E-Book, Englisch, 124 Seiten
EFFoST Critical Reviews #3
E-Book, Englisch, 124 Seiten
ISBN: 978-0-12-420214-6
Verlag: Elsevier Reference Monographs
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)
Provides comparative study of nanofood regulations in order to guide regulation development in this rapidly expanding marketIncludes both case-by-case examples and more broad-based insightsProvides models for regulation specifically for regulating nanotechnology as applied to food
Wageningen University, Wageningen, The Netherlands
Autoren/Hrsg.
Weitere Infos & Material
Chapter 2 Requirements for Food Safety Regulation
Fundamental principles of food safety governance include the principles of safety (no harm) and the principle of science-based decision making. In nanofoods, absence of data and inconclusiveness of risk assessment pose challenges to science-based decision making. Here authorization requirements and the precautionary principle may play a role. To be able to adapt to uncertainties and increasing understanding, the regulatory system needs to be responsive, the private sector needs to be responsible and the public sector needs to be communicative. Keywords
Principle of safety; science-based decision making; precautionary principle; responsive regulation 2.1 Introduction
This chapter describes how the three elements of principles-based regulation work together in food safety governance. Section 2.2 introduces the first element consisting of the setting of broad-based standards in food safety governance. Section 2.3 elaborates on two elements of principles-based regulation. It shows how risk analysis puts flesh on the bones of these principles, thereby determining the regulatory outcome of these standards. Section 2.4 elaborates how the need to require scientific data primarily from private risk assessors increases responsibility of private businesses. 2.2 Fundamental Principles of Food Safety Governance
There are two main principles in food safety governance, which qualify for general application: the principle of safety (Section 2.2.1) and the principle of science-based decision making (Section 2.2.2). 2.2.1 The Principle of Safety
The main principle of trade in food markets is the prohibition of marketing of unsafe foods. In the EU for example, to this end, Article 14 (1) of Regulation (EC) 178/2002 laying down the general principles and requirements of Food Law (hereinafter General Food Law) stipulates that: Food shall not be placed on the market if it is unsafe. Other legislation such as the Canadian Food and Drugs Act1 or the US-American Federal Food Drug and Cosmetic Act2 do not carry such an explicit overall command, but contain a catalogue of regulatory measures designed to ensure the safety of foods. Article 2 of the SPS Agreement3 obliges Members of the WTO to ‘ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, (…)’. From the Codex General Standard on Food Additives can be deduced a general principle of no harm. Only those substances may be added to food for which it has been demonstrated that they can be ingested daily over a lifetime without an appreciable health risk; that is to say that have been assigned an acceptable daily intake (ADI).4 Ensuring safety of food is a joint responsibility of the private sector businesses that produce and market food and food ingredients and the government bodies that set and enforce standards to ensure food safety. Under most national systems in the developed world, private businesses have a general duty not to market unsafe foods and food components, with governments being empowered to act to remove unsafe foods from commerce and to take action against private businesses that do not conform to required food safety practice. Ultimately it is up to the regulators to establish an appropriate level of protection. 2.2.2 The Principle of Science-Based Decision Making
Whenever one has to determine the safety of foods, it has to be based on a scientific assessment. In the EU Article 1(2) General Food Law stipulates that a ‘strong science base’ needs to underpin any ‘decision making in matters of food and feed safety’. Likewise, Article 2(2) of the SPS Agreement requires ‘that any sanitary or phytosanitary measure’ of WTO Members ‘is based on scientific principles and is not maintained without sufficient scientific evidence (…)’. Risk analysis is the generally accepted methodology through which science contributes to the regulation of food safety. It encompasses three steps: risk assessment, risk communication and risk management. The Codex Alimentarius and an increasing number of countries such as the USA, the EU, Australia/New Zealand, Canada and Japan draw from the responsibility of private businesses for food safety the conclusion that sponsors of new substances added to food must provide the scientific data needed for risk assessment as a basis for risk management decisions regarding market access of the substance at issue. 2.3 Risk Analysis as a Method to Determine the Regulatory Outcome
Broad principles require substantiation in order to make them work for everyday practice in regulatory regimes. According to the principle of science-based decision making, in food law such a substantiation has to be based on a scientific risk analysis. The concept of risk analysis has been elaborated in the Codex Alimentarius Procedural Manual5 and was taken up by a number of laws around the world. Risk analysis should follow a structured approach comprising three distinct but closely linked components: risk assessment (Section 2.3.1), risk management (Section 2.3.2) and risk communication (Section 2.3.3).6 Depending on the context in which risk analysis is applied, two different types of question are asked from science:7 1. to identify risks and/or 2. to exclude risks. As we will see below, the type of question at issue has an impact on the burden of proof and on the consequences of inconclusive risk assessment. The WTO SPS Agreement seems to regard risk analysis as the responsibility of the authority that wishes to create a trade barrier. In such a situation science is asked to positively identify a risk that is then taken care of by the protective measure. Under premarket approval schemes introduced here below, the question to science is not to identify risks but to exclude them. Only if proof of safety is provided, will the product at issue be allowed to the market.8 2.3.1 Risk Assessment
The Codex Procedural Manual defines risk assessment as a scientifically based process consisting of four steps: (i) hazard identification, (ii) hazard characterisation, (iii) exposure assessment and (iv) risk characterisation.9 In international regulatory frameworks, three joint FAO and WHO committees undertake risk assessment: the joint FAO/WHO Expert Committee on Food Additives (JECFA); the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and the Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA). They advise on maximum (residue) limits for food additives, pesticides and pathogens and on other scientific issues regarding food safety. These three risk assessors are independent from the risk managers. Furthermore, Codex Principles for risk analysis for application by governments calls for the separation of risk assessment and risk management functions to the extent practicable. In the EU, the European Food Safety Authority (EFSA) is charged with risk assessment. Risk management is the responsibility of political bodies such as the European Commission (EC), the Council, the European Parliament and the Member States. EFSA is independent from these authorities but itself holds no powers of risk management. In the USA by contrast, both scientific risk assessment and (administrative and regulatory) risk management are the responsibility of the Food and Drug Administration (FDA) or – for certain types of foods of animal origin – the Department of Agriculture (USDA). In other countries varying degrees of separation of risk assessment and risk management functions are observed. Apparently, the necessity of independence of risk assessment is open to debate. This model for risk assessment is considered by most experts as adequate to assess the risks related to foods produced using nanotechnologies. However, it is also widely recognised that many gaps exist in the actual knowledge and understanding of the potential hazards deriving from nanotechnologies applied in the agri-food sector and that there is a need for additional tools to support risk assessment of nanomaterials.10 In particular, the association between toxic effects and dose, as well as the characterisation of nanoparticles, are probably the two most urgent issues awaiting resolution for a better understanding of risk potentially deriving from ENMs. At present, a case-by-case approach to risk assessment of ENMs is being taken. However, risk assessment authorities must prioritise research to generate the required data to fill existing knowledge gaps and develop comprehensive guidelines for risk assessment of ENMs. One of the main recommendations of the 2009 FAO/WHO Expert Meeting on the Application of Nanotechnologies11 was to consider the use of a tiered risk assessment approach for application of nanotechnologies to food and feed. It should consist of an initial screening level, to characterise the material and to estimate toxicity and exposure or dose–response relationships. It should subsequently progress through more refined and data-intensive tiers, if appropriate. Implementation of such an approach will result in increased knowledge of the relationships between physicochemical characteristics and biological interactions. Ultimately this may enable the prioritisation of types or classes of materials where additional data are...
