Risk Analysis & Certificates
If your product meets your expectations, the marketability of your product must also be ensured. To do this, we examine the risks of your product in a risk analysis. If the risk analysis reveals that necessary tests are missing, we take care of the tests that are still required.
Product Safety Act
Obligations of the importer according to product safety law
Validity of the Product Safety Act
The Product Safety Act actually applies to all products, the only exceptions being antiques, used items, military items, food/feed, living plants and animals, medical devices and plant protection products.
A product may only be made available on the market if it does not endanger the safety and health of people when used as intended and foreseeably. Particular attention must also be paid to groups of people who are at risk (children, pregnant women, etc.). Be warned of any possible risk, e.g. B. in an attachment/insert.
For this reason, a risk assessment is required for every product.
All warnings, safety instructions and operating instructions must be provided in German.
To assess whether a product may be made available on the market, the relevant standards should be consulted. If compliance with the standards during production is proven, the presumption applies that the product meets the safety requirements and can be made available on the market.
The importer must be clearly recognizable on the product, in particular by the name and contact address on the product (e.g. by a sticker, engraving, imprint), and the product designation and model designation must be applied to the product (identification features).
Clear and easy-to-understand information on risks associated with the product must be attached to the product, the packaging or the enclosure (e.g. manual) in German.
Regular spot checks/sample tests
The manufacturer (importer) must carry out regular random checks on his product. The sampling required depends on the level of risk associated with the product and the means of avoiding the risk. A record should be made of the sample test in order to be able to prove the sample test. If tests reveal additional risks that pose risks to the safety and health of people, the importer must immediately inform the market surveillance authority about how to avoid the risk and about the recall process. If the importer informs the authorities himself about the risks of his product, which he has determined in a random test, neither criminal proceedings nor administrative offense proceedings may be initiated against him.
CE mandatory articles
It is forbidden to make a product available on the market if the product, the packaging or the accompanying documents are provided with the CE marking without being a CE-mandatory article. If it is an article subject to CE, the article may not be made available on the market without being provided with the CE marking. The CE marking must be clearly visible, legible and permanently attached to the product or its type plate. If a notified body has carried out the production control, the code number of the notified body appears next to the CE.
Market surveillance: Obligation to comply with standards
– If standards are not met, the market surveillance authority can prohibit sales in Germany
– The market surveillance authority can order measures that result in the product only being made available on the market if it meets the requirements.
– The market surveillance authority can order the inspection by a notified body or equivalent body
– The market surveillance authority can prohibit the provision on the market for the period that is absolutely necessary for the examination.
– The authority can order the withdrawal or recall of a product that is already on the market.
– The market surveillance authority and its authorized persons are authorized to enter the business premises and business premises during business hours, in or on which products are manufactured, used, stored or exhibited for the purpose of making them available on the market. Samples may also be taken, documents and information may be requested in order to check the conformity of the products. Samples, documents and information must be made available to the authority free of charge.
Upon request, the manufacturer must submit the technical documentation to the market surveillance authorities after the product has been placed on the market, which must include at least the following:
- A general description of the product
- Drawings, results of examinations/tests etc.
- Documentation of the risk assessment
- applied standards
- if required by the risk assessment: operating instructions, instructions for use or installation instructions. .
- If applicable, declaration of incorporation or EU/EG declaration of conformity for supplier parts
- EC Declaration of Conformity
Obligations of economic operators
The manufacturer must ensure that the product he provides corresponds to the type tested. Only compliant products that comply with the relevant standards may be made available on the market.
The manufacturer is liable for the product if he is based in the EU, otherwise the representative/authorised representative who is based in the EU and has been authorized by the manufacturer to do so. If there is no other representative in the EU, the fulfillment service provider where the goods are stored and from which the goods are shipped in the EU is otherwise liable.
The economic operators have to ensure that an EU declaration of conformity, a declaration of performance and technical documentation have been drawn up for the product. The declaration of conformity or declaration of performance must be kept ready for the supervisory authorities. This must be made available to the authorities upon request.
Upon reasoned request from a market surveillance authority: Submission to the authority of all information and documents necessary to demonstrate the conformity of the product in a language that can be easily understood by that authority.
If there are reasons that a certain product poses a risk: inform the market surveillance authority.
Labeling of product on packaging: The product, packaging or accompanying document must be marked with the name, trade name or trademark and contact details including postal address of the manufacturer or his representative.
the manufacturer of a product or his authorized representative must introduce and apply regular and effective quality control with defined test procedures. These must be carried out and recorded at regular intervals (quality assurance system).
Quality is the most important requirement in the manufacture of products. Conformity is intended to ensure consistent quality. Conformity tests are required by law as part of the conformity procedure.
The manufacturer of a product is obliged to develop and carry out a quality assurance procedure. Conformity of production procedures are designed to ensure that each product, system, component and separate technical unit manufactured conforms to the sample tested as “conforming”. This is the only way to guarantee quality.
Each manufacturer of a product must introduce and apply defined test methods for effective control and is responsible for the compliance of his products with the required quality. At the request of the supervisory authority, he must make the test results available.
These test procedures must be carried out and recorded at regular intervals.
Where a product is offered for sale online or through any other form of distance selling, the product is deemed to have been made available on the market if the offer is made to the end-user in the EU. A sales offer is deemed to be addressed to end users in the EU if the relevant economic operator directs its activities in any way towards a member state of the EU.
control of the customs authorities
The customs authorities suspend the release of a product for free circulation if the inspection (import) establishes that:
- a) The product is not accompanied by the documents required by Union law or there are reasonable doubts as to the authenticity, correctness or completeness of the documents.
- b)The product is not properly marked or labeled
- c) The product bears a CE marking or other marking that has been affixed in an untruthful or misleading manner
- d)The name, trade name or registered trademark and contact details including postal address of the responsible economic operator are not indicated.
- e) There are other reasons to believe that the product poses a risk to health, safety, the environment or any other public interest.
Criminal provisions according to the Product Safety Act
Violations can be punished with up to one year imprisonment or a fine
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