E.I.L. Vos

EU food safety regulation in the aftermath of the BSE crisis

Until the outbreak of the BSE crisis, many of the Communitys rules relating to food safety regulation were mainly created on an ad hoc basis and/or developed in the jurisprudence of the European Court of Justice. The BSE crisis, however, clearly demonstrated that where important political interests are at stake, this ad hoc approach is not sufficient to guarantee an effective and legitimate food safety policy and decision-making free from manipulation and capture. Therefore, the Commission has drastically revised its food safety policy. This article discusses the main elements of the new policy followed by the Commission. It analyses the new principles developed by both the Commission and the European Court of Justice. In conclusion it discusses the remaining challenges and gives some suggestions to further develop the emerging concept of Community food safety regulation.

The Precautionary Principle and the Uncertainty Paradox

In this article, it is argued that uncertainty and risk are intermingled and that this has severe consequences for risk regulation. First, uncertainty and risk are considered in the context of the precautionary principle from a theoretical point of view. On the basis of an interdisciplinary reflection, it is concluded that a paradox can be observed. Subsequently it will be investigated how this so‐called uncertainty paradox works out in practice. This will be done by analysis of the Pfizer case, situated at the EU level. In this case, that related to the use of antibiotics as a growth promoter in the production of meat, the precautionary principle was used as policy and legal principle. The analysis will detail the regulatory complexities that result from the contradictions in precautionary thinking. In conclusion suggestions will be advanced for regulatory reform in the broader sense, including the role of experts, and an interdisciplinary research agenda will be proposed.

Status of nutrition and health claims in Europe

Functional foods are closely associated with claims on foods. There are two categories of claims on foods: nutrition claims and health claims. Health claims on (functional) foods must be scientifically substantiated. In December 2006, the European Union published its Regulation 1924/2006 on nutrition and health claims made on foods. As concerns scientific evaluation, the EU-project PASSCLAIM resulted in a set of criteria for the scientific substantiation of health claims on foods. The European Food Safety Authority provides the scientific advise to the European Commission for health claims submitted under Regulation 1924/2006 and has hitherto published several hundreds of opinions on health claims, part of which are positive, part which are negative and a few with insufficient evidence. Antioxidant claims have been approved for the general function of vitamins but not for direct health effects in humans. Another issue with claims is consumer understanding. Consumers can hardly distinguish between graded levels of evidence, and they do make only little or no distinction between nutrition and health claims. Consumers understand nutrition and health claims different from scientists and regulators. Therefore, innovation in industry can readily proceed via approved nutrition claims and approved health claims. The market and the shelves in the stores will not be empty; rather they will look different in the years to come.

Wrestling with uncertain risks: EU regulation of GMOs and the uncertainty paradox

Dealing with uncertain risks is an important challenge. Uncertain risks need to be sharply distinguished from traditional, simple risks which can be calculated by means of statistics. Arguably current governance of uncertain risks tends to erode into organized irresponsibility, i.e., societys ill‐preparedness and inability to deal with surprises, negative consequences and/or long‐term impacts which are associated with uncertain risks, notwithstanding all institutions and procedures in place. In such cases, a particular pattern in risk regulation can be identified, the uncertainty paradox, which is an umbrella term for situations in which uncertainty is acknowledged, but the role of science is framed as one of providing certainty. This article highlights the need to further understand the uncertainty paradox by investigating actual decision‐making processes. Through case‐study research on EU GMO regulation this article examines how various actors actually deal with science, knowledge and uncertainty. Four mechanisms sustaining the uncertainty paradox are inferred: 1) uncertainty intolerance; 2) boundary work; 3) the inclination to equate uncertainty with risk; and 4) technocratic provisions. In conclusion, some suggestions are advanced as to how to break through the uncertainty paradox.

The Need for Change

The governance of food safety presents a formidable series of challenges , both in general and, more specifically, within the context of the European Union. 1 The purpose of this chapter is to outline and explore some of these challenges, bringing into focus the conceptual ideas upon which we may build in order to address them. The existing conditions that necessitate change in food safety governance arrangements within the EU will be discussed and related to potential procedural and institutional responses. As such, this chapter introduces and defines the terms used to describe the various stages in the governance process, as well as some of the specific problems encountered during each of these activities. These concepts will be further expanded upon in subsequent chapters describing a general framework for food safety governance within the European Union that can address the challenges discussed here.

Implementation of the nutrition and health claim regulation - the case of antioxidants.

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 EFSAs 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.

Antibiotics, the Precautionary Principle and the Cout in First Instance

This article comments upon the two judgments of the Court of First Instance (CFI) in the Pfizer and Alpharma cases of 11 September 2002. This case law is of importance as the Court for the first time explicitly addressed the precautionary principle and largely confirmed the elements laid down in the Commissions Communication on the Precautionary Principle of 2000. The case law can be criticized for the lenient implementation of the CFIs own requirements in relation to the application of the precautionary principle, such as having an as thorough risk assessment as possible and securing adequate guarantees for scientific objectivity. The decisions were a missed opportunity for the CFI to set high standards as regards the quality of the alternative scientific evidence relied on, in terms of excellence, independence and transparency.

Short review of sulphites as food additives.

Sulphites or sulphiting agents refer to sodium hydrogen sulphite, sodium metabisulphite, potassium metabisulphite, calcium sulphite, calcium hydrogen sulphite, and potassium hydrogen sulphite. As food additives, they are widely used by the food industry with a variety of commercial uses in food and beverages. Sulphites are effective bleaching agents, antimicrobials, oxygen scavengers, reducing agents, and enzyme inhibitors. Wine, beer, dehydrated fruits and vegetables, jam, juice, sugar, processed potatoes, seafood, meat and baked products are some of the food categories in which sulphites are added. S ulphites have been implicated in various health related issues. Asthmatic reactions and some antinutriti onal consequences such the degradation of thiamine (vitamin B 1 ) are adverse reactions associated with sulphites. In many countries, sulphites have been regulated. Sulphites are generally recognized as safe in the USA with some exceptions when using in raw fruits and vegetables. In the European Union sulphites are also controlled, and the permitted amount varies according to the food product.

Short review of extracts of rosemary as a food additive.

Extracts from Rosmarinus officinalis L., more commonly known as rosemary, have been approved for use in the EU as food additive E932 under Regulation 1333/2008 of the European Parliament and the Council. Rosemary extracts are currently widely used to increase shelf life of food products. Rosemary extracts are characterised by two reference antioxidant compounds, carnosol and carnosic acid . T his characterization allows for difference s in rosemary ext racts. Four approved production methods, as described by Commission Regulation 231/2012, produce rosemary extracts with different compositions and antioxidant activity. This results in difficulties to compare scientific data and to assess the safety of approved rosemary extracts. Based on unpublished studies for each of the four approved extract types, EFSA concluded that “the proposed uses and use levels would not be of safety concern“. Yet, gaps in knowledge still exist for the approved extracts as man y different rosemary extracts are used in scientific research.

Short review of Calcium Disodium ethylene diamine tetra acetic acid as a food additive.

Calcium disodium ethylenediaminetetraacetate (Calcium Disodium EDTA, C10H12CaN2Na2O8.2H2O) is a derivative of EthylenediamineTetraacetic Acid and is an approved food additive (E385). It is used as preservative, sequestrant, flavouring agent, and colour retention agent in foods. As a drug it is used for the reduction of blood and mobile depot lead in the treatment of acute and chronic lead poisoning. Calcium Disodium EDTA is very poorly absorbed from the gastrointestinal tract following ingestion. The compound is metabolically inert and no accumulation in the body has been found. Acute, short-term, sub chronic and chronic toxicity studies carried out with Calcium Disodium EDTA in laboratory animals found that the compound is nephrotoxic at high doses. In similar high doses, application of Calcium Disodium EDTAcan result in complexation of zinc ions, thus interfering with the zinc homeostasis and causing developmental toxicity. Mini Review Article European Journal of Nutrition & Food Safety, 4(4): 408-423, 2014 409 No evidence exists suggesting the compound exerts genotoxic or carcinogenic effects. Overall, Calcium Disodium EDTAseems to be safe for use as a food additive, as the noted toxic doses are higher than can be achieved via the addition of Calcium Disodium EDTA to food. However, human data is limited and the gross of available (human and animal) data, as well as the ADI, stems from several decades ago. Caution should also be taken when Calcium Disodium EDTA is administered as treatment for lead poisoning, as the exposure increases greatly. Until 2020, EFSA will carry out new risk assessments, and subsequently the Commission will revise the list of food additives and the conditions of use specified therein. The deadline for food additives other than colours and sweeteners is 31 December 2018, which seems appropriate regarding the non-acute need for reevaluation of Calcium Disodium EDTA as food additive.