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11.2.  Protection of health and physical safety in the EU

    The European Community turned its attention to the physical safety of consumers in the 1970s. But for many years, efforts in this field were overshadowed by other common policies, notably the agricultural one and that of removing technical barriers to trade. This was particularly true on the alignment of legislation on cosmetics [Regulation 1223/2009, last amended by Regulation 2016/1198] and that on the classification, packaging and labelling of dangerous preparations [Directive 1999/45]. These legislations, however, adapted over the years to technical progress, have gradually become more protective of human health. Other legislative acts aim directly at this objective, notably the Regulations concerning food additives [Regulation 1333/2008, last amended by Regulation 2016/324], food enzymes [Regulation 1332/2008] and flavourings [Regulation 1334/2008, last amended by Regulation 2016/55] authorised for use in foodstuffs intended for human consumption [Regulation 1331/2008] and the Directive on measures to monitor certain substances and residues thereof in live animals and animal products [Directive 96/23].

    The accident at the Chernobyl nuclear power plant in April 1986 gave the European Community an opportunity to complete its legislation on radioactive contamination. In addition to ad hoc measures adopted in order to coordinate national measures covering agricultural produce [Recommendation 86/156] and definition of conditions under which agricultural produce originating in third countries could be imported [Regulation 3955/87], the Council adopted a Regulation setting maximum permitted levels of radioactive contamination of foodstuffs and of feeding stuffs following a nuclear accident or any other case of radiological emergency [Regulation 2016/52].

    The effort to complete the internal market proved the effective trigger of a genuine policy to protect the health and physical safety of consumers. In the 1980s the EC/EU placed the wellbeing of its citizens high on its list of priorities by adopting general legislation guaranteeing the safety of individuals in their capacity as users of products, regardless of the origin of the latter. This is the aim of a Directive on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers [Directive 87/357]. This Directive prohibits the marketing, import and either manufacture or export of dangerous imitations of foodstuffs. Such products can be withdrawn from the market by a Member State and the Commission and the other Member States are informed of their existence.

    A major Directive in the context of the single market was adopted in 1988 dealing with toy safety [Directive 2009/48, last amended by Directive 2014/79]. It sets the basic safety requirements that must be met by all toys manufactured in the EU or imported from third countries. The European standardisation committees then adopt harmonised standards and manufacturers respecting these are covered by a presumption that their toys meet the basic safety requirements defined in the Directive [see section 6.2.3]. This Directive consequently promotes the free movement of goods while encouraging the manufacture of high-quality danger-free toys for the Union's children.

    Since it is difficult to adopt European legislation for every product, it is necessary to establish at European level a general safety requirement. This general legal instrument is provided by a Directive on general product safety [Directive 2001/95]. The purpose of this Directive is to ensure that products placed on the market, which are intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, are safe. Producers are obliged to place only safe products on the market, conforming to the specific rules of national law of the Member State in whose territory the product is marketed drawn up in conformity with the Treaty and in accordance with Directive 98/34 laying down a procedure for the provision of information in the field of technical standards and regulations [see section 6.2.2]. Distributors are required to act with due care to help to ensure compliance with the applicable safety requirements, in particular by not supplying products which they know or should have presumed, on the basis of the information in their possession and as professionals, do not comply with those requirements. Where producers and distributors know or ought to know that a product that they have placed on the market poses risks to the consumer they must immediately inform the competent authorities of the Member States thereof. Member States must ensure that producers and distributors comply with their obligations, establish or nominate authorities competent to monitor the compliance of products with the general safety requirements and lay down the rules on penalties applicable to infringements of the national provisions adopted. The Commission must promote and take part in the operation in a European network of the authorities of the Member States competent for product safety. This network must be coordinated with other European procedures, in particular the Rapid Information System (RAPEX), which is described in Annex II of the directive and is essentially aimed at a rapid exchange of information in the event of a serious risk.

    Regulation 178/2002 lays down the general principles and procedures in matters of food law and food safety and establishes the European Food Safety Authority [Regulation 178/2002]. Whilst ensuring the effective functioning of the internal market, it aims at ensuring a high level of protection of human health and consumers' interest in relation to food, taking into account in particular the diversity in the supply of food including traditional products. It establishes common principles and responsibilities, the means to provide a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food and feed safety. The European Food Safety Authority must provide scientific advice, independent information and scientific and technical support for the European legislation and policies in all fields which have a direct or indirect impact on food and feed safety.

    Union legislation governing food hygiene [Regulation 852/2004], health issues related to the marketing of products of animal origin [Directive 2004/41] and the organisation of official controls on such products has been recast in 2004 [Regulation 854/2004]. Henceforth, a distinction is made between aspects of food hygiene and matters to do with animal health and official controls, thus providing scope for defining clearly the responsibilities of food business operators and the competent authorities in the Member States. A key point of the new legislation is that every operator involved in the food chain will bear primary responsibility for food safety, with a single, transparent hygiene policy being applicable to all foodstuffs and all operators (from the farm to the table), together with effective instruments to guarantee food safety and manage any future crisis in the sector. Administrative measures with criminal sanctions and financial penalties may be imposed on any Member State which fails to comply with European feed and food law [Regulation 882/2004, last amended by Regulation 2015/525]. In 2005, rigorous European measures were taken for the control of avian influenza, including provision of contingency plans in the event of human contamination [Directive 2005/94, consolidated version 03.09.2008].

    The food safety policy of the European Union is based on the precautionary principle. This principle is an integral part of a structured approach to risk analysis based on assessment, management and communication of risk. In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Union may be adopted, pending further scientific information for a more comprehensive risk assessment. Indeed, according to the Court of Justice, when there is uncertainty regarding the risk to human health or safety, the European institutions are empowered to take protective measures without having to wait until the reality and seriousness of those risks becomes fully apparent [Cases C-180/96 and C-157/96].

    In accordance with the precautionary principle, a Directive aims at monitoring the deliberate release into the environment and on the placing on the market of genetically modified organisms (GMOs) as or in products [Directive 2001/18 and Decisions 2002/811, 2002/812 and 2002/813]. Products containing GMOs must be clearly labelled and the public must be informed and consulted prior to the release and placing on the market of GMOs and products containing GMOs. Member States must establish public registers of all locations where GMOs are grown and have agreed deadlines for phasing out antibiotic resistance markers in GMOs which could have adverse effects on human health and the environment. Genetically modified micro-organisms may be used solely under conditions of contained use [Directive 2009/41]. A Regulation provides a framework for the traceability of products consisting of or containing GMOs, and food and feed produced from GMOs, with the objectives of facilitating accurate labelling, monitoring the effects on the environment and, where appropriate, on health, and the implementation of the appropriate risk management measures including, if necessary, withdrawal of products [Regulation 1830/2003]. Another Regulation lays down Union procedures for the authorisation and supervision of genetically modified food and feed and lays down provisions for the labelling of genetically modified food and feed [Regulation 1829/2003].

    According to the Court of First Instance the precautionary principle  can be applied only where there is a risk, notably for human health, which had not yet been conclusively demonstrated, but it cannot be based on unverified conjecture [Cases T-13/99 and T-70/99]. Before any preventive measures are taken, the competent public authority has to conduct a risk assessment with two complementary components: a scientific component (as thorough a scientific risk assessment as possible taking account notably of the urgency of the situation) and a political component (risk management), with the public authority determining the desired level of protection and consequently deciding on an appropriate measure given the level of risk it has determined. "Risk" thus constitutes a function of the probability that use of a product or a procedure can adversely affect human health. "Hazard" ("danger") is, in this context, commonly used in a broader sense and describes any product or procedure capable of having an adverse effect on human health.

    Taking account of the bovine spongiform encephalopathy (BSE) experience [see sections 5.1.3 and 21.4.2], animal-health rules govern the placing on the market and importation from third countries of products of animal origin, with a view to preventing the spread of animal diseases [Directive 2002/99]. Other rules are applicable to the collection, transport, storing, handling, processing and use or disposal of animal by-products and derived products, in order to protect the safety of the food and feed chain [Regulation 1069/2009, last amended by Regulation 2015/9]. They prohibit the recycling of dead animals and condemned animal material into the feed chain. The only raw material allowed to be used for the production of animal feed is material derived from animals declared fit for human consumption. More generally, a regulation lays down requirements for feed hygiene, so as to ensure a high level of consumer protection with regard to food and feed safety [Regulation 183/2005].

    A directive aims to approximate the laws of the Member States with a view to maintaining both a high level of public health protection and the free circulation of products marketed in the European Union as foods containing concentrated sources of nutrients (vitamins and minerals) and presented for supplementing the intake of those nutrients from the normal diet [Directive 2002/46]. It establishes specific rules on labelling and criteria for fixing the maximum quantities of vitamins and minerals in these products. Harmonised rules regulate the addition of vitamins and minerals to foods and the use of certain other substances or ingredients containing substances other than vitamins or minerals that are added to foods or used in the manufacture of foods [Regulation 1925/2006]. A Regulation defines a legislative framework geared to authorising the use of nutrition and health claims in the labelling, presentation and advertising of foods, under strict conditions, following an independent scientific assessment and European authorisation [Regulation 1924/2006]. Foods and food ingredients treated with ionising radiation [see sections 13.5.7 and 19.2.3] are also subjected to European checks [Directive 1999/2].

    After the BSE or "mad-cow" crisis of 1996, the Commission set up advisory Scientific Committees, made up of distinguished scientific experts, to provide sound scientific advice and coordinate the work of the various sector-specific scientific committees in the field of consumer health. Three scientific committees on consumer safety and environmental risks and a Pool of Scientific Advisors on Risk Assessment are required to provide sound and timely scientific advice for Commission proposals, decisions and policy relating to consumer safety, public health and the environment [Decision 2008/721]. The European "Food and Veterinary Office", has responsibility for monitoring the observance of veterinary and plant-health legislation and food hygiene rules both within the European Union and in countries which provide it with foodstuffs. However, recommendations issued by the scientific committees are not always taken into consideration by the Member States [COM/98/598]. On February 2006, the Commission established interim protection measures in relation to suspected cases of highly pathogenic avian influenza in wild birds in the European Union [Decision 2006/115, repealed by decision 2006/563].

    Thanks to the European system of rapid information exchange on dangers arising from the use of consumer products (RAPEX), the Member States and the Commission can take the necessary urgent steps when it becomes known that a particular consumer product is a source of immediate and serious danger to consumer health and physical safety. Managed by the Commission, the system has permitted the withdrawal from the market of several dangerous products, particularly foodstuffs. Early-warning systems cannot work properly, however, if the Member States do not apply the appropriate measures fully and in good time when a risk arises, as was the case of Belgium which infringed European procedures by not informing the Commission and the other Member States immediately that dioxin had been found in foodstuffs and in animal feed in June 1999 [see section 5.1.3]. The programme of European action in the field of public health aims, among other things, to enhance the capability of responding rapidly and in a coordinated fashion to threats to health [Regulation 282/2014 , see section 13.5.8].

    Physical safety and health of consumers is integrated in other common policies, particularly: the agricultural policy (definition of dairy products and imitation dairy products, regulation of organic products, veterinary problems, promotion of high quality products and, in general, food policy) [see sections 5.1.3 and 21.4.2]; research policy (food quality and safety) [see section 18.2.6]; the process of completing the internal market (machinery, foodstuffs, construction materials) [see section 6.2]; and public health policy (measures to combat smoking, etc.) [see section 13.5.8].

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    Your roadmap in the maze of the European Union.

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