Market Surveillance

About market surveillance

Market surveillance came into the national legislation throughout the implementation of the New Approach directives within the harmonization of the Hungarian legislation. The introduction of the legislation of the European Union (EU)  , the requirements of the placing on the market of certain products have been changed in Hungary before joining to the EU. The traditional legislation subjected the placing on the market of certain industrial products to the authority licensing or to the compulsory preliminary certification. The new system is based on the liability of the manufacturer. According to New Approach directives (which are transposed to Hungarian law) the products are subjected to the conformity assessment procedures prior to the placing on the market. To carry out the conformity assessment procedure is the task of the manufacturer. In case of conformity of the product with the relevant basic requirements, the manufacturer puts the CE marking on the product. Products bearing the CE marking may be released into free circulation – not only in the territory of the European Union, but in the European Economic Area (EEA, i.e. the 27 member states of the EU  and Iceland, Norway , Liechtenstein), furthermore in Turkey, too. The pre-licensing system has been replaced by the post market surveillance.

1. The principles of market surveillance

Market surveillance is a tool for enforcing the requirements of the New Approach directives in the European Union.

Its aim is to ensure that the requirements of concerning laws are applied at Community level, contributing by this to the free movement of complying products, to the same level of protection of the citizens in the single market, regardless the origin of the product. To ensure this protection, the member states operate market surveillance authorities which have the necessary powers and knowledge to carry out their tasks. They shall carry out their duties independently, impartially and without bias.

2. Market surveillance activity

The national market surveillance authorities monitor the conformity of products − with the relevant new approach directives and/or the implementing legislation − placed onto their market or put into service in their territory.

In case of non-compliance they take measures needed to bring the product in question compliant, or if it is not possible, they may order to prohibit or restrict the products  being made available on the market, to withdraw it from the market or to recall it.

For purposes of inspections they regularly visit

• manufacturers, importers, distributors, stocks, commercial and industrial places;
• operators, users (workplaces and other premises, where products are installed);
• trade fairs, exhibitions and demonstrations.

The subject of the inspection is the product itself, the CE marking, the accompanying documents, the EC declaration of conformity, and if it is needed the construction technical file partly or completely.

When it is necessary, they carry out physical and laboratory checks or order the testing of the product in question by a third party organization.

3. Measures taken in case of non-compliance, sanctions

1)         If the product presents a minor safety or other fault, which can be eliminated easily before placing on the market:

• warning;

order to bring the product  into compliance.

2)         In case of a serious fault, must not be placed further product on the market, until the product are brought into compliance. The (new) repaired products must be marked with new identification mark. The sanctions may be:

• sales ban, prohibition of placing on the market;
• recall from the market;
• withdrawal from the end-users.

4. Accompanying measures

Besides the measures above depending on the gravity of the defect, the authority has to take into account the principle of proportionality, and further measures may be required.

The market surveillance authority has the following powers:

• alerts the users within their territories within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage;
• to render the product inoperable;
• to fine
• in case of suspicion of crime or misdemeanour the authority reports to the police.

Entitlements of authorities are different a certain extent in member states of European Union and in the national law. There is an effort community and national level to standard and to level the activities of market surveillance of member states.

The new approach directives don’t determine the sanctions to be applied. Member states can form them according to sanctions applied in case of violation of laws with similar nature or importance.  Hoverer, the sanctions must be effective, proportionate and deterrent.

5. Notification obligation

When the member states apply the prohibition or withdrawal in case serious fault, they shell inform the European Commission and all other member states on the measures taken.  

There is additionally an information system at EU level, the Rapid Alert System (RAPEX) made by EU Commission. The system contains information about dangerous or non-compliance products graded by authority of member states for other authorities, manufacturers, users or consumers.

6. Historical overview

Past:

Market surveillance of certain products intended for commercial and industrial purposes had been carried out by the Hungarian Technical Safety Office (HTSO) and its regional inspectorates, until 31^st of December 2005, based on the authorization of the governmental decree 110/2003. (VII. 24.) Korm. rendelet and the ministerial decree 58/2003. (IX. 23.) GKM rendelet.

After 1st of January 2006 when merging the HTSO to the Hungarian Trade Licensing Office (HTLO) the above market surveillance tasks were managed by HTLO and its regional authorities, based on the governmental decree 297/2005. (XII. 23.) Korm. rendelet.

Market surveillance of certain measuring instruments (MID, NAWID) had been carried out by the National Measuring Office (NMO) and its regional inspectorates until 31th of December 2006, based on the measuring law 1991. évi XLV. törvény.

After 1^st of January 2007 when merging the NMO to the Hungarian Trade Licensing Office (HTLO), too, the above market surveillance tasks were managed by HTLO and its regional authorities, based on the governmental decrees 260/2006. (XII. 20.) Korm. rendelet and 26/2008. (II. 14.) Korm. rendelet, furthermore after 1^st of January 2010 the regulation No. 765/2008 of the European Parliament and Council.

After 1^st of January 2011 the market surveillance of the products listed below was carried out by the Trade and Market Surveillance Authority, Budapest of HTLO based on the governmental decrees 320/2010. (XII. 27.) Korm. rendelet, 321/2010. (XII. 27.) Korm. rendelet and regulation No. 765/2008 of the European Parliament and Council, furthermore  after 1^st of September 2012 law 2012. évi LXXXVIII. törvény about market surveillance of products.

Present:

From 2^nd of February 2013 Market Surveillance and Technical Supervisory Authority does the market surveillance in HTLO according to governmental decree 320/2010. (XII. 27.) Korm. rendelet henceforward. The market surveillance activities of HTLO are set out by governmental decree 321/2010. (XII. 27.) Korm. rendelet, law 2012. évi LXXXVIII. törvény about market surveillance of products, ministerial decree 6/2013. (I. 18.) Korm. rendelet on detailed rules of market surveillance activities and regulation No. 765/2008 of the European Parliament and Council.

7. Partner authorities

Beside HTLO other Hungarian authorities had market surveillance tasks:

• Office of National Chief Medical Officer (OTH) of State Public Health and Medical Officer Service and public health's services of the capital city and county government offices and district public heath’s institutes of district (capital district) office of capital city and county government (capital district) offices,
• Office of Health Authorisation and Administrative Procedures (EEKH),
• Pharmaceuticals and Healthcare Quality and Organization Development Institute (GYEMSZI),
• Hungarian Office for Mining and Geology (MBFH) and the mine captaincies,
• Hungarian Authority for Consumer Protection (NFH) and consumer protection inspectorates of the capital city and county government offices,
• National Transport Authority (NKH) and  transport inspectorates of the capital city and county government offices,
• Labour Safety and Labour Directorate of National Labour Office (NMH) and labour safety’s and labour’s  specialized administrative bodies of the capital city and county government offices,
• National Media and Infocommunications Authority (NMHH),
• Directorate General for Disaster Recovery BM (BM OKF),
• Administrative bodies of Police.

A National Tax and Customs Administration and territorial bodies of it take part in control of imported products with association competent market surveillance authorities in given cases.