, management of food allergy risks still suffers from the historical lack of a generally-accepted risk assessment approach, founded on a quantitative basis. The uncertainties over the health risk posed by unintended allergen presence (UAP) felt by many actors in this field is reflected in particular by the extensive and largely unmanaged use of precautionary allergen labelling (PAL) to mitigate it. Intensive work involving multiple stakeholders over many years has helped to characterise this health risk quantitatively and build tools to assess it. A high degree of agreement among those stakeholders now exists within Europe in particular about the possibility and desirability of applying the approaches developed. Furthermore European Union legislation already contains provisions that enable the development and implementation of a framework for managing the risks from UAP to the benefit of all parties. This paper discusses the context and evolution of quantitative allergen labelling and how it can effectively support food safety policy objectives.


Vegetarian and Vegan Products - Labelling and Definitions journal article

Felix Domke

European Food and Feed Law Review, Volume 13 (2018), Issue 2, Page 102 - 107

As dietary habits throughout Europe are changing, more and more consumers turn towards plant-based lifestyles. The range of vegetarian products is increasing accordingly. However, crucial food labelling questions remain to be solved. This includes the definition of the terms “vegan” and “vegetarian” for food labelling purposes and questions concerning the use of certain sales denominations for meat and dairy alternatives. This article explores both issues from the perspective of the European Vegetarian Union (EVU) and gives insights into the legal and political situation.


Innovation before Regulation or Vice Versa? journal article

An Analysis of the European Court of Justice Approach to Advance in Mechanically Separated Meat Production

Artur Nowak-Far

European Food and Feed Law Review, Volume 12 (2017), Issue 4, Page 310 - 320

EU regulation hardly follows the technological advancements in various reduced meat products (RMP) markets. The European Court of Justice’s (ECJ) jurisprudence (in addition to the Commission’s soft law) has an important role to play to fill out regulatory gaps which arise as a result of an application of fairly generic EU rules to these technological advancements. In its approach to classification problems arising with respect to various RMP, the ECJ quite adequately identifies them as agnation matters. Therefore, the Court adopts simultaneously various criteria for classification (especially emphasising safety measures) drawing from all relevant legal sources pertaining to RMP and successfully pursuing their reconciliation. This approach makes the ECJ disinclined to accept novel technologies of RMP processing as ones leading to the development of products distinguishable from mechanically separated production (MSP) whenever rough criteria for MSP definition (under Regulation 853/2004/EC) are met. This means that a distinctive outer appearance would not suffice to disqualify the product as MSP. Moreover, RMP testing advancements (indicating that calcium content should be used as a reliable marker for MSP) make it even less likely that product appearance alone would suffice in the future to qualify such a product as minced meat.


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