Product conformity assessment system in Poland

(authors:  Barbara Miareczko M.Sc., Małgorzata Jędrzejewska, M.Sc., CIOP-PIB)

-              Legal basis
-          Introducing the provisions of technical harmonisation directives into Polish law
-          System of controlling products placed on the market
-          Criminal liability

Legal basis for the product conformity assessment system in Poland

The essential law defining the principles of the product conformity assessment system in Poland is the Act of 30.08.2002 on the conformity assessment system (Official Journal 2002, no. 66 item 1360 with amendments).

The Act defines 24 basic notions used in the conformity assessment system (art. 5). By virtue of delegation in art. 9, competent ministers for the subjects of conformity assessment, introduce the New Approach Directives by regulations. By virtue of delegation in art 10, they can introduce the rules defined in other EC acts by regulations.

Apart from the principles of the conformity assessment system (articles 6 - 14) the Act also regulates:

• Principles and procedures for accreditation, authorisation and notification (articles 15 - 24),
• Duties of the Polish Centre for Accreditation (articles 25 - 36),
• Operation of the product conformity assessment system (articles 38 - 44)
• Criminal liability for placing products on the market that are inconsistent with the essential requirements, i.e., the ones set out in the New Approach Directives, or inappropriately marked (articles 45 -47c).

The provisions of the Act refer to most products. Under the Act, 38 EU directives were introduced into Polish law.

For assessing the conformity of marine equipment, the provisions of the Act are applied subject to the amendments of the Act of 20.04.2004 on marine equipment (Official Journal 2004, no. 93, item 899 with amendments).

Certain provisions of the Act on conformity assessment system, mainly related to product control, are not applicable to construction products (see art. 1 sec. 3). Also, the main requirement for construction products should be understood as essential requirements defined in the Construction Law, of 07.07.1994 (Official Journal 2010, no. 243, item 1623 with amendments).

Provisions of the Act of 30.08.2002 on the conformity assessment system, are not applicable to medical products and products for national defence and safety.

The principles of conformity assessment system for the above groups of products are set out respectively in:

• Medical products Act of 20.05.2010 (Official Journal 2010 no. 107, item 679 with amendments),
• Act of 18.10.2006 on the conformity assessment system for products for national defence and safety, (Official Journal 2006, no. 235, item 1700 with amendments).

The Labour Code also provides for conformity assessment:

Art. 217. It is unacceptable to equip workstations with machinery or technical appliances that do not meet the requirements of conformity assessment, defined in separate regulations.

Art. 237⁶. The employer is obliged to provide the employees with personal protective equipment (free of charge) protecting them from dangerous and harmful factors in the working environment, and instruct them on the methods of using them..

The employer is obliged to supply the employees with personal protective equipment which meet the requirements of conformity assessment defined in separate regulations.

The resolution of European Council of 07.05.1985, introduced several directives for technical harmonisation (i.e. so called New Approach Directives), concerning the obligatory conformity assessment of various types of products.  

EU member states are obliged to introduce the technical harmonisation directives in their national law in a form preferable for them (acts, regulations, decrees etc.).

Apart from essential requirements concerning safety and health protection, which should be observed while designing and manufacturing products, those directives established procedures of assessing conformity of products with those requirements. The provisions of the New Approach Directives were introduced into Polish law by way of delegation of the Act of 30.08.2002 on the conformity assessment system.

The regulations issued by competent ministers in terms of the subject of assessment set out essential requirements for the products subjected to the assessment as well as procedures of conformity assessment. Those procedures take into account the types of products and the degree of hazards they pose, and other requirements contained in the New Approach Directives. The information on current legislations is available on the website of Ministry of Economy 

           
The Act on conformity assessment explicitly sets the scope of obligatory conformity assessment, required before placing a product on the market or putting into service. The products placed on the market or put into service, are subject to conformity assessment in terms of:

• Essential or detailed requirements set out in regulations issued by competent ministers in terms of the subject of conformity assessment,
• Essential and detailed requirements set out in separate acts.

The mentioned assessment is obligatory before placing a product on the market or putting into service. The manufacturer of their authorised representative, who performed the conformity assessment on the product or its manufacturing process, and confirmed their conformity, issues a declaration of conformity with essential requirements and places the CE mark, according to the requirements of the New Approach Directives.

It is assumed that a products is in conformity with essential requirements, if it is in conformity with the harmonised standards. Should the manufacturer or their authorised representative fail to prove the product is in conformity with the harmonised standards, they are obliged to prove the conformity of the product with essential requirements with other evidence.

The requirements related to supervision over products subject to conformity assessment were introduced by the Act of 30.08.2002 on the conformity assessment system. The Polish system of market supervision consists of the President of the Office of Competition and Consumer Protection and specialised bodies listed in the Act. The President of the Office of Competition and Consumer Protection monitors the operation of the whole system, while the specialised bodies perform controls of products and carry out proceedings with products that are not in conformity with essential requirements.

The inspection of products in terms of essential requirements is performed by: voivodship inspectors of Commercial Inspection, labour inspectors, President of the Office of Electronic Communications, offices of Inspectorate of Environmental Protection, President of the Office of Rail Transportation, offices of building control, President of the State Mining Authority, directors of sea offices, and Chief Inspector of Road Transportation. The subject of control may be a product, the correctness of CE marking, and technical documentation of the product.

The abovementioned Act specifies the principles of criminal liability in the cases of placing products on the market that are not in conformity with essential requirements, and breaching the rules of marking products with the CE mark. A fine is imposed on entities which:

• place on the market or put into service products not in conformity with essential requirements,
• place the CE mark on a product that is not in conformity with essential or detailed requirements, or whose manufacturer or their authorised representative did not issue the declaration of conformity,
• place on the product a mark similar to the CE mark, which may mislead users, consumer, or distributors of the product,
• place on the market or put into service products subject to CE marking, but not marked,
• place the CE mark on a product that is not subject to this marking or put this product into service.

Member states are obliged, by a safety clause, to take all necessary actions in order to prohibit, limit placing on the market, or remove from the market products with the CE mark if those products when used according to their purpose, may pose a threat to people’s safety or health or other public interest.

Member states must inform the European Commission of such actions. If the Commission deems those national actions justified, it informs all member states about who should take appropriate actions to realize the common obligation of implementing the community law.