The European Union’s single market is the largest in the world, ahead of China and the US.
It’s easy to understand why Europe is an attractive destination for so many sellers based in member states and merchants from around the globe.
Still, the path to the EU’s marketplaces isn’t straightforward because businesses must ensure that each product meets stringent product safety standards.
Whether you’re the manufacturer, importer, or distributor, determining which regulations, directives, and standards apply to the items you want to place on a European marketplace can be incredibly complex.
So, in this guide, we’ll walk you through the essential product safety standards to help you determine your responsibilities and the steps you must take to bring your products into compliance before offering them to European consumers.
The overview of the European safety standards
According to the European Committee for Standardization (CEN), a standard is:
‘A technical document designed to be used as a rule, guideline, or definition. It is a consensus-built, repeatable way of doing something. Standards are created by bringing together all interested parties, such as manufacturers, consumers, and regulators of a particular material, product, process, or service.’
Standards are created for regulatory purposes and to ensure all products meet the necessary performance requirements.
Directives and regulations, like the GPSR, are the backbone of the European standardization system that commonly list general requirements that products on the EU marketplace must meet.
Although these documents indicate that all economic operators, regardless of the industry, must adhere to product standards, they rarely reference a particular standard that applies to a certain category of products.
For instance, Article 6 of the GPSR lists the aspects manufacturers and other economic operators must consider when assessing a product’s safety. However, it doesn’t mention specific standards a product must meet.
Most consumer products must meet the so-called European Standards (EN), which are implemented by 34 countries, including the EU member states.
However, determining whether the EN 301 549 standard applies to a specific digital product or whether the toy your company produces meets the EN 71 standard can be difficult if you’re unfamiliar with European Standards.
Identifying applicable regulations and directives
The European Union has a wide range of directives and regulations that govern all aspects of the safety of products entering its markets, which makes it challenging for economic operators to determine the particular requirements their products must meet before entering the European marketplace.
The General Product Safety Regulation presents a legal framework that determines the responsibilities of economic operators offering consumer products on the EU’s offline and online marketplaces.
This regulatory framework doesn’t apply to certain categories of products, like antiques and artwork, medicinal, or animal feed. Some product categories that fall under the scope of the GPSR, like toys, are also covered by other directives such as the Toy Safety Directive.
Nonetheless, products excluded from the GPSR are covered by other EU product safety regulations, directives, and national standards.
Here’s a brief overview of EU legislation that could potentially apply to the products that sellers place on online marketplaces:
- Cosmetics regulation
- Legal framework for governing medicinal products for human and veterinary use
- Restriction of Hazardous Substances (RoHS)
- Radio Equipment Directive (RED)
- Low Voltage Directive (LVD)
- Electromagnetic Compatibility (EMC) Directive
- Ecodesign for Sustainable Products Regulations
Please bear in mind that the above list isn’t conclusive and that other directives and regulations may apply to the products you’d like to offer on European marketplaces.
The first step towards compliance with EU product safety standards is determining which regulations and directives apply to your products.
The differences between harmonized and non-harmonized standards
Most of the above-mentioned EU directives and regulations reference different standards, although these documents often don’t contain direct references to harmonized or non-harmonized standards that apply to specific product categories.
Consequently, manufacturers, importers, and sometimes distributors must search for specific standards that apply to the products they want to offer in the EU.
Let’s take a closer look at what harmonized and non-harmonized standards are and the differences between them.
Harmonized standards
Harmonized or the so-called European Standards are developed by European Standardization Organizations such as the CEN or ETSI and published in the official journal of the European Union.
They are applicable in all member states, but their use is often voluntary because manufacturers can opt to demonstrate compliance with safety regulations in other ways.
However, the adherence to technical requirements laid out in relevant directives and regulations is mandatory for all economic operators.
Additionally, EN standards guarantee the presumption of conformity with relevant product safety regulations and guidelines, and indicate the item’s conformity with basic safety and risk management processes.
Harmonized standards are fee-based and can be purchased from the national standardization and conformity assessment bodies of EU member states. Still, it’s worth noting that some standardization organizations offer EN standards free of charge.
Non-harmonized standards
European Standards don’t cover all types of products, and in some cases, these standards are only partially applicable to certain products.
However, importers and manufacturers can rely on non-harmonized standards to meet the compliance requirements and satisfy the necessary criteria for conformity assessment.
Non-harmonized standards aren’t published in the official journal of the European Union.
Consequently, they cannot be used to demonstrate presumption of conformity automatically, although they can serve as evidence of compliance and an item’s essential performance capabilities, which complicates the process of obtaining the necessary documentation required to place a product on an EU marketplace.
Some standards with the EN abbreviation, like the EN 1888, are non-harmonized, while some ISO standards that are commonly non-harmonized are harmonized.
Here’s a brief overview of frequently used non-harmonized standards:
- UL standards
- ASTM standards
- ISO and IEC standards
It’s also worth noting that national product safety standards of EU member states are not always harmonized, and they may be insufficient to qualify for the presumption of conformity automatically.
What should you do if there are no applicable harmonized standards for your products?
The European Standards are not available for all types of products on European marketplaces. However, these products aren’t exempt from meeting the safety requirements due to the absence of an applicable harmonized standard.
As a result, the item’s manufacturer or importer must choose an alternative technical solution to achieve compliance with applicable directives and regulations.
Using non-harmonized standards, like ISO or ASTM, is often the simplest solution, but these standards are usually the starting point toward full compliance.
Additionally, manufacturers and importers may have to collaborate with third-party consulting companies and testing laboratories to find a suitable compliance solution for their products.
A glance at CE marking requirements
European Conformity (Conformité Européenne) markings indicate that the product’s manufacturer assumes responsibility for its conformity with safety, health, performance, and environmental standards.
In most cases, products that require CE marking must comply with the EU’s harmonized standards.
Importers and manufacturers must affix this marking to products from certain categories, such as toys, eyewear, or electronics. However, there are over thirty CE marking regulations and directives covering a broad range of products, and this number will likely increase in the future.
These directives and regulations don’t always include the specific products they cover, and often only list the technical attributes, like a device’s input and output voltage range. Hence, determining which products need CE marking can be difficult.
Moreover, the EU prohibits placing CE markings on products that don’t fall under the scope of legislation that mandates the use of these markings for a certain type of product.
Consequently, economic operators must determine whether their products need CE marking and meet the specific requirements, such as conformity with harmonized standards, necessary technical documentation, or the Declaration of Conformity (DoC).
Meeting the labelling requirements
Besides adding appropriate markings that are commonly printed on the product, manufacturers must also ensure that each item they offer in the EU has appropriate labels.
Still, understanding the difference between the two can be tricky. Markings are symbols or pictograms that provide market surveillance authorities, consumers, distributors, and importers with information about a product’s safety, environmental impact, or energy efficiency.
Conversely, labels usually contain more specific information about a product, such as the manufacturer’s name and address, tracking data, technical specifications, description of the item’s physical properties, or a list of the materials used to manufacture the item.
The General Product Safety Regulation has expanded the list of information that product labels must contain. So, in addition to the manufacturer’s name and contact details, the label must also include the name and contact information of the product’s EU Responsible Person.
Most importantly, all information included on a product label must be accurate, as providing consumers or market surveillance authorities with misleading information can lead to penalties and product bans.
Compliance as the entryway to European digital marketplaces
Online sellers trying to establish a lasting presence on online marketplaces in the EU must follow the Union’s strict product compliance rules.
The EU’s new product safety regulation mandates that manufacturers must conduct internal safety assessments of the items they want to make available to consumers in member states.
However, this isn’t the only EU legislation that lays out the technical requirements products must meet before being placed on online or offline markets in the EU. Manufacturers, importers, or distributors must also ensure that each item they offer to European consumers meets the criteria presented in the relevant regulations and directives.
Ensuring that each product you want to add to your online store in the EU is time-consuming. Get in touch to find out how Webinterpret can help you automate this process.
About Webinterpret
Webinterpret supports merchants selling on eBay.
Our AI-based solutions enable more effective selling through automated listing localization, advertising, and returns and ensure all products placed on EU markets are GPSR-compliant.
By giving your international customers a full, end-to-end local shopping experience, Webinterpret improves your conversion and helps establish your business globally.
