Prior to entering the EU market, some goods must comply with requirements specified in the provisions adopted at the EU level. These provisions are called the harmonised rules. Check which goods are covered by these rules.
The harmonised rules are adopted by the European Union institutions and they set out the uniform standards applicable to placing the goods on the EU market, especially with regard to safety, quality and reliability of products.
There are two approaches to performing harmonisation of rules
- The former is focused on setting out detailed technical specifications at the EU level which must be met by certain groups of goods. That method is known as ‘Old Approach’. However, it has many defects. First, drafting of such a legal instrument is time-consuming – all Member States need to agree on the detailed description of requirements for certain groups of products. Second, such an approach can hinder innovativeness among economic operators who are limited by such strict rules. In Poland, rules on placing non-harmonised products on the market are set out in the Act on conformity assessment system (Journal of Laws 2019, item 155; Journal of Laws 2020, item 1339) and implementing regulations.
- The second method, implemented under the ‘New Approach’ directives, requires the EU rules to set out only essential requirements for groups of goods (harmonised rules), especially with respect to health and safety, and in such events we refer to goods. That ‘New Approach’ enables faster drafting of rules and eliminates creation of obstacles for economic operators wishing to introduce innovations in their products. Technical details are then set out in harmonised standards that in Poland are introduced by the Polish Committee for Standardisation. In that case, economic operators need to ensure themselves that their goods comply with the essential requirements. Confirmation of conformity of the goods with essential requirements is provided by CE marking – non-harmonised goods.
The harmonised rules apply to the groups of goods the usage of which may be dangerous or create some risk. Therefore, the requirements set out for such goods them must be specified in detail and meticulously complied with.
Such groups of goods include for example cosmetics, toys, construction goods, explosives, personal protective equipment, electrical equipment and machinery.
If you intend to place some goods on the single market, meaning on the market of the European Union, such goods need to be safe. Thus, verify which rules apply to these goods and make sure that they conform with the requirements set out in those rules.
Placing the goods on the market shall be understood as the first making available of the goods on the EU market. This can mean either manufacturing of the goods or importing them from a non-EU country.
Important! It does not matter in what manner you supply your goods – they must comply with the requirements set out in the harmonised rules whether they are sold physically in the shop or, for example, online. Also, the concept of making goods available is applicable to each specimen of the goods.
You can use the European Commission search engine and check if and which harmonised rules apply to the goods you intend to place on the market.
Goods need to comply with the requirements set out in the above mentioned rules as of the moment they are placed on the market and during the time they are made available on the market until they get to the user.
Accordingly, the manufacturer of goods is obliged to:
- ensure that the goods are designed and manufactured in conformity with the requirements
- prepare technical documentation of the goods
- perform or commission performance of the conformity assessment procedure; prepare declaration of conformity and add CE marking and other marking, if specified in special provisions
- ensure application of procedures aiming at preserving the conformity of batch production with the requirements, taking into account changes in the design or characteristic of the goods and in other documentation referencing declaration of conformity of these goods
- keep the technical documentation, declaration of conformity and documentation indispensable to demonstrate conformity of the goods with the requirements for 10 years as of the data the goods have been placed on the market
- add information enabling the identification of the goods on these goods or on their packaging, enclosed document or label, when specified in special provisions
- add their name, registered trademark, if applicable, and address on these goods or on the packaging, enclosed document or label, when specified in special provisions; such details should be added in Polish
- accompany the goods with instructions, information, including on safe operation and, if required, copies of declarations of conformity and labels drafted clearly, comprehensibly and legibly in Polish
- keep and analyse records of complaints relating to goods, goods not conforming with requirements and cases of goods being recalled
- examine, when justified, samples of goods made available on the market, especially in the context of the risk created by the goods
- in the case of reasonable suspicion that the goods are not conforming with the requirements, immediately take actions ensuring the conformity of the goods, their withdrawal from the market or recall
- immediately notify a competent market surveillance authority and competent market surveillance authorities of the European Union Member States and member states of the European Free Trade Association (EFTA), parties to the Agreement on the European Economic Area in which the goods have been made available, about the risk created by the goods by providing detailed information, in particular on non-conformity with the requirements and on the actions taken
- provide the market surveillance authority with information and documentation in Polish, in paper or electronic copy, to demonstrate conformity of goods with the requirements and to collaborate with such an authority to remove a risk created by the goods placed on the market.
In the case of goods imported from non-EU countries, the EU harmonisation legislation specifies the roles of an importer and an authorised representative.
Importers must ensure that:
- the manufacturer has performed the appropriate conformity assessment procedure. If an importer is not certain about the conformity of the goods with the rules, an importer must refrain from placing the goods on the market and if the goods have already been placed on the market, then corrective actions need to be undertaken. In both such instances, an importer may need to contact the manufacturer to clarify doubts relating to the conformity of the goods.
- the manufacturer has prepared technical documentation, affixed appropriate marking certifying the conformity (for example, CE marking), fulfilled its identification requirements and, where appropriate, enclosed instructions and safety information written in a language easily understood by consumers and other end-users, as required by the laws of a specific Member State.
In addition, an importer has to add on the goods (and in some specific cases on the packaging or in the enclosed documentation) three following elements: its (1) name, (2) registered trade name or its registered trademark, and (3) contact address.
For goods imported outside of the European Union and those manufactured on the EU territory, the manufacturer may appoint an authorised representative (established within the Union) to act on the manufacturer’s behalf.
The power of attorney issued by the manufacturer needs to authorise an authorised representative to perform at least the following duties:
- store the declaration of conformity and technical documentation for review by a market surveillance inspection
- collaborate with a market surveillance inspection body
- collaborate with the competent national market surveillance authorities
- undertake any actions aiming at eliminating risks caused by the goods.
In addition, the authorised representative’s duties may include (depending on the scope of the authorisation and harmonised act and procedure), inter alia:
- affixing the CE marking on the goods
- drawing up and signing EU declaration of conformity.
Prior to being placed on the European Union market, many goods must be CE-marked or marked with other specific marks typical for certain types of goods.
Such a mark provides information that a manufacturer has performed conformity assessment of its goods and determined that they meet EU safety, health and environmental protection requirements.
Important! CE marking is required for goods manufactured all over the world that are sold in the EU.
The requirement to affix the CE marking to goods/ groups of goods is set out in the rules relating to these goods.
Goods requiring the CE marking include inter alia: active medical implants, lifts, equipment intended for noise emission in the environment for use outdoors, recreational craft, equipment which may generate electromagnetic disturbance or whose operation can be affected by such disturbances, machinery, explosives for civil use, non-automatic weighing instruments, low voltage goods electrical equipment, simple pressure vessels, electric mains operated household new refrigerators, storage cabinets, freezers and their combinations, new liquid fuel or gas-fired boiler heaters with nominal heat output of not less than 4 kW and not exceeding 400 kW, ballasts for fluorescent lighting supplied by mains electricity, personal protective equipment, equipment intended for use in explosive atmospheres, pressure equipment, gas-fired equipment, medical equipment, in vitro diagnostic equipment, cableway installations designed to carry persons, radio and telecommunications terminal equipment, construction products and toys, measuring instruments (such as water meters, gas meters, weighing instrument).
Some goods are simultaneously subject to EU requirements set out in more than one directive. In such instances, before the CE marking is affixed to the goods, it needs to be ensured that they conform with all applicable requirements.
Please note! The CE marking cannot be affixed to the goods for which harmonised rules do not exist or do not require the affixing of CE marking.
Affixing the CE marking to the goods does not require any licence. However, before affixing the marking, you must:
- review the details of technical documentation
- ensure conformity with all relevant EU-wide requirements
- determine whether you can assess your product by yourself or if you have to involve a notified body
- put together a technical dossier documenting conformity
- draft and sign an EU declaration of conformity.
As the product’s manufacturer, you bear sole responsibility for declaring conformity with all of the EU requirements. The EU declaration of conformity is a mandatory document. Manufacturer or its authorised representative need to sign it to confirm that the goods comply with the EU requirements. By signing the declaration, you assume full responsibility for conformity of your goods product with the relevant EU rules.
The declaration needs to include the following information:
- name and full address of the manufacturer or the authorised representative
- serial number of the product, its model and type
- statement on the manufacturer’s liability
- means of identification of the product allowing traceability – this can include a photo/picture
- the details of the notified body which carried out the conformity assessment procedure (where applicable) if appropriate)
- the relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance
- full name and signature
- the date the declaration was issued
- supplementary information (if applicable).
For imported products, the importer must ensure that the product is accompanied by the declaration of conformity and must keep a copy of it for 10 years after the product has been placed on the market.
When the goods are CE-marked, upon the request of a competent national authority, any information and documentation relating to CE marking needs to be provided to that authority.
Standards are the voluntarily applicable guidelines incorporating technical specifications on certain products. They are prepared under the EU harmonised rules.
Application of the standards is not mandatory. However, the standards are commonly used by economic operators and significantly facilitate their operations. They allow the companies and entities using these standards to demonstrate that their goods and services have attained certain quality, safety and reliability level; economic operators may read the readily available standard relating to specific goods.
The standards are prepared by three European Standards Organisations. These are:
- CENELEC for electrotechnical standards
- ETSI for telecommunication standards, and
- CEN for standards in other sectors.
European standards may be prepared:
- under the harmonised rules commissioned by the European Commission. Around 20% of all European standards are developed following a standardisation request from the European Commission. They are harmonised standards.
- on the initiative of or in close collaboration with industry and other members or partners of the European Standards Organisations.
At the national level, the standardisation process is governed by national standardisation bodies introducing all European standards as identical national standards and, at the same time, withdrawing any national standards not conforming with the new ones.
Both European and harmonised standards are fee-based. In Poland, they can be purchased from the Polish Committee for Standardisation.
Any standard can be found on the website of the Polish Committee for Standardisation.
As there is no single list of legal instruments harmonising the requirements for certain groups of goods, presented below is a detailed description of the harmonisation directives: