Information about market surveillance - Yleistä

 

General information on topic

Market surveillance covers all products that are subject to requirements laid down in the European Union’s harmonisation legislation.

Requirements for machinery are set out in the European Machinery Directive and requirements for personal protective equipment in the Personal Protective Equipment Directive. The Directives have been transposed into Finland’s national law by means of the Government Decree on the Safety of Machinery and the Government Decision on Personal Protective Equipment.

Occupational safety and health authorities’ market surveillance covers all those who sell or supply technical devices such as machinery or personal protective equipment for professional use. These kinds of operators include manufacturers, importers, retailers and individuals such as employers who build machinery for their own use.

The Finnish market surveillance authorities include the Regional State Administrative Agencies’ Divisions of Occupational Safety and Health and the Ministry of Social Affairs and Health’s Department for Work and Gender Equality. The primary responsibility for ensuring the regulatory compliance of products lies with the Regional State Administrative Agencies’ Divisions of Occupational Safety and Health. Cases that require action beyond their authority are referred to the Ministry of Social Affairs and Health. The Ministry of Social Affairs and Health’s Department for Work and Gender Equality can order technical devices to be recalled or restrict their sale.

Market surveillance carried out by occupational safety and health inspectors

Occupational safety and health inspectors visit facilities where products are sold, showcased and used to ensure that any machinery, personal protective equipment and other technical devices that are intended for professionals are safe to use as intended and that they carry all the necessary markings and are supplied with the required documents. If any issues are found, the inspectors can instruct the manufacturer, importer or retailer to rectify the non-conformances. If the inspectors’ instructions are not enough to make the products conform with the relevant requirements, they report their findings to their Regional State

Administrative Agency’s Division of Occupational Safety and Health, which then refers the case to the Ministry of Social Affairs and Health’s Department for Work and Gender Equality.

Occupational safety and health inspectors also make sure that all equipment designed for professional use complies with the regulations concerning noise emissions from equipment operated outdoors. Any non-conformances found are reported to the regional Centre for Economic Development, Transport and the Environment, which refers the case to the Ministry of the Environment.

Temporary prohibitions issued by occupational safety and health inspectors

Occupational safety and health inspectors can prohibit Finnish manufacturers and importers (who import products into the territory of the European Union) from placing machinery or personal protective equipment on the market in Finland and from supplying products to professionals in Finland. This can be done if the equipment does not satisfy the relevant requirements or if it could, even when used as intended, pose an immediate risk to the safety of the operator or other persons.

These kinds of prohibitions are designed for situations in which inspectors need to urgently prevent the distribution of non-compliant or dangerous equipment to customers. Inspectors can also impose similar prohibitions on Finnish distributors, i.e. individuals or companies that supply machinery or personal protective equipment manufactured or imported by others or sell such products to professionals themselves.

The prohibitions imposed by occupational safety and health inspectors are temporary. All temporary prohibition notices are reported to the Regional State Administrative Agency’s Division of Occupational Safety and Health, which transfers such cases to the Ministry of Social Affairs and Health’s Department for Work and Gender Equality.

Occupational safety and health inspectors can also prohibit the sale or supply of chemicals or equipment containing chemicals on a temporary basis. This can be done if an inspector suspects that a chemical or a device or product containing chemicals has been placed on the market contrary to the laws governing chemicals. These kinds of cases are ultimately referred to the Finnish Safety and Chemicals Agency.

Authority of the Regional State Administrative Agencies’ Divisions of Occupational Safety and Health

The primary responsibility for ensuring the regulatory compliance of products lies with the Regional State Administrative Agencies’ Divisions of Occupational Safety and Health. If non-compliances identified in machinery or personal protective equipment cannot be rectified within their authority, the case is referred to the Ministry of Social Affairs and Health’s Department for Work and Gender Equality.

Cases in which an inspector has temporarily prohibited the distribution of machinery or personal protective equipment are also referred to the Ministry of Social Affairs and Health’s Department for Work and Gender Equality. Cases that have warranted a temporary prohibition under the Finnish Chemicals Act are referred to the Finnish Safety and Chemicals Agency.

Decisions of the Ministry of Social Affairs and Health’s Department for Work and Gender Equality

The Ministry of Social Affairs and Health’s Department for Work and Gender Equality can prohibit the sale or use of non-compliant or dangerous technical devices, such as machinery and personal protective equipment. Alternatively, conditions or restrictions can be placed on the distribution of products. These kinds of restrictions can only be imposed on Finnish manufacturers, importers and retailers.

The Department for Work and Gender Equality can also order a Finnish manufacturer, importer or retailer of technical devices to

  • recall equipment
  • take steps to prohibit the use of equipment
  • dispose of any equipment that is in their possession or that has been returned to them, if the equipment poses a serious threat to health and safety, or
  • publish information about the authorities’ orders, the risks posed by equipment, and the rights of operators who have purchased such faulty equipment.

Market surveillance programmes

Market surveillance carried out by the occupational safety and health authorities is usually based on observations made in connection with inspections as well as issues reported by customers. In addition, Regional State Administrative Agencies’ Divisions of Occupational Safety and Health implement a market surveillance programme compiled by the Ministry of Social Affairs and Health’s Department for Work and Gender Equality for machinery and personal protective equipment.

The European Market Surveillance Regulation obligates Member States to draw up a market surveillance programme. Finland’s national market surveillance programme was drawn up by the Ministry of Economic Affairs and Employment in cooperation with other government departments. The market surveillance programme specific to machinery and personal protective equipment was drawn up by the Ministry of Social Affairs and Health.

Market surveillance and economic operators

Economic operators in this context include manufacturers, agents, importers and distributors of machinery and personal protective equipment. These include the following kinds of individuals or companies:

  • Manufacturers, who design and build or commission others to design or build machinery or personal protective equipment, which is then marketed to customers under the manufacturer’s own name or trademark
  • Agents, who represent manufacturers within the European Union and attend to certain responsibilities of theirs on the basis of the manufacturer’s written authorisation
  • Importers, who import machinery or personal protective equipment into the European Union from third countries and make the equipment available to others within the Union, and
  • Distributors, who make machinery or personal protective equipment that has been supplied to them by other economic operators available on the market within the European Union.

Obligations of economic operators

The obligations of economic operators are laid down in the Finnish Act on the Conformity of Certain Technical Devices to Relevant Requirements. Further provisions on economic operators’ obligations are set out in the Government Decree on the Safety of Machinery and the Government Decision on Personal Protective Equipment. The law sets out the following general obligations for economic operators:

Manufacturers and their agents (as specified in their authorisation) must

  • design and build machinery so that it is fit for its intended use and does not pose a risk to safety or health when used as intended
  • demonstrate, in a reliable manner, that all technical devices produced by them conform with the applicable laws
  • have available all the technical documentation needed to demonstrate regulatory compliance to the authorities
  • draw up any necessary user manuals and maintenance instructions to be supplied with the equipment, and
  • affix labels that demonstrate the regulatory compliance of their equipment to the equipment, along with labels that enable the equipment to be identified if necessary.

Importers must

  • ensure that any technical devices that they import into the European Union and make available or commission within the Union conform with the applicable laws and
  • assume responsibility for the manufacturer’s obligations if they market equipment in their own name and the manufacturer has not taken care of their obligations.

Distributors must, before making technical devices available on the market, ensure that

  • there are no obvious safety-related issues with the equipment
  • the equipment is supplied with any necessary instructions in Finnish and Swedish, and
  • the equipment carries a label that demonstrates its regulatory compliance and can, if necessary, be supplied with documents that demonstrate its regulatory compliance, including
    • CE marking in the case of personal protective equipment and machinery
    • an EC declaration of conformity in Finnish and Swedish for machinery
    • an EC declaration of conformity for personal protective equipment, and
    • labels warning about the dangers of the equipment in Finnish or Swedish or depicted by unambiguous symbols or pictograms.

It is also important to note that employers who build equipment within the meaning of the Finnish Government Decree on the Safety of Machinery (400/2008) for their own use are subject to the same obligations as manufacturers. Cases in which the intended use of technical equipment changes are treated as if a new device had been manufactured, and the party performing the modifications is subject to the obligations of manufacturers.

Potential sanctions to be imposed on economic operators for non-compliances

The Finnish Act on CE Marking Violations provides for sanctions for individuals who affix CE marking to equipment even though

  • they are not the manufacturer or authorised by the manufacturer
  • the equipment in question does not, pursuant to the EU’s harmonisation legislation, require CE marking, or
  • the equipment in question does not conform with the applicable laws.

A penalty can also be imposed on anyone who affixes labels that can mislead users in respect of the objective of CE marking or the graphics used.

The Finnish Act on the Conformity of Certain Technical Devices to Relevant Requirements lays down sanctions for manufacturers and distributors of technical equipment intended for professional use who violate the provisions of the Act. Individuals can also be convicted of health offences.

Information about market surveillance - Työnantajalle

 

Instructions for employer

Employers who build machinery for their own use or any technical equipment that is not governed by the EU’s harmonisation legislation are treated as manufacturers. Manufacturers are subject to certain regulations concerning the design and manufacture of technical equipment.

Employers must ensure that all machinery, personal protective equipment, tools and other technical devices that they give for their employees to use are fit for their intended purpose and safe to use.

Employers must also ensure that any new machinery and personal protective equipment that they purchase for their employees to use carry CE marking and are supplied with the manufacturer’s instructions at least in Finnish and Swedish. Machinery must also be supplied with an EC declaration of conformity.

Employers who are planning to purchase second-hand machinery or other technical equipment must ensure that the equipment is supplied with any necessary operating instructions. The operating instructions associated with work equipment must be easily understandable and kept available to employees in the workplace.