Introducing Products to the Market

From among the regulations that govern the Czech Trade Inspection Authority’s supervisory responsibility it is Act No. 102/2001 Coll. which is relevant to bringing a new product to market. Act No. 22/1997 Coll. is then relevant to product safety and Act No. 102/2001 Coll. is pertinent to the technical requirements for products.

ACT NO. 102/2001 COLL.

… applies to products that are intended for the consumer at large, or which could reasonably be meant for a consumer’s use, including items provided (i.e. for use) as part of a service. In Section 3 the law stipulates a number of ways of judging the safety of a product, though Paragraph 1 perhaps contains the essential definition of a safe product:

“A safe product is a product which does not present a danger to the consumer during normal use, or under reasonably foreseeable conditions of use, for the time specified by the manufacturer or for a normal period of use. Moreover, a safe product does not represent a health or safety hazard to the consumer even with only minimal use of the product. Health and safety risk to the consumer is measured primarily according to the following criteria:

a) the product’s characteristics, life expectancy, composition, packaging, instructions for assembly and use, availability, the content and clarity of the instructions, method for use including where it can be used, general labelling, warning labels, instructions for maintenance and ultimate disposal, and the clarity and array of other information provided by the manufacturer. All information must always be provided in the Czech language;

b) the product’s effect on other products, assuming it is to be used with other products;

c) the way the product is presented; and

d) the consumer risk associated with the use of the product, particularly by children and persons with limited mobility and abilities.”

The responsibility for introducing a safe product to the European market lies with a manufacturer based in the EU, an authorized representative, based in the EU, of non-European manufacturer, an importer of the product from outside the EU, as well as other entities along the supply chain whose input has a significant impact on the properties of the product. All of the above mentioned entities are grouped, in Section 5, Paragraph 1 of the law, under the term “manufacturer” and are, according to Paragraph 3, responsible for marketing only safe products. Others EU entities within the supply chain are classified as distributors and, according to Section 5, Paragraph 4, distributors may not distribute products which, based on their knowledge, expertise or supposition, do not meet the guidelines of a safe product.

In Sections 4 and 5 the Act further includes several other responsibilities of manufacturers and distributors. These include mandatory product documentation, including information about residual risks (Sect. 4, Par. 4), monitoring the safety of products already introduced onto the market, the reporting of dangerous products, and cooperation with the authorities. The law specifies “authorities” to mean the appropriate agency that is deemed competent, by special legislation, based on the nature of a particular product. If a specific agency or authority is not otherwise specified, the product falls under the jurisdiction of the CTIA.

ACT NO. 22/1997 COLL.

… applies only to specified products, i.e. those that fall under at least one of the approx. 30 regulations issued by the Government in order to implement this Act, or under an EU regulation adapted by this Act. The vast majority of them fall under the jurisdiction of the CTIA. The substantive effect of the government regulations is defined either by the type of product (such as toys, construction products, medical devices, low voltage electrical equipment, pressure equipment, machinery, personal safety equipment, gauges, radio and telecommunications equipment, aerosol sprays, safety systems and equipment for environments where explosives are used, elevators, recreational boats, etc.), or according to a specific characteristic of a product that has been significantly modified (such as noise pollution or electromagnetic compatibility).

Before introducing a specified product into the EU market, the product must be successfully assessed for conformity with the technical requirements of all applicable regulations. Compliance is designated by a declaration of conformity and the labelling of the product (with minor exceptions the product is labelled with the letters “CE”). The manufacturer, or in the case of imports from non-EU countries the importer, carries the primary responsibility for proper assessment and certification with the appropriate authority. For subsequent distribution within the European market, including between EU Member States, compliance re-assessment is not necessary. Businesses must, however, act with due diligence in order to prevent the distribution of goods that clearly do not meet the requirements of the Act: in particular they should ensure that products which they distribute have the correct certification. This implies, among other things, that not only the manufacturer or importer should know whether or not the product should undergo a mandatory conformity assessment, and thus whether or not it should have the CE designation: the distributor is expected to know this as well. The Act further generally specifies, in Section 13, a number of other responsibilities for manufacturers, importers and distributors. The nature of the responsibilities may vary according to product. It is therefore necessary to understand how each government regulation defines the specific responsibilities.

For specified products which are that are also consumer products, or where use by the consumer can reasonably be expected, the above mentioned product safety Act No. 102/2001 Coll. is also applicable.

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