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Mastering challenges:
Lack of product compliance knowledge

The large number of legal regulations and their frequent changes and tightening make it extremely time-consuming for companies to know and take into account all requirements. This is particularly the case when companies have a broad product range and are active in numerous countries.
The large number of applicable standards, regulations for packaging and labeling, different risk aspects and adequate test procedures and inspections also require expertise and experience that is not sufficiently available in many companies.

European and national regulations

European regulations exist for numerous product groups, which are either directly applicable in all member states (regulations) or implemented in national laws (directives). These regulations are updated at irregular intervals and the scope of application and requirements are sometimes massively changed. Examples of this are the Toy Regulation, the Machinery Regulation or the Ecodesign Regulation, which will replace or have already replaced the older directives.

In addition, there are numerous national regulations for non-harmonized product areas in the various countries, which are generally only published in the respective national language. These include, for example, many consumer goods such as plates, cups or cutlery, but also many items of furniture, decorative items, clothing, bicycles and much more. Compiling all the regulations that apply to the various products is anything but easy, especially with a broad and heterogeneous product range.

European and international standards

Another challenge for companies with a wide range of products and numerous sales countries is knowledge of national, European and international standards. For almost every product, there are standards in the individual countries or regions that describe test methods that are necessary for the safety assessment of the product in question.

They may, for example, cover mechanical safety, flammability or the protective effect of a product. There are also standards for testing the chemical safety of a material or product. The difficulty of knowing all the relevant standards is due to the fact that there are over 34,000 different DIN standards in Germany alone, with around 2,500 new standards being published or revised every year.

The following example from the mechanical engineering sector shows why knowledge of the standards is an important prerequisite for product conformity in different countries: In Germany, the emergency stop buttons on grinding machines must be mounted at a height of 1.10 to 1.30 meters, whereas in the USA they must be mounted at a height of 0.90 to 1.10 meters.

A manufacturer of grinding machines would not be allowed to sell the machines for the German market in the USA, as they do not comply with the standards there. According to experts, these and many other differences in standards between the USA and Europe result in additional costs of 4 to 5%

Harmonized and non-harmonized standards

A European standard forms a uniform technical language for the EU economic area and is the preferred tool in the EU's harmonization efforts.
A harmonized standard is a European standard that covers all or part of the protection objectives of the underlying legislation and has been commissioned for this purpose by the EU from a standardization body. In this sense, a harmonized standard means that the technical requirements described in this standard are uniform for the entire economic area of the EU.

This approach means that manufacturing a product according to the specifications of a harmonized standard triggers the so-called presumption of conformity. The presumption of conformity describes the special circumstance that it is assumed that the product fulfills the relevant valid safety parameters. If authorities object to this, you must prove that this is not the case.

In contrast, non-harmonized European standards do not trigger this presumption of conformity and the burden of proof lies with the manufacturer. This is another reason why it is necessary to know the relevant and current standards for the respective products - and this is anything but easy, especially with a wide range of products.

Regulations for packaging and labeling of products

In addition to regulations for various products (electrical appliances, toys, furniture, etc.), companies must also take into account numerous regulations for packaging and labeling. The packaging of a consumer product is part of the product and is therefore subject not only to the REACH Regulation, but also to the Packaging Ordinance adopted in 2024. The Packaging Ordinance sets out requirements for substances in packaging and their recyclability, in particular the restrictions on concentrations of lead, cadmium, mercury and hexavalent chromium (hexavalent chromium, chromium XI).

The use and concentration of these substances of concern in packaging material or packaging components should be minimized during production. This also applies to their presence in emissions, all materials resulting from waste management and secondary raw materials (e.g. ash or other materials that are to be disposed of).

Numerous requirements must also be taken into account when labeling products. The Product Safety Regulation and the various product-specific directives or regulations stipulate detailed information that must be affixed to the product or packaging. For substances and mixtures, the CLP Regulation (CLP = Classification, Labelling and Packaging) is also decisive, which requires very specific specifications to be adopted verbatim in the individual national languages of the EU for hazard pictograms, signal words and hazard and safety information (H and P phrases).

Many companies are not aware of these packaging and labeling requirements and this is the cause of numerous import delays or sales bans.

Prioritization of product compliance risks

With a wide range of products, it is very difficult to know, comply with and document all requirements for all products sold. Prioritizing measures is therefore strongly recommended in order to gradually approach the goal of minimizing risk.

However, many of our customers are unsure about which risks emanate from which products and how they should be assessed. We regularly discuss and answer the following questions in our customer workshops:

- Which product categories pose the greatest risks?
- Which materials pose which risks?
- What risks do own brands and private labels pose?
- What influence does the number of products sold have on my product compliance risk?
- Are there different risks in different European countries?
- Which products are disproportionately monitored and checked by market surveillance authorities?
- What influence do the number, locations and quality of my suppliers have on my product compliance risk?
- What influence does the sales strategy have on my product compliance risk?

Test procedures and tests to demonstrate product conformity

In order to prove the conformity of different products, various product or material tests are usually required, which should be carried out by independent testing institutes. Without knowing which standards are relevant for their products and which test methods are necessary and appropriate, companies often have difficulties selecting or commissioning the right test methods.

It often happens that companies receive different test methods and often completely different offers from different testing institutes. As a rule, the decision then lies with the company and the testing institute assumes no liability that the selected method actually confirms the conformity of the product. In addition, the test report often states that the testing institute carried out the test on the instructions of the customer, thereby evading any responsibility.

Without the know-how about appropriate testing methods and their costs, it is difficult to establish efficient and cost-effective product compliance management.

Market overview of testing institutes

As mentioned above, product and material testing is essential for proving the conformity of most products. However, small and medium-sized companies (e.g. e-commerce providers) in particular face major challenges when it comes to obtaining a comprehensive market overview of the various testing institutes that test products and materials for conformity in different countries. The variety of existing testing institutes and the different requirements in the respective regions make this task considerably more difficult.

It is estimated that there are over 15,000 testing institutes worldwide, of which around 5,500 are located in Asia, 5,000 in the USA and Canada and 4,500 in Europe. These figures illustrate the enormous number of players in the market for testing and certification services, which makes it difficult for medium-sized companies to gain an overview of the market.

The testing institutes differ not only in their regional distribution, but also in their areas of specialization. Certain institutes have specialized in specific product areas, which makes choosing the right partner even more complex for companies. It is often necessary or expedient to work with different testing institutes for different products.

Testing laboratories in North America have their strengths in the areas of electronic products, medical products and the automotive industry, while testing institutes in Europe are known for the textiles, chemicals and mechanical engineering sectors. The test laboratories in Asia have concentrated strongly on the product areas of consumer goods, toys and electronic products, as a large proportion of products from these sectors are produced in Asia.

The difficulty of gaining a comprehensive market overview is further exacerbated by the different legal requirements and standards in the various countries. Products that are to be sold in several markets often have to undergo various test procedures, each of which corresponds to specific national or regional standards.

For example, textiles have different fire safety requirements and chemical regulations in the USA, the EU and Asia. For electronic products, safety and EMC (electromagnetic compatibility) requirements differ in the three regions, and medical products also have different, very strict regulatory requirements in the USA, Europe and Asia.

Selection and management of attractive testing institutes

Another important aspect is the difficulty in assessing the quality and reliability of the various testing laboratories. There is often a lack of transparent and comparable quality standards, which makes it difficult for companies to objectively assess the performance of the various institutes. This can lead to uncertainties and risks when selecting suitable testing laboratories and impair quality assurance within the company.

A first point of contact for Europe can be the EU's so-called NANDO list (Nando = New Approach Notified and Designated Organizations), which lists the notified bodies for various product groups by member state and where companies can be fairly certain of receiving a competent service.

However, it should be borne in mind that testing laboratories tend to focus on large customers such as large discounters in order to carry out as many of the laboratory tests, inspections or audits as possible for them. Medium-sized or small companies that only wish to purchase services irregularly and not on a large scale are generally not considered a priority target group. This prioritization has various negative effects on medium-sized customers.

Firstly, this focus is often reflected in inadequate service. Large customers generally receive preferential treatment, faster processing times and individually tailored services. Medium-sized companies, on the other hand, often have to put up with longer waiting times and do not receive the same level of personal attention and flexibility. This can significantly delay the audit process for SMEs and disrupt their operational processes.

Secondly, the lack of prioritization of medium-sized customers is also reflected in the price level. Testing laboratories often offer large customers attractive discounts and special conditions that are not available to small and medium-sized companies. As a result, SMEs have to bear comparatively higher costs, which can affect their competitiveness.

Cooperation with different testing laboratories also poses a considerable challenge for SMEs. On the one hand, parallel cooperation with several institutes requires extensive coordination and a high level of administrative effort. This ties up valuable resources, which are often in short supply, especially in medium-sized companies.

Secondly, language and cultural barriers often arise when the testing institutes are located in different countries or regions. These barriers can make communication difficult and promote misunderstandings, which delays and complicates the entire inspection process.

Ultimately, medium-sized companies are often less experienced in managing test houses, as this is not one of their core competencies and the services of test laboratories are often only commissioned on an irregular basis.

Solution approaches from trinasco

trinasco GmbH has a very good overview of the market and has contacts with numerous renowned testing laboratories in Germany and abroad. In addition, we cooperate with a company through which the offers of numerous test laboratories can be obtained and evaluated. As this partner works for numerous large trading companies, it receives very attractive offers and implementation deadlines from which smaller customers can also benefit.

Our references

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