Directives General Product Safety

As evident from previous European Commission Decisions under the General Product Safety Directive [498] that were only followed by restrictions under Directive 76/769 when sufficient evidence indicated the necessity for harmonised EU technical standards. 

Finally, major FIPV chemical-related activities in Europe to utilize, or to monitor and learn from, include the development of the European Information System on Risks from chemicals released from consumer products/articles (EIS-ChemRisks). EIS-ChemRisks has been designed to be a European-wide expert and stakeholders network of networks to systematically exchange and assess information on risks from chemicals released from consumer products/articles. The overall objective is to develop tools and reference data to enable harmonized exposure assessment procedures in the European Union. These tools and reference data will support the development of a structured stakeholder dialog in the framework of the General Product Safety Directive (GPSD, 2001/ 95/EC) and progressively in the framework of the European Commission s REACH program as it is established and implemented. 

CE Marking Directive 93/68/EEC states that the choice of conformity assessment procedures must not lead to a lowering of safety standards of electrical equip-ment/products, which have already been established throughout the Community. Alternatives to European standards are possible in the case where no European harmonized standard exists. Conformity to International standards (i.e., lEC) or European national standards (i.e., DIN, BS, NF) is sometimes an acceptable alternative, but in this case the manufacturer must be able to demonstrate conformity with the ERs of the directives and at the same time not fall below the minimum acceptable criteria. The General Product Safety Directive 92/59/EEC allows the use of EU national standards when no European harmonized standards exist. This alternative may be needed as a transitional measure until a European standard is published (see General Product Safety in Chapter 2). This approach is not recommended when European harmonized standards exist, especially if a product becomes suspect, since... 

Basic directives (type A). The basic directives apply to all manufacturers of products and address trade, enforcement, liability, and other issues. It is important to understand the implication of these directives, especially concerning enforcement against product manufacturers. Examples of the basic directives are CE Marking, Conformity Assessment, General Product Safety, and Product Liability. Products, components, and materials not covered by Type B or C directives must still be safe according to the General Product Safety Directive (e.g., comply with standards). 

Furthermore, the General Product Safety Directive states ... 

Electrical safety is not limited only to products covered by the Low-Voltage Directive (LVD). According to the Machinery Directive, machine designers must also be aware of electrical safety since machines pose electrical hazards and they utilize numerous electrical components and subassemblies. The Low-Voltage Directive, General Product Safety Directive, and Machinery Directive mandate a product s conformity with the relevant electrical, mechanical, component, and other safety standards. To ensure that machinery electrical hazards are addressed by machine manufacturers, EN 60204-1/IEC 204-1 (Electrical Equipment of Machines) was published in both the Low-Voltage and Machinery directives, and, therefore, electrical requirements must also be applied to machinery. EN 60204-1 is a generic safety standard (type B) used in conjunction with the relevant machine safety standards (type C). 

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. ... 

There is also an EU directive on product safety (2001/ 95/EC), also called the General Product Safety Directive (GPSD). It covers consumer products not covered by other directives for specific sector products, such as toys, chemical, cosmetics, and machinery. 

Generally, new products are subject to the CE marking directives, however, another non-CE marking directive, e.g., the Marine Directive (the wheel mark ), an Automotive Directive (the e-mark ), or the General Product Safety Directive (EC 1997) (no marking) may apply. A manufacturer must determine which marking scheme applies and follow the applicable conformity assessment rules. 

Under the General Product Safety Directive if a Member State adopts emergency measures to prevent, restrict or impose specific conditions on the marketing or use, within its territory, of a product or product batch because of a serious and immediate risk to the health and safety of consumers, it must immediately inform the Commission, unless the effects of the risk do not or cannot extend beyond the territory of that Member State. The Commission will immediately inform the other Member States who will inform the Commission of any measures adopted to counter the risk. The Commission can intervene directly if it becomes aware through notification or information from the Member States of the existence of a serious and immediate risk from a product, and if ... 

For the purpose of improving safety and efficacy, there are three Specific Product Safety Directives for active implantable medical devices, for other medical devices, and for in-vitro diagnostic medical devices. There is also a General Product Safety Directive, intended for "all medical devices that are supplied in the course of a commercial activity for use by consumers" to which none of the three Specific Product Safety Directives can be applied. 

Dedsion 2010/15/EU, 2009. Commission Decision of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System RAPEX established under Article 12 and of the notification procedure established under Article 11 of Directive 20011951EC (the General Product Safety Directive) (notified xmder document C(2009) 9843). 

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