Directives defective products

A new additive dose method is proposed to obtain the age directly without extrapolating the growth curve.1115 The experimental growth curve at the artificial irradiation dose rate gives simply the defect production efficiency (G-value) from the initial growth and the interaction distance, d, between spins from the saturation behaviour. The latter involves the effect of magnetic dipolar and exchange interactions of similar and dissimilar spins and also destabilization of a spin in a distorted area by a local lattice distortion. 

Pesticides are frequently used to control insects, rodents, weeds, microbes, or fungi. In addition, they help farmers provide an affordable and plentiful food supply. Pesticides are also used in other settings, such as homes and schools, to control pests as common as cockroaches, termites, and mice. Pesticides pose significant risks to human health and the environment, when people do not follow directions on product labels or use products irresponsibly. For example, people might use pesticides when they are not really needed, apply too much, or apply or dispose of them in a manner that could contaminate water or harm wildlife. Even alternative or organic pesticides can have these unintended consequences if not used correctly (EPA, 2003 c). There is abundant scientific evidence of the risks toxic pesticides pose to human health. More worrisome from a public health perspective are chronic health effects such as cancer, infertility, birth defects, miscarriage, and negative effects on the brain and nervous system. 

The GMP Directive requires each manufacturer to have a system for complaints and product recall readily in place. Section 8 of the Directive requires review of any complaint about potentially defective products following a written procedure and if necessary the effective and prompt recall of defective products from the market. It is a requirement to inform the QP and the quality control department during the review and analysis of all... 

To complicate matters in some countries, liability may also arise in tort without proof of fault. This is known as strict liability. An important example of strict liability for pharmaceutical companies is what is commonly referred to as the European Products Liability Directive , which introduced a Europe-wide scheme of strict liability for defective products, (see Chapter 52 on Pharmaceutical Product Liability ). As liability is strict, the defences that are available in the legislation are most important. The UK legislation, for example, includes a development risk defence. This essentially means that, if the state of scientific knowledge was such that the producer could not have discovered the defect, this will provide a defence to the claim. 

A strict liability regime has also been adopted by several international legal instruments, namely in the Council of Europe Convention (see 31.3.2.2), the UNIDROIT Convention (31.3.1.3) and the EC Directive for defective products (31.3.1.1). Such a regime is proposed to be adopted in the waste liability directive proposal (31.3.1.2) and in the draft HNS Convention (31.3.1.4). Also, the Commission Green Paper (31.3.3) clearly favors strict liability as a basis for liability on environmental damage. 

The EC Directive on liability for defective products [4] was adopted in 1985. According to the directive the producer is to be held liable for damage caused by a defect in his product. It is based on a strict liability regime, ie, one does not have to prove negligence or fault to be able to get compensation. What the injured party has to prove, is the existence of the danuge, the defect of a product and the causal relationship between the damage and the defect (Art. 4). 

All complaints and other information concerning potentially defective products must be reviewed carefully according to written procedures. In order to provide for all contingencies, and in accordance with Article 28 of Directive 75/319/EEC, a system should be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market... 

Biotechnology companies already anguishing over U.S. product liability concerns, as well as the lack of available coverage, are now facing strict liability laws in Europe. On July 25, the European Economic Community adopted new liability laws for defective products which member states "shall bring into force, not later than three years from the date of notification of this Directive," that is by July 25, 1988. 

Directive 85/374/EEC concerning Liability for Defective Products (Product Liability Directive) was enacted in 1987 to protect consumers from defective... 

Strict liability was established in the European Union to protect consumers (users and operators) from defective products. Directive 85/374/EEC changes the old approach of proving negligence to a new emphasis of strict liability on the manufacturer s part. Consumers can now initiate civil actions themselves, without the need to prove negligence. All producers involved in the production process are liable, insofar as the finished product, component, or raw material they supply is defective. The consumer can take simultaneous action against all parties involved in the supply chain. Moreover, the directive does not set any financial ceiling on the manufacturer s liability. 

Since the meaning of safety varies between individuals and depends on our point of view, I have purposely left the definition of safety till the end. With a thorough knowledge of safety, we can now answer the question that has been the topic of many discussions, What is a safe product The General Product Safety Directive defines a safe product as any product which, under normal or reasonably foreseeable conditions of use does not present any risk or only minimal risks compatible with the products use, considered as acceptable and consistent with a high level of protection for the safety and health of persons. Also, as stated in the Product Liability Directive, a defective product is one that does not provide the safety which a person is entitled to expect, taking all circumstances into account. ... 

TQM Principle 3, Prevention versus Inspection, directs attention toward the prevention of defective products and service [accidents and incidents], rather than the discovery of defects and deficiencies [hazards] after resources have been spent. ... 

The most contentious defence contained in the Act is usually called the development risks defence. Under this defence,the producer of a defective product will have a defence if he can show that the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description might be expected to have discovered the defect if it had existed in his products while they were under his control. Under the Directive, the Council of Ministers has the right to remove this defence following a review of its operation in the middle of 1995. 

EEC Directive on Liability for Defective Products, No. 85/374, HMSO, London (1985)... 

Prior to the Consumer Protection Act a very limited form of strict liability existed in the form of statutory liability in contract arising from the direct supply of defective products. This is defined by the Sale of Goods Act 1893 as amended by the Supply of Goods (Implied Terms) Act 1973 (now consolidated into the Sale of Goods Act 1979) and the Unfair Contract Terms Act 1977. 

EEC, Directive on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products. Directive no. 85/374/EEC, official journal no. 1210/29, Brussels (1985)... 

A recall is a request by the manufacturer of a defect product to return the product. It is the most extreme action a company can take since the losses can be big (Skees et al, 2001). In addition to the direct costs of a recall, the losses may include loss of customer confidence and the company s good name, although these are hard to quantify (Kramer et al, 2005). 

Giving judgement in favour of Biosil, it was held that Mrs Foster had to prove both the fact of the defects and their cause. The burden of proof as to causation had not been changed by EU Directive 85/374, which only replaced negligence with strict liability for defective products. On the facts Mrs Foster had not established that the implants were defechve. As to leakage, the right implant was intact when removed so the liquid left behind was probably exudates rather than silicone from the implant. 

As a result of an EEC Directive in 1985 relating to legal liability for defective products within Member States, the UK introduced the Consumer... 

The main irradiation parameters that have a direct influence on swefling are the parameters that control supersamration of point defects, all other parameters remaining unchanged, in other words mainly (for the basic parameters) the temperature, the dose, and the defect production rate. 

Liability for building works is included in the tortious liability provisions of the civil code of each country. Similarly, in the EU the Product Liability Directive 85/374/EEC of 25 July 1985 has established for EU countries legislation regarding strict product liability for damage arising from defective products. This liability is in addition to any existing rights that consumers enjoy under domestic law. 

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