Act No. 90/2016 Coll. on the Conformity Assessment of Specified Products

Sectors covered by Act No. 90/2016 Coll.

Act No. 22/1997 Coll., on technical requirements for products (as amended), remains in force alongside Act No. 90/2016 Coll. on conformity assessment, and the following sectors remain within its scope.

Structure of Act No. 90/2016 Coll. on the conformity assessment of specified products, divided into six parts:

I. PLACING PRODUCTS ON THE MARKET

II.  SPECIAL PROVISIONS ON CERTAIN MANUFACTURERS

III. MARKET SURVEILLANCE

IV. ADMINISTRATIVE OFFENSES

V. GENERAL, TRANSITIONAL, AND DELEGATION PROVISIONS

VI. ENTRY INTO

FORCE. PLACING PRODUCTS ON THE

MARKET Act No. 90/2016 Coll. on the conformity assessment of specified products provides a detailed definition of the terms: placing on the market and supplying to the market.

Placing on the market
is the first supply of a product to the European Union market; only the manufacturer or importer (product suppliers) may place a product on the market. Placing on the market occurs when the manufacturer or importer supplies the product for the first time to a distributor or end user. Any subsequent activity from distributor to distributor or from distributor to end user is considered supply to the market. Placing on the market is the most critical point from the perspective of EU harmonization regulations. By the time of placing on the market, the manufacturer has already designed the product in accordance with the essential requirements of the applicable legal act, conducted risk and conformity assessments, issued a declaration of conformity, fulfilled labeling requirements (CE marking, manufacturer’s name and address, etc.), and prepared technical documentation. The term “placing on the market” applies to each individual product manufactured individually or in series; the term “supply” does not apply to a product type.

Supply to the
market means the supply of a product for distribution, consumption, or use on the European Union market in the course of a commercial activity, whether for consideration or free of charge. When a product is placed on the market, it must comply with the Union harmonization legislation in force at the time of placing on the market. The term “placing on the market” applies to each individual product manufactured individually or in series; the term does not apply to a product type.  Placing on the market is a broader concept than placing on the market. The term “placing on the market” facilitates the tracing of a non-compliant product back to the manufacturer.

Examples not considered placing on the market:

• the supply of products for the purpose of further distribution, incorporation into a final product, further processing or improvement, or for the export of the final product outside the Union market;
• products manufactured for own use (however, some NLF regulations contain provisions for products manufactured for own use, e.g., machinery, measuring instruments, explosives for civilian use, etc.);
• products displayed or operated under controlled conditions at exhibitions, trade fairs, or demonstration events (the prototype must be safe, under the control and supervision of an expert, and public access to the product must be limited);
• a product submitted for testing or validation;
• a product under customs supervision;
• a product transferred by a manufacturer from a third country to its authorized representative to ensure compliance with NLF regulations.

OBLIGATIONS OF ECONOMIC OPERATORS
Regulated in accordance with European legislation.CONFORMITY

ASSESSMENT
PROCEDURES Regulated in accordance with European legislation. PRODUCT


TRACEABILITY

PRODUCT TRACEABILITY REQUIREMENTS:

• product marking

 

• ; identification of economic operators in the distribution chain;
• retention of technical documentation.

PRODUCT
MARKING must include the type, series/serial number, model number, or, where applicable, another identifying element (e.g., a unique code used by retailers, such as SKU—Stock Keeping Unit). If the size or nature of the product does not allow this information to be placed on the product, it may be placed on its packaging or on an accompanying document.

A product consisting of a single, non-assembled item that can be used alone or in a set with other products may have an item number indicated on the packaging.

A product consisting of multiple separate parts that are too small and are contained in a single package may have a single item number assigned to the set.

A product consisting of a single assembled item (not intended to be disassembled by the consumer) may have the item number indicated on the packaging. However, the information provided on the product or packaging must match the information stated in the EU Declaration of Conformity!

NAME AND ADDRESS OF THE MANUFACTURER A translation of the words “manufactured by” or
their inclusion before the manufacturer’s address is not required. The manufacturer must always indicate on the product, packaging, or document accompanying the product:

• their name
• ,
• their registered trade name or trademark
• , and a single address where they can be contacted

. This information must be identical to that stated in the Declaration of Conformity and in the technical documentation.

The manufacturer’s address does not have to be the place of manufacture; it does not have to be located in every Member State (MS) to which the product is supplied; it may be the address of an information point for consumers and other users in the MS; it may be the address of an authorized representative or customer service (street and number, P.O. box and number, ZIP code, and city). The manufacturer’s website address is supplementary information and is insufficient.

NAME AND ADDRESS OF IMPORTERS The phrase “imported by” or its placement
before the importer’s address is not required. The importer must indicate on the product, its packaging, or a document accompanying the product:

• their name
• ,
• their registered trade name or trademark
• , and a single address where they can be contacted

. This information must be identical to that stated in the declaration of conformity and in the technical documentation. Additional information about the importer must not obscure the information provided by the manufacturer on the product. The importer’s address need not be the location of its registered office. The importer’s website address is supplementary information and is insufficient as the importer’s address.

RETENTION OF TECHNICAL DOCUMENTATION
The technical documentation must be prepared by the manufacturer.
Technical documentation:

• provides information on the design, manufacture, and operation of the product;
• must be available when the product is placed on the market;
• must be retained for a period of 10 years from the date the product is placed on the market (= obligation of the manufacturer or its authorized representative);
• sometimes, the relevant NLF regulation for the product specifies a requirement to prepare the documentation in a language acceptable to the notified body;
• The content requirements are specified in the relevant NLF regulation for the given product (typically including a product description, its intended use, product design, all product versions, product operation, proof of product conformity with essential requirements, applicable hEN or ISO standards, and any other relevant standards).

The manufacturer must document the risk analysis and assessment in the technical documentation with regard to the intended use of the product.

RISK ANALYSIS AND ASSESSMENT
II. SPECIAL PROVISIONS FOR CERTAIN PRODUCTS

Contains specific derogations for products covered by relevant EU regulations (personal protective equipment, gas-fired appliances, cableways, medical devices, in vitro diagnostic medical devices, EU fertilizer products, unmanned systems, machinery) or special provisions for certain other products:

• lifts and safety components for lifts—
• fixed installations in terms of electromagnetic compatibility;
• recreational craft and personal watercraft;
• marine equipment;
• pressure equipment;
• radio equipment;
• interoperability of automotive radio equipment and digital television equipment

;

• non-automatic weighing
• instruments

;

• equipment and protective systems intended for use in potentially explosive atmospheres

III. MARKET

SUPERVISION IV. VIOLATIONS According to Act No. 90/2016 Coll. , the ma ximum fine for particularly serious breaches of obligations by legal entities or self-employed individuals is CZK 50 million. Fines are collected by the supervisory authority that imposed them. These fines constitute revenue for the state budget.

V. GENERAL, TRANSITIONAL, AND AUTHORIZING PROVISIONSGeneral

ProvisionsThe territorial scope of provisions concerning Member States is extended to EEA countries and Switzerland. Economic operators have the right to use the services of notified bodies from other Member States or, where applicable, bodies from third countries recognized under an international agreement with the EU. The outputs of these bodies are considered equivalent to those of Czech bodies under the law.