What is a harmonized standard?
In order to comply with legal requirements for products in the EU, technical standards are needed in practice. Which standard is ultimately applied is left to the product owner. However, he must also be able to justify why he has used precisely this standard to implement the product law. The situation is different with harmonized standards. If these are applied, the legislator assumes that the requirements of the corresponding product law are implemented.
How old may test reports be?
Test reports are often used as evidence of compliance with product legislation, e.g. REACh or EMC. How old these may be depends on how complete they are and whether the procedures used to prove a particular product property are still current. Whereas new test requirements are added approximately every 6 months for REACh legislation, relevant test standards for EMC legislation can change even after 5 years. So there is no general "expiry date" for test reports. But as a rule of thumb, test reports should not be older than 2 years.
How do I manage to provide proof of chemical safety for my product?
The trade-e-bility GmbH has developed a risk-based approach in order to be able to break down the legal requirements to the essential parameters in a targeted manner for your product. Here, the multitude of parameters to be verified is reduced to the materials used in your product - this helps you to implement the legal requirements in a practice- and risk-oriented manner and can consequently also reduce your costs for chemical testing.
What is an artwork check and what does it involve?
"Artwork" includes all descriptions and markings of the product on the product itself, the packaging, the operating instructions and possibly at the POS - this may also apply to the presentation in an online store. With the "Artwork Check", we evaluate whether the information presented there is complete and complies with the law.
Which technical documents are relevant for a marketability assessment?
The marketability test assesses the extent to which the technical documents are sufficient to prove the implementation of the product law requirements in the market. In this respect, the technical documentation must both sufficiently describe the product itself and contain all legally required declarations and proof of suitability.
These are ideally:
- Technical data sheet
- Picture of the product
- Declarations of conformity (for CE and food contact products)
- Test reports
- Layout of product labeling, operating instructions and packaging
- Presentation of the product documentation in the online store
Do I need a branch in the EU to sell products to the EU?
For all CE-marked products, a branch office in the EU - or alternatively a contractually bound authorized representative based in the EU - is mandatory.
What will change as a result of Brexit if I sell products from the EU to the United Kingdom (UK)?
Since 01.01.2021 the United Kingdom, consisting of England, Wales and Scotland, is a foreign country of the EU. I.e. the conditions of the United Kingdom apply. The CE marking has been replaced by the UKCA marking, which can be used from 01.01.2021. However, in order to adapt to the new requirements, the CE marking can continue to be used in most cases until the end of 2021. So far, the requirements of the UKCA marking are still relatively congruent with those of the CE marking. However, this will change. In contrast, it is still possible to sell to Northern Ireland under the terms of the CE marking.
What, in total, belongs to a product?
Within the EU, product law (e.g. General Product Safety Directive - GPSD) calls for the operating instructions and sales packaging of a product be considered in addition to the actual article when it is placed on the market. Advertising statements or online information relating to the product must also be taken into account.
Who is responsible for the product?
The person responsible for a product under the Product Safety Act is any manufacturer (natural or legal person) who manufactures a product or has it developed or manufactured and markets this product under its own name or trademark. The person responsible for a product is also considered to be someone who commercially applies that person’s name, trademark or other distinctive mark to a product and thereby claims to be the manufacturer, or who reprocesses a product or influences the safety properties of a consumer product and subsequently makes it available on the market.
What is governed by the Product Safety Act (ProdSG)?
The ProdSG is a piece of national (German) legislation and governs the safety requirements of technical work equipment and consumer products. It obliges the manufacturer of products to design them in such a manner that the safety and health of persons or other legal interests are not endangered when the products are used as intended or in a foreseeable manner.
What is a risk analysis and why do I need it?
A risk analysis is necessary for various reasons. The reasons may be the following:
- The risk analysis is required by law as part of product documentation, e.g. in accordance with the Low Voltage Directive 2014/35/EU, EMC Directive 2014/30/EU, Toy Directive 2009/48/EC, Machinery Directive 2006/42/EC, Medical Device Directive 93/42/EEC.
- The risk analysis shows which safety instructions are to be specified on the product, its packaging or operating instructions. It is recommended for all products (see LASI publication - LV 46 Guidelines to the Product Safety Act (ProdSG), 3rd revised edition 2013).
- The risk analysis also specifies which measures I, as the product manager, need to take in order to sufficiently reduce a determined product risk for a product that has already been sold. Measures may include the following: Customer information about the existing risks or even a recall of the product.
What must I do to implement the ProdSG (Product Safety Act) if I cannot find a suitable standard?
The ProdSG is what is referred to as a “catch-all law” that always applies. This is especially the case when other laws or EU directives/regulations do not apply. The question, of course, is how the ProdSG should be implemented if there are no harmonised or directly applicable product standards. In this case, it is always advisable to carry out a risk analysis and assessment for the product in question. The aim of the ProdSG is to guarantee human safety and health. It may turn out for simple products, for instance, that cuts caused by sharp corners are the only risk of injury; the implementation could then take place as part of a final inspection in the course of production.
What are product standards and how can I obtain them?
Product standards are voluntary standards developed by committees of the German standards authority DIN, the European standards organisations CEN/CENELEC or international standards organisations ISO/IEC according to defined principles, procedures and design and formulation rules. A product standard is a document that defines requirements for products, services or processes. It thus creates certainty regarding their characteristics, facilitates the free movement of goods and promotes exports. It supports rationalisation and quality assurance in business, technology, science and administration. A product standard serves to ensure the safety of people and property as well as the improvement of quality in all areas of life. The procurement of product standards is generally subject to a charge.The procurement of product standards is usually subject to costs. The company trade-e-bility GmbH has appropriate procurement channels and applies the standards that are important for your product.
What safety instructions do I have to indicate on the product, its packaging or in the operating instructions?
Safety instructions must indicate the existing risks in handling or dealing with the product. If standards are applied in order to guarantee the safety of a product, then these often refer to instructions that already must be affixed. However, these only apply to the scope of validity of the standard used, e.g. with regard to electrical safety. A complete list of all necessary safety instructions can only be obtained by means of a comprehensive risk analysis.
What are the consequences of incorrect product labelling or marking?
The labelling of the product is governed by law in the EU. Apart from origin and product identification, safety instructions must also be provided, for instance. If the product marking or labelling is faulty, then the sale may be prohibited by the competent public authorities. Moreover, injunctions may be claimed by competitors, which may give rise to enormous costs.
What is a marketability test?
This expression is not defined to be of general validity. trade-e-bility GmbH designates it to mean a review of the
- documentation and
- marking / labelling
of a product as regards proof that the records in question are complete and satisfy the legal requirements for consumer products to be placed on the market. Within the scope of statutory requirements, we examine aspects purely under product law such as safety, EMC (electromagnetic compatibility), chemical harmlessness, etc. Trademark law is not part of our offering. As a market area, we currently cover all EU and associated countries.
Is a product sample required for the marketability test?
As a rule, no product sample is required for the marketability test. However, we offer the following services only if a product sample is provided:
- Risk analysis
- Marking test, if the dimensions of the marking and the symbols are also to be assessed.
What documents are necessary for a marketability test?
It should be borne in mind that our statement on marketability is only as good as the data available to us! The required documents are individually different. If you have received an inspection plan, then you already have a list of the required documents in hand.
Depending on your assignment, however, we always require documents for
- Product safety
- Chemical harmlessness
- Layouts of product, packaging and operating instructions labelling (if labelling or marking inspection is part of our brief)
For electrical products, we require additional documentation for
- Electrical safety
- Electromagnetic compatibility (EMC or RED)
Further documentation may be required, depending on the product.
Allgemein Generally (always for every task),for filing in 00-Product description
|Artwork check for filing in 03-Artwork, BDA and nameplate|
|Document check, for filing in 02-Documents/Docu Check|
a. Electrical product (excl. radio):
d. Furniture/hard goods without electrical components
e. Radio equipment
For filing in 02-Documents/DOC
We generally require risk analyses and/or test reports. Certificates usually do not provide the required information!