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Rules for Placing Products from the EU on the Czech Market
Under the EU law, products can be divided into three groups – harmonised products (the same legislation applies throughout the EU), non-harmonised products (with no common legislation, Member States set their own requirements) and partially harmonised products (only some aspects of the product are harmonized, whereas others are governed by national legislations).
Harmonized products (e.g. toys, chemical substances, etc.) should not encounter any problems when being placed on the market of another Member State because identical requirements are applied within the whole EU. Non-harmonized and partially harmonised products may be problematic because each Member State is entitled to set its own requirements. Some Member States may try to restrain free movement of goods and protect their own manufacturers through partially harmonised products.
Mutual Recognition Principle
Such a situation goes against the principle of free movement of goods because it distorts the EU internal market. The solution is so called a mutual recognition principle. This principle means that in case a product is legally placed on the market of a member state, authorities of another member state cannot prohibit its marketing. What is good enough for consumers in one country must be good enough for the other countries.
There are exceptions to this rule but the national authorities are very restricted in their opportunities to prohibit free movement of such a product. The detailed procedural rules protecting the entrepreneurs are set out in the Mutual Recognition Regulation (Regulation No. 764/2008). However, entrepreneurs should not forget that there are specific rules in every member state justified by the protection of consumers (typically labelling products in the national language).
Regulation No. 764/2008 on mutual recognition (hereinafter the Regulation) came into force on May 13, 2009. The Regulation enables member countries to establish one or more Product Contact Points. The product contact point established in the CR is called;ProCoP”. It has been operating by the EU Internal Market and Services Department of the Ministry of Industry and Trade.
The ProCoP’s main objective is to provide economic entities and competent authorities information on legal requirements on products imposed by the EU and national legislations. ProCoP supervises and coordinates other public administration bodies and ministries as to the application of mutual recognition principle. The Commission suprvises its activities. Both local and foreign entrepreneurs may contact ProCoP. Its employees are able to communicate in English.
Information to be provided
Product Contact Points shall, under the Art. 10 of the Regulation and upon request of an economic entity or a competent authority of another Member State, provide the following information:
- technical rules applicable to a specific type of a product in the territory in which Product Contact Points are established and information as to whether that type of the product is the subject to requirements for authorization under the laws of the Member State, together with information concerning the principle of mutual recognition and the application of this Regulation in the territory of the Member State;
- contact details of competent authorities within the Member State by means of which they may be contacted directly, including particulars of the authorities responsible for supervising the implementation of technical rules in the territory of the Member State;
- remedies generally available in the territory of the Member State in case of a dispute between competent authorities and an economic entity.
The information service is provided upon request (mostly by e-mail) and is free of charge. Information is given within 15 working days from the delivery of the request.
Examples of already submitted inquires can be found on the website of the Ministry of Industry and Trade.
How to contact ProCoP?
There are several way you can contact ProCoP in the Czech Republic:
- by e-mail: email@example.com.
- by telephone: +420 224 221 701
- by mail: Ministerstvo průmyslu a obchodu, ProCoP, Na Františku 32, Praha 1, 110 00, Czech Republic.
- in person: after a telephone appointment.
In case you would like to find out about requirements of national rules applicable to products you would like to export or to distribute in another EU Member State (other than the Czech Republic), do not hesitate to contact the competent Product Contact Point. You can communicate in English or in the national language of the relevant state.
Declaration of Conformity and CE Declaration of Conformity
A declaration of conformity is a written affirmation of a producer or importer (distributor) that their products meet all the valid technical requirements in the Czech Republic and that the stipulated procedure was observed when assessing the conformity.
Concerning the assessment of conformity, it is necessary to know certain basic facts on categorization of products. When placing a product on the market the most important question is whether the product falls within the regulated or non-regulated sphere.
Products not posing a higher degree of danger to the justified concern fall within the non-regulated sphere. These types of products are not subject to the assessment of conformity under the Act No. 22/1997 Coll., on technical requirements for goods. There are no specific technical requirements laid down by law concerning their placing on the market. These products must only meet general safety requirements.
In contrast, the regulated sphere covers so-called;specified products” within the meaning of Art. 12 of the Act No. 22/1997 Coll. The government specifies these products and requirements in government regulations. A conformity assessment must be carried out before placing such products on the market.
In addition, there are so-called harmonised and non-harmonised spheres.
In the harmonized sphere, technical requirements on products are laid down by secondary EU (EC) legislation. These uniform requirements are applicable in all Member States. Compliance with them is certified by the EC declaration of conformity (CE sign). The harmonized legislation serves as a tool for removing obstacles caused by different technical requirements in different Member States.
The mutual recognition principle is applied in the non-harmonized sphere (Art. 13b of the ct No. 22/1997 Coll.). That means that in principle, it is sufficient when a non-harmonized product has already been legally marketed in another Member State – in other words – that the product complied with all the legal requirements of another Member State. Regardless the fact whether the law in such a state requires the conformity assessment or not, the Czech supervisory authorities must take that fact into account. Competent authorities should take into account a foreign declaration or documents issued under rules of another Member State where the product was first launched.
Prior authorization requirement
A prior authorisation procedure is an administrative procedure which means that prior launching a product in a MemberState“s market, the competent authority of the MemberState must give a formal approval following an application of a manufacturer/distributor/importer. Such a requirement restricts free movement of goods and undoubtedly hinders trade but it can be justified when it is in a public interest protected by the EU law and when it is proportionate.
The EU Court of Justice has set a number of conditions for the prior authorization procedure to be legal: The prior authorization process must be based on objective, non-discriminatory criteria which are known in advance. It cannot consist of tests or controls performed in any other EU Member State. The prior authorization can only be required when an ex-post control is deemed not to be effective. The whole process of prior authorization must not be as costly and lengthy as to deter the entrepreneur from placing his/her product on the new market.
During the prior authorization procedure, the competent authority may reach a conclusion that the goods does not satisfy the national technical requirements and decide that the product cannot be placed on the market. In such a case the procedural rules set out in the Mutual Recognition regulation must be followed.
How to contest a decision of public authorities
In case a public authority intends to restrict the free movement of your product, firstly they are obliged to inform you and justify this intention. After that you have twenty days to give your comments. However, the relevant supervisory authority may still insist on its decision and may rule to your disadvantage. You can contest this decision several ways.
The decision, which you disagree with, was issued by an administrative authority in an administrative proceeding. General rules for administrative proceedings are contained in the Administrative Code (Act No. 500/2004 Coll.). They are applicable unless a special law states otherwise (exceptional cases).
Appealing against the decision
If the decision has not entered into force yet, you can appeal against it. This must be lodged with the authority, which issued the decision within 15 days from the notification of the decision. You are obliged to give reasons for the appeal, to indicate what you consider illegal or incorrect in the decision or in the proceedings that had preceded it. Further instructions on how to appeal against a decision should always be evident from the decision itself.
Reopening or reviewing the case
If the decision is in force already, you can use extraordinary remedies. You can propose a reopening of the case, especially if new facts or evidence had occurred. However, these facts or evidence must be able to have a significant influence on the decision. You must not have known or could not have known about them during the original proceedings. You can also suggest the decision to be reviewed by the administrative body that issued it. They will review the decision only where reasonable doubts exist that the decision is not in accordance with the law.
Action against the decision
Even if the appeal is not successful, you still have the opportunity to bring an action against the decision of the administrative authority at the competent regional court. This can be done usually within two months from the notification of the decision of the body that decided on appeal. The decision of the court cannot be appealed. In certain exceptional cases, however, it can be challenged at the Supreme Administrative Court.
Going to the European Commission
In addition to national remedies you can also lodge a complaint with the European Commission. The complaint shall be submitted in writing (letter/fax/e-mail), you can use your own language and it is free of charge. For more information visit the website of the European Commission.
You can also choose to use the services of SOLVIT centres. They informally help resolve situations where your rights guaranteed by European law have been violated. You can address SOLVIT in case you decide not to bring an action to the court (if you just appeal in the administrative proceedings, you can still turn to SOLVIT). SOLVIT has no enforcement power nevertheless, the success rate is very high (almost 90 %). It is a quick alternative and it is free of charge.