Publication date: May 20, 2025
INTRODUCTION
The conformity assessment process is a key element in ensuring the safety, quality and compliance of products with applicable standards and legal regulations – both on the domestic and international markets. Its effectiveness is based on the cooperation of many entities, each of which plays a specific role and bears the assigned responsibility. The participants of this process include manufacturers, their authorized representatives, importers, as well as specialized units – certification, control and research laboratories (Article 4 of the Act of 30 August 2002 on the conformity assessment system (Journal of Laws of 2023, item 215).
Each of these entities plays an important role in ensuring that the product reaching the end user is safe, compliant with technical requirements and legally permitted for sale. Their cooperation will make it easier to eliminate threats posed by products to the life or health of users and consumers and property, as well as threats to the environment, eliminate technical barriers to trade and facilitate international trade.
MANUFACTURER AND ITS AUTHORIZED REPRESENTATIVE
The first of the listed entities participating in the conformity assessment process is the manufacturer together with its authorized representative. According to the dictionary contained in art. 5, the manufacturer means a natural or legal person or an organizational unit without legal personality who designs and manufactures a product, or for whom this product was designed or manufactured, in order to place it on the market or put it into service under its own name or mark. Authorized representative means a natural or legal person or an organizational unit without legal personality, having its registered office in the territory of a Member State of the European Union or a Member State of the European Free Trade Agreement (EFTA) – a party to the agreement on the European Economic Area, authorized by the manufacturer in writing to act on his behalf.
The manufacturer’s role is limited to, among other things, designing and manufacturing the product in accordance with the requirements specified in the relevant EU regulations. According to art. 7 sec. 1 item 1 letter A of the Act, the manufacturer or their authorized representative may subject the product to tests if it is not required to conduct tests by a laboratory independent of the supplier or recipient. The manufacturer may assess the conformity of the product in the manner specified in the regulations issued under art. 10 sec. 1 or in separate acts. If the conformity assessment has been carried out in the appropriate manner and it is required, the manufacturer draws up a declaration of conformity and affixes the CE marking. Moreover, they are also obliged to retain the documentation for the period specified in the regulations (according to art. 13a par. 1 – a period of 10 years from the date of production of the last product).
On the basis of Article 13, the principle of presumption of conformity of a product with harmonized standards or harmonized specifications was formulated. It is then presumed that the product meets certain essential requirements if it complies with the relevant provisions. In the event that the manufacturer or its authorized representative fails to demonstrate the conformity of the product with the relevant provisions of harmonized standards or harmonized specifications, they are obliged to demonstrate the conformity of the product with the essential requirements based on other evidence. If they fail to do so, the manufacturer is liable for the product placed on the market under their name.
According to art. 40a, manufacturers of products subject to conformity assessment are obliged to cooperate with other participants in the conformity assessment process with due diligence. In the event of non-compliance with the requirements not causing a serious risk, the specialized body may request the relevant manufacturer, its authorized representative, importer or distributor to remove the non-compliance or withdraw the product from the market or from use and to provide evidence of the actions taken within the time limit specified by the specialized body.
The manufacturer may authorise a representative to perform on his behalf some tasks related to conformity assessment – such a task may be the performance of tests formulated in Article 7, paragraph 1. However, it should be remembered that the representative cannot perform all the duties – especially those that belong exclusively to the manufacturer.
Other tasks that an authorised representative may perform if granted authorisation include: preparing a declaration of conformity, affixing markings, storing documentation and cooperating with supervisory authorities.
The manufacturer’s responsibility for the product cannot be transferred to its authorized representative.
IMPORTERS
The Act on the Conformity Assessment System explains that the word “importer” should be understood as a natural or legal person or an organizational unit without legal personality, having its registered office in the territory of a Member State of the European Union or a Member State of the European Free Trade Agreement (EFTA) – a party to the Agreement on the European Economic Area, which introduces products from third countries into circulation or puts them into service.
The importer may assess the conformity of the product in the manner specified in the regulations issued pursuant to Art. 10 sec. 1 or in separate acts(Art. 7a). In addition, if the declaration of conformity has been drawn up in a language other than Polish and the regulations require it to be attached to the product, the importer is obliged to translate it into Polish if the product is to be used or distributed in Poland. (Art. 8 sec. 2) If the manufacturer is based outside the EU and EFTA and has not appointed an authorised representative in the EEA, the importer must keep a copy of the product documentation and the conformity assessment for a period of 10 years from the date of manufacture of the last copy. (Article 13a paragraph 2)
According to art. 40a, the importer is also obliged to cooperate with control bodies, with due diligence, to determine whether the product meets the requirements. In the event of non-compliance being found by a specialized body, the importer may be requested to remove the non-compliance or withdraw the product from circulation/use and must provide evidence of the actions taken within a specified period. In a situation where the product does not meet the requirements and poses a serious threat, and the proceedings concern the destruction of the product, the importer becomes a party to the proceedings, bears the costs of storing and destroying the product, and is also subject to the decisions of customs and specialized bodies.
If the product poses a risk and the importer takes action on its own initiative, these actions are forwarded to the European Commission by the President of the Office of Competition and Consumer Protection (Article 44, paragraph 2).
CERTIFICATION BODIES
The Act defines a certification body as an entity independent of the entities listed in point 2 performing the certification referred to in point 8. Certification consists in the activity of a certification body demonstrating that a duly identified product or its manufacturing process are in compliance with the essential or detailed requirements; on the other hand, a certificate of conformity means a document issued by a notified certification body confirming that the product and its manufacturing process are in compliance with the essential requirements.
According to art. 7 sec. 1 point 3, the notified certification body is responsible for conducting product certification, i.e. checking whether a given product meets the essential requirements specified in the legal regulations. If the result of this assessment is positive, a certificate of conformity is issued, which constitutes formal confirmation of meeting the requirements and is the basis for further steps. According to art. 14, the certification body is obliged to protect information constituting a business secret and other legally protected data obtained during the conformity assessment.
The certification body must be independent and impartial towards manufacturers and other entities involved in the production process pursuant to Article 19, paragraph 2, point 2. This is to ensure the credibility and objectivity of the certification process. In order to be able to act as a notified certification body, it is necessary to obtain authorization. Authorization is granted at the request of such a body after meeting specific criteria, including having appropriate staff, equipment, accreditation and insurance. Authorized certification bodies may apply for notification (Article 21).
According to Article 23, the certification body is obliged to inform the relevant minister of any refusal to issue, suspension, limitation of scope or withdrawal of a certificate of conformity. Pursuant to Articles 22 and 24, the activities of certification bodies are subject to supervision and control by the relevant administration bodies, which may conduct inspections, verify compliance of activities with regulations, and in the event of irregularities, withdraw the notification.
The certification body is obliged to cooperate with other participants in the conformity assessment process and must also cooperate with specialised bodies to determine whether the product meets the relevant requirements.
CONTROL UNITS
A controlling body is a body that checks the design of a product, a product or its manufacturing process and determines their compliance with the essential or specific requirements.
According to Article 7, paragraph 1, point 2 of the Act, the inspection body is responsible for verifying the product’s compliance with the essential requirements. Its activity may be required in situations where the manufacturer’s independent assessment is not sufficient, and an independent assessment is to ensure the objectivity and reliability of the process. This body acts as a third party – independent of both the manufacturer and the recipient – which is essential for the credibility of the results of the checks carried out.
The inspection body must meet specific requirements to be able to obtain authorization, and at a later stage – notification. As it results from art. 19 sec. 2, such a body should have qualified personnel, appropriate technical equipment and demonstrate full independence and impartiality. These conditions are the basis for applying for authorization, which can then lead to notification at the EU level (art. 21). Notification authorizes the body to act on behalf of the state in the conformity assessment process on the territory of the European Union.
The activity of the inspection body does not end with checking compliance. According to Article 14, during the assessment of compliance, this body is obliged to comply with the regulations on business secrets and the protection of legally protected information. This emphasizes the responsibility that rests on it – not only for the technical aspect of the examination, but also for the ethical dimension of its work.
Importantly, the activities of control units are under ongoing supervision by the minister or head of the central office competent for the subject of conformity assessment (Article 22). The minister also has the right to control the unit (Article 24), and in the event of finding violations, may limit or withdraw authorization (Article 20). Thanks to this, the conformity assessment system maintains a high level of reliability and public trust.
LABORATORY
A laboratory within the meaning of the Act on the Conformity Assessment System is a research laboratory or a measurement laboratory.
The laboratory may be involved in the testing of the product (Article 7, paragraph 1, point 2) when the laboratory is required to be independent of both the supplier and the recipient. This is to ensure the objectivity and reliability of the results.
A laboratory that wants to obtain notified status must meet the formal requirements specified in Article 19. These include appropriate accreditation, qualified personnel, equipment, independence and impartiality. In addition, the laboratory must obtain automation granted by the minister or head of the central office. Moreover, according to Article 14, laboratories are obliged to comply with the regulations on the protection of confidential information, which guarantees the security of the manufacturer’s technological data.
After obtaining authorization, the laboratory may be notified to the European Commission and EU Member States, which allows it to operate at the EU level. The activities of laboratories are subject to continuous supervision by the relevant authorities (minister, head of the central office), which have the right to conduct inspections, withdraw or limit authorization/notification in the event of irregularities. The control of notified units is carried out by the minister and the head of the central office. The scope of the control is specified in the authorization issued by the minister or head of the central office.
Laboratories and other bodies participating in the conformity assessment system are obliged to cooperate with specialised bodies.