The central legal concept for the safety of products is product conformity or produkt compliance. It is relevant throughout the EU not only for manufacturers, importers and distributors, but also for market surveillance.
In this article you will find explanations and information on the following issues:
Anyone who deals with the safety of products, whether electrical appliances or toys, machines or protective equipment, will very quickly come across the term “conformity”. This term is otherwise more commonly used in psychology, for example when describing phenomena such as peer pressure. Conformity here refers to the agreement of an individual with the opinion, values or world view of a group or majority.
Product safety law is also about conformity. A specific (individual) product should comply with the higher-level requirements for its product group. If this conformity does not exist, the product is considered “non-compliant” and must be withdrawn from the market or may not be placed on the market in the first place.
The conformity of a product marketed in the EU does not refer to opinions, but to essential safety objectives that are defined in European directives and specified or implemented by technical standards. In terms of meaning, these requirements are of course based on values, namely the safety and health of people as users of the product.
Irrespective of the criteria of safety and health, the term conformity can also refer to other requirements, such as environmental protection, climate protection or data protection, both for a product and a service.
The highest maxim in European product safety law is the responsibility of the manufacturer. The manufacturer of a product may only place safe products on the European internal market. They must determine the safety of each of their products in a risk assessment, document this and – for many, but not all, product groups – declare it with the CE marking.
Figure 1: CE-relevant regulations in Europe
Source: Own compilation
The manufacturer’s responsibility does not end with the sale of the product, as the obligation to monitor the product applies. If the manufacturer becomes aware that, contrary to expectations and despite risk assessment and conformity assessment procedures, one of his products endangers the health and safety of the user, he must react and do everything possible to avert this danger. This ranges from informing the authorities and publishing product warnings to withdrawal and recall campaigns.
In addition to the manufacturing companies, the manufacturers, many legal texts on product safety address other economic operators. These include authorized representatives (of the manufacturer), importers and distributors. These groups involved in market activities are defined in the Product Safety Act (ProdSG). The new Market Surveillance Ordinance, which came into force in July 2021, now also includes online marketplaces and fulfillment centers in this responsibility for product safety.
In addition, the new Product Safety Regulation (EU) 2023/988 creates the need for manufacturers to register in the new EU Safety Business Gate. This enables manufacturers to submit a notification to the competent authorities as quickly as possible as soon as they become aware of a dangerous product.
Retailers and operators of online marketplaces are also required to register buyers’ data for safety reports and warnings. It is important to note that this data may not be used for commercial purposes.
The most important step in proving the conformity of a product is to be guided by the (harmonized) standards applicable to the product. This is because the European directives as well as the legally binding national laws and regulations can only roughly and fundamentally outline the health and safety requirements. The more detailed design of the safety-relevant technical properties of a product is carried out through standardization.
Standards are published by private standards organizations and are generally not legally binding. Many of the standards relevant within the EU are developed in the Technical Committees (TCs) of the European standardization organizations (CEN, CENELEC, ETSI). Their requirements are generally adopted unchanged in national standards.
The organizations involved in standardization in the German-speaking world are DIN (German Institute for Standardization), the Swiss Association for Standardization (SNV) and Austrian Standards International (A.S.I.), the former Austrian Standards Institute. Globally relevant standards can be recognized by the abbreviations ISO, IEC or ITU. These stand for the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC) and the International Telecommunication Union (ITU).
Presumption of conformity is a legal term that may seem somewhat vague at first glance, but it can be very important in the event of a conflict. The presumption of conformity applies to so-called harmonized standards. These are standards that have been adopted by a European standardization organization in accordance with a defined procedure and published in the Official Journal of the EU.
These standards are considered to be the state of the art within the EU, as stated in section 4.1.2.4. of the 2022 Blue Guide. The accreditation of a testing laboratory is therefore regarded as proof that the competence to comply with this state of the art is available at this testing laboratory.
If, following an injury or other case of damage during the use of a product, proceedings are brought for liability claims, compensation etc., the manufacturer must demonstrate how he has ensured that his product meets the mandatory safety requirements.
If he proves that he has fulfilled all the requirements of the harmonized standards that apply to his product, the court assumes (in favour of the manufacturer) that he has also fulfilled the overriding requirements of EU product safety law.
This does not change the fact that the manufacturer must still make the necessary changes if the product poses a risk. If it turns out that the manufacturer has not acted in accordance with the normative requirements relevant to the product, this alone does not constitute a breach of the law. However, it may be more difficult for the manufacturer to plausibly demonstrate in court how it intended to achieve the same level of safety according to its own chosen criteria
From the manufacturer’s point of view, the presumption of conformity of harmonized standards can therefore mean a gain in legal certainty. This is also because, in legal proceedings, the burden of proof for a breach of the health and safety requirements lies with the plaintiff or the market surveillance authorities involved.
This is because, to put it simply, the court initially assumes (= presumes) that a manufacturer who complies with the harmonized standards has done everything correctly until proven otherwise.
A conformity assessment procedure is a process for checking, evaluating and documenting the conformity of the safety properties of a product with the requirements applicable to the product group. If successful, the conformity assessment ends with the declaration of conformity and the marking of conformity on the product by affixing the CE mark.
Depending on the product group (machinery, medical devices, protective equipment, electrical equipment, etc.), the applicable European directive or regulation specifies how the conformity assessment procedure is to be carried out. The process can essentially be based on an internal production control, but can also require an EU type examination or even include an external examination by an independent body (notified body). The exact procedure is specified by so-called modules in the relevant applicable harmonized EU legislation.
Many EU directives require the manufacturer to prepare a risk assessment (sometimes also referred to as a risk analysis) for a new product. It is considered the core element of the conformity assessment procedure. This risk assessment should determine all risks and hazards posed by a product, identify the necessary and applicable standards and check whether the protection objectives are met on the basis of the applicable directives and the identified standards. The assessment of a risk must not only take into account the possible extent of damage, but also the probability of its occurrence.
Based on the risk assessment, the manufacturer must implement risk reduction measures and define the limits of product use. The manufacturer must draw attention to residual risks that cannot be avoided by design measures in his technical documentation, in particular in the information intended for the user, such as operating instructions or instructions for use.
The EU Declaration of Conformity is a written document at the end of the conformity procedure. The manufacturer thereby declares that his product fulfills the applicable safety, health and environmental protection requirements. The drawing up of an EU declaration of conformity is always linked to the affixing of a CE marking on the product. Both processes may only be carried out once the conformity assessment procedure has been completed and conformity has been successfully demonstrated.
For a product that is covered by several EU directives, the conformity assessment must be carried out in accordance with each of the applicable directives. However, only one declaration of conformity may be issued for each product. This can either consist of a declaration that lists all the requirements or comprise one page per legal regulation, which then constitute the EU declaration of conformity in a folder, for example.
Figure 2: Exemplary EU declaration of conformity of a toaster in German language (status: July 2021)
Written information for the future user is essential for all product groups that require a minimum of explanation. Technical documentation primarily includes the operating instructions or instructions for use familiar from everyday private life.
Operating instructions should provide information on the correct and therefore safe use of the product. It indicates the limits of use, e.g. that an electrical product may only be used in dry conditions and never outdoors, and provides information on care, maintenance and disposal.
There are often extensive text specifications or necessary information in the applicable standards, which are essential for compliance with these standards. An example of this is that there must be a minimum distance between a raclette / toaster and a curtain or wall and this information is required in the instructions.
However, the user information is only one part of the technical documentation. In addition to this external technical documentation, the internal documentation, i.e. the documentation that remains with the manufacturer, includes many other documents such as parts lists, bills of materials, bills of substances, design drawings, circuit diagrams, test reports, information on the production process, risk analyses, inspection documents, etc., depending on the product.
The letters CE stand for “Conformité Européenne” (European Conformity). CE marking is required by various directives, e.g. the Low Voltage Directive (LVD) or the Electromagnetic Compatibility Directive (EMC) and is the responsibility of the manufacturer for most products.
The manufacturer is thus solely responsible for confirming that the prescribed conformity assessment procedures – as described in the directives applicable to the product – have been applied and fulfilled.
In contrast to many quality and environmental labels, CE marking is in no way voluntary. The legal framework here is clear and strict and only provides for two cases:
The manufacturer therefore has no choice. Either he must affix the CE marking or he may not affix it at all. In the case of products that fall under the scope of several CE directives, the CE marking is nevertheless affixed only once.
The question of whether a product must bear a CE marking or not is not always easy to answer in practice. A simple glue stick does not generally fall under a CE regulation and therefore may not bear a CE marking. However, if this glue stick is designed in such a way that children find it attractive (e.g. through its colorful design with small animal figures), the authorities can argue that this product is a toy and is therefore subject to the Toy Safety Directive.
The consequence of this argument would be that the glue stick would have to be tested according to various standards of the Toy Safety Directive (e.g. EN 71-1, EN 71-2, …) and a CE marking on the product would be mandatory. Similar discussions and even lawsuits have already been held for many decorative items if these decorative items depict animals or are attractive to children (“child appealing”) and are or have therefore been classified as toys by the authorities.
The CE marking must generally be affixed to the product and its packaging. The shape and size are prescribed, and the CE marking must also be visible, legible and permanently affixed. For very small products in particular (e.g. USB sticks, individual cable ties or nails), it is sometimes not possible to affix the CE marking and is therefore also permitted on the packaging.
Depending on the product, the CE marking may be accompanied by many other mandatory labeling elements such as the name and address of the manufacturer, product identification information, technical specifications, size information or instructions for use and warnings.
However, a complete and correct EU Declaration of Conformity does not mean that the product is legally compliant. This legal conformity is often also referred to as marketability. In addition to the CE regulations for the individual products, there are other country-specific and European regulations that a product must fulfill in order to be legally compliant.
These include, for example, the REACH and POP Regulations ((EC) No. 1907/2006 and (EU) 2019/1021 and their numerous amendments), which prohibit or regulate the presence or content of certain chemical substances in products.
The European Deforestation Regulation (EU) 2023/1115, the Conflict Minerals Regulation ((EU) 2017/821) or the various national disposal and labeling obligations must also be observed for certain products. Only when a product meets these additional regulations and complies with them on a permanent basis is full legal conformity and marketability guaranteed.
As already described, there are detailed directives and regulations for many product groups (machines, toys, electronic products, etc.) in the EU to ensure the safety of products and to define how the conformity assessment procedure should be carried out.
However, many products are not harmonized throughout Europe and are not subject to any European product-specific (CE) directives or regulations. These include, for example, many consumer goods such as plates, cups or cutlery, but also many items of furniture, decorative items, items of clothing, bicycles and much more.
For these products, however, there are usually national regulations that the product must fulfill in order to be marketed in the respective country. Examples of this in Germany include the LFGB (German Food, Commodities and Feed Code), which must be taken into account especially for products that come into contact with food or have prolonged skin contact.
In the case of clothing, the Textile Labeling Regulation ((EU) 1007/2011) and the Chemicals Prohibition Regulation must also be taken into account. However, the new Product Safety Regulation also extends the requirements for manufacturers and importers in particular to products that are not regulated by CE regulations.
As there is only a mandatory EU declaration of conformity for so-called CE products, the creation of a general declaration of conformity for non-CE products is not necessarily intended and there are no content or formal requirements for this.
However, as many retail customers also want a declaration of conformity from the manufacturer or importer for non-CE products, voluntary self-declarations for the conformity of the products are an option here. These can then refer to the regulations and standards applied to this product.
Particularly important here is the requirement for permanent compliance with legal requirements. In today’s fast-moving world, it is not unusual for components or materials in a series product to change over time: Components are no longer available, the upstream supplier has changed suppliers, materials change or small electronic components are replaced by newer ones.
From a legal perspective, this results in new products that are generally no longer identical to the originally tested product variant. Very often, the new variants are then no longer compliant with the regulations applicable to this product.
As the regulations and standards are also changing at ever shorter intervals to reflect the current state of the art, series products actually have to be continuously checked for compliance (with every delivery). Particularly in the case of chemical regulations (e.g. REACH), the requirements often change twice a year, as additional hazardous substances are added to the so-called candidate list.
In order to ensure conformity, it must be checked whether and in what quantities the new substances are present in the product and whether they may violate Annex XVII of the REACH Regulation. In order to ensure formal conformity, the corresponding documentation should also be revised and it should be clear from the documentation that all substances on the updated candidate list have been checked for this product.
You can find a detailed explanation of how compliance can be maintained for serial products in our separate magazine article “Product compliance for series products – solving the documentation dilemma”
Government agencies monitor market activity at national and international level. Market surveillance authorities are responsible for checking whether products on the market or imported products comply with the laws and regulations applicable within the EU.
In Germany, market surveillance tasks are carried out by various authorities and organizations, including the Federal Ministry of Labour and Social Affairs (BMAS) with the Federal Institute for Occupational Safety and Health and the Federal Ministry for Economic Affairs and Energy (BMWi) with the German Market Surveillance Forum (DMÜF). In addition, there are various specialist authorities such as the Federal Office of Consumer Protection and Food Safety (BVL) or the Federal Motor Transport Authority (KBA) as well as the state authorities.
In the area of electronic products, the Federal Network Agency monitors compliance with the Electromagnetic Compatibility of Products Directive (EMC Directive – 2014/30/EU) and the RED Directive (Radio Equipment Directive – 2014/53/EU) in particular. The review of the other CE directives and their requirements is generally the responsibility of the respective state authorities in the individual federal states.
Figure 3: Market surveillance authorities in Germany according to the German Market Surveillance Forum in June 2024
Source: https://www.bundesnetzagentur.de/DE/Fachthemen/Telekommunikation/Technik/DMUEF/start.html
The EU operates a rapid alert system called Safety Gate, formerly known as the RAPEX system (Rapid Exchange of Information System), to inform each other about dangerous products in individual member states. This system is intended to give market surveillance authorities and consumers throughout the EU the opportunity to obtain neutral and independent information about dangerous products.
For Germany, the Federal Institute for Occupational Safety and Health (BAuA) maintains the “Dangerous Products” database. Current product warnings, recalls, prohibition orders etc. can be researched there. Anyone can access the database free of charge at www.rueckrufe.de.
In the event of suspected safety deficiencies or breaches of fair competition, the authorities have the right to prohibit a product from being placed on the market. If the product has already been made available on the market, the authorities can order a recall, withdrawal and/or retesting of the offending product.
Employees of the market surveillance authorities have further powers when dealing with manufacturing or importing companies. They may enter business premises, inspect products and impose fines. In addition to the consequences under regulatory offense law, violations of product safety law can have consequences under criminal and civil law.
Depending on the product group, the respective health and safety requirements have been defined in separate guidelines. This is because different specifications and standards must be observed for the safety of a toy than for the safety of a blender or a respirator mask, for example.
However, there are also some serious differences within the product groups in terms of the legal requirements, as the technical specifications, the complexity of the product, the materials, the areas of application and, above all, the target groups can differ greatly.
For example, there are different requirements for puzzles with less than 500 pieces than for puzzles with more than 500 pieces. Puzzles with less than 500 pieces are considered toys, while puzzles with more than 500 pieces are considered entertainment products for adults. According to the Toy Safety Directive, only children under the age of 14 “play”; products for adults are not considered toys within the meaning of the Directive.
Ultimately, the manufacturer or importer must analyze each individual product in detail and also include the expected and possible usage situation as well as the users in the considerations in order to make an adequate assessment of the potential risk and the applicable standards and tests. The following questions must also often be asked and answered within a product group:
To illustrate the different requirements for different product groups, we explain below some of the conformity requirements for electrical products, toys and protective equipment.
The Low Voltage Directive 2014/35/EU, the EMC Directive 2014/30/EU on electromagnetic compatibility and the Radio Equipment Directive 2014/53/EU (RED) are generally relevant for electrical appliances. Larger electrical products such as washing machines, refrigerators and TVs, as well as light sources and external power supply units, are also subject to the Ecodesign Directive 2009/125/EC, which has been integrated into the Energy Consumption-Related Products Act (EVPG) in Germany.
In addition, the provisions of the RoHS Directive 2011/65/EU (RoHS 2) and the WEEE Directive 2012/19/EU on waste electrical and electronic equipment must be observed. As the products are usually packaged, the requirements of the respective national packaging regulations (Packaging Act) must also be observed for almost all products. In addition to these clearly regulated product-specific requirements, electrical products must of course also comply with the cross-product REACH and POP regulations.
The fact that electrical appliances in particular are often non-compliant and can very often cause electric shocks, burns and fires becomes clear when analyzing the entries of dangerous products in the European Union’s Safety Gate. A large number of small household appliances (e.g. kettles, hair dryers), chargers or power strips regularly appear here, which have to be withdrawn from the market or even recalled due to design defects, poor choice of materials or poor production quality. These products often violate the Low Voltage Directive and the European standards EN 60335-1, EN 62368-1, EN 60598-1 and others.
Toys are treated separately in European product safety law. This is because special requirements apply to products that are specifically aimed at children and are used by children. Children cannot be expected to recognize dangers and risks or even read operating instructions.
The Toy Safety Directive 2009/48/EC and the German Toy Safety Ordinance (Verordnung über die Sicherheit von Spielzeug), also known as the 2nd Product Safety Ordinance (2. ProdSV), are decisive here. To prove conformity with the European requirements, tests in accordance with various standards in the EN 71 series of standards are prescribed or recommended.
The standards EN 71-1, EN 71-2 and EN 71-3 focus on the general requirements for all toys (mechanical and physical properties, flammability and migration of certain elements), while the other standards (EN 71-4 to EN 71-14) regulate the specific requirements for individual products or product groups (e.g. experiment kits, finger paints, trampolines).
Toys also appear time and again in the European Union’s Safety Gate. The risks for children here are usually choking hazards due to small parts coming loose, strangulation hazards due to cords or straps and hazardous chemical substances, the presence of which in toys is much more strictly regulated than in other products.
The conformity of toys also includes correct labeling, as the Toy Safety Directive contains very specific labeling requirements for various products or applications (e.g. “Not suitable for children under 36 months” or “Use under the direct supervision of adults”).
It should also be noted that the packaging of the toys is also part of the product and this packaging must also comply with the applicable European regulations such as REACH or POP. This aspect should not be underestimated, as the packaging of the products is often not tested, but the market surveillance authorities can very easily detect prohibited substances in the packaging using so-called XRF scanners.
Electronic toys, which are brought onto the market in numerous variations, are extremely demanding in terms of regulation. For example, remote-controlled toy cars or plush figures that can make noises or movements when controlled by a smartphone via Bluetooth are not only subject to the Toy Safety Directive, but also to the relevant electronic requirements (e.g. Low Voltage Directive, EMC Directive, Ecodesign Directive, RoHS, RED, …). Proof of conformity for such products can easily entail tests worth several thousand euros.
Personal protective equipment (PPE) is the generic term for all clothing and equipment components that protect the body from head to toe against injuries and health hazards. Regulation (EU) 2016/425 on personal protective equipment is authoritative. From the manufacturer’s perspective, the distinction between PPE and medical devices is relevant, as the latter are subject to their own provisions under the Medical Devices Regulation (EU) 2017/745.
This recently became clear during the coronavirus pandemic. The distinction between the various products for mouth and nose protection and respiratory protection was not always clearly recognizable. In principle, a respirator is considered PPE if it is intended to protect its wearer.
A classic example is an FFP2 mask for highly dusty activities. However, if a respirator is worn to protect a patient, for example from infection by operating room staff, then this mask is considered a medical device.
The classification is therefore not necessarily based on the product (in this case the mask) and its design, but on the intended use. It is perfectly possible to declare a product both as protective equipment and as a medical device, provided the manufacturer takes both sets of regulations into account.
According to Regulation (EU) 2016/425, the components of PPE are divided into three categories: I, II and III. The higher the category, the greater the protective function, but the requirements for production control and quality assurance also increase.
Ensuring long-term product compliance is a very complex task for manufacturers, importers and retailers, especially given the current speed of new product launches and the increasing breadth of the product range.
At the same time, the topics of product safety, sustainability and environmental protection, as well as the social requirements for the entire value chain (keyword: Supply Chain Act) are becoming increasingly important.
Ensuring product and social compliance will therefore require the companies involved to deal much more intensively with the diverse legal requirements in future and to build up the corresponding expertise and adequate resources.
