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Product Regulations in the European Union: A Beginner’s Guide

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Product regulations, such as safety standards and labeling requirements, are mostly ‘harmonized’ in the European Union.

As such, the same regulations apply in all member states. A product that is compliant in the United Kingdom, is therefore also compliant in Poland and Italy.

The European Union has arguably the most developed set of product regulations, covering essentially every product category from electronics and toys – to textiles and furniture.

In some cases, it’s only a matter of ensuring compliance with simple labeling requirements, while compliance for other products require lab testing and plenty of documentation.

In this article, we explain what startups and ecommerce companies must know, before importing products to the European Union.

European Union (EN) Product Safety Standards

The EU has developed standards that apply to specific products, materials or components. Below follows a few examples:

  • EN 54: Fire detection and fire alarm systems
  • EN 71: Safety of toys
  • EN 166: Personal eye protection. Specifications
  • EN 374: Protective gloves against chemicals and micro-organisms

EU Product safety

Some EN standards are also divided into parts. EN 71: Safety of toys, for example, has the following subparts:

  • EN 71-1: Mechanical and physical properties
  • EN 71-2: Flammability
  • EN 71-3: Specification for migration of certain elements
  • EN 71-4: Experimental sets for chemistry and related activities
  • EN 71-5: Chemical toys (sets) other than experimental sets
  • EN 71-6: Graphical symbols for age warning labelling
  • EN 71-7: Finger paints
  • EN 71-8: Swings, slides and similar activity toys for indoor and outdoor family domestic use
  • EN 71-9: Organic chemical compounds – Requirement
  • EN 71-10: Organic chemical compounds – Sample preparation and extraction
  • EN 71-11: Organic chemical compounds – Methods of analysis
  • EN 71-12: N-Nitrosamines and N-Nitrosatable Substances
  • EN 71-13: Olfactory board games, cosmetic kits and gustative games

Keep in mind that more than one EN standard may apply to the same product.

But what if you are importing a completely new product, for which no product standards yet exist?

Well, that doesn’t mean that you can sit back.

The very basis for product safety is that the products you place on the market, is safe. If there are no applicable standards to your product, you must still make a risk assessment, based on foreseeable usage by customers.

No terms of service or warning labels can remove your responsibility, if you place products on the market that harm your customers, or damage their property.

There is even a directive for all such products, called the General Product Safety Directive (GPSD):

 The GPSD applies in the absence of other EU legislation, national standards, Commission recommendations or codes of practice relating to the safety of products. It also complements sector specific legislation.

Specific rules exist for the safety of toys, electrical and electronic goods, cosmetics, chemicals and other specific product groups. The GPSD does not cover pharmaceuticals, medical devices or food, which fall under separate legislation.

Source: A safe product only policy (GPSD)

Substance Restrictions: REACH, RoHS, EN 71 and more

The fertility rate is decreasing in virtually all developed countries, and some believe that chemicals in consumer products and food packaging is to blame – at least partly.

It’s therefore no surprise that the European Union has implemented the strictest set of regulations in the world, for restriction of chemicals, heavy metals and other pollutants in consumer products and food packaging.

Below follows an overview:

Regulation Applicable to Description
REACH All Products REACH restricts chemicals (i.e., phthalates) and heavy metals in all consumer products. As such, it applies to everything from textiles and product packaging to watches and jewelry.
RoHS Electronics RoHS restricts cadmium, lead, mercury and other heavy metals in electronic components, PCBs, casing and solder.
EN 71 Toys / Children’s Products EN 71 restricts chemicals and heavy metals in toys and other children’s products.

Keep in mind that these regulations ‘overlap’ to some degree, in the sense that they restrict the same chemicals and heavy metals.

However, you should still ensure that you have tested your product for compliance with all applicable chemical, heavy metals and other substance regulations.

Document Requirements: Declaration of Conformity and CE Technical Files

In addition to ensuring compliance with all applicable product standards and substance regulations, importers must also create a set of documentation.

As explained in the table below, the document requirements vary depending on the product category:

Documents Applicable to Description
Technical file CE Mark Products within the scope of CE marking (i.e., electronics, toys, watches, sunglasses and more) must come with a technical file.

A technical file shall, at a minimum, include the following documents:

a. Declaration of Conformity
b. Bill of Materials
c. Design drawings
d. Manual
e. Label copies
f. List of standards
g. Risk assessment
h. Test reports

Declaration of Conformity (DoC) Food Contact Materials When importing kitchen appliances and other food contact materials, you must issue a DoC.
Test Reports All Products While lab testing is not mandatory for most products, the authorities may still require test reports to verify that your products are compliant.

So, who issues these documents? For the most part, the documents are issued by the importer.

It can be as simple as just writing a draft on your computer, print and sign it.

However, if you are importing private label products, you may need to obtain some documents from the supplier.

Such documents include design drawings and bill of materials.

Obtain these documents before placing an order, as some suppliers are reluctant to share ‘their IP’ once they’ve received the money.

Test reports, on the other hand, cannot be obtained from the supplier – as they can only be produced by accredited laboratories.

 Are you looking for compliance document samples?

We include a set of compliance document samples, label files and compliance checklists – as part of our Starter Package.

Click here to find out more

What do I need to do with these documents?

Many importers assume that they have to register the documents with the local authorities, or receive some sort of permit or approval.

That is, for most products, not a requirement.

Instead, the importer is required to maintain copies of the documents for a minimum of 10 years.

But you may need the documents long before that. The customs authorities are increasingly strict when it comes to ‘risk products’, including electronics and toys.

If you cannot provide the documentation upon arrival, the customs have the right to seize and destroy your products – with you paying for it.

But the customs is not everything you should be worried about. Assume that the customs don’t do a spot check on your shipment – you may still be required to provide documentation, several months or even years, after you’ve started selling your products.

If you don’t have the required documents, even if your product is technically compliant, they are subject to a recall, and you will be fined immediately.

As said, a product can be correctly labeled and pass every single lab test, and still be non-compliant due to a lack of compliance documentation.

That being said, creating the documents is relatively simple, and may only cost you a piece of paper and some printer ink.

Labeling Requirements: CE Marking, WEEE Symbols and more

You’ve probably seen them before. European Union compliance marks can be found on everything from bicycle helmets and power banks, to wristwatches and sunglasses:

Label Applicable to Description
CE Mark Various The CE mark is mandatory for many types of products. However, products that are not within the scope of CE marking must not carry it. CE marking products must also have a technical file, as explained in this article.
WEEE Electronics WEEE symbols relate to recycling requirements for electronics. Electronic products, and packaging, must be WEEE labeled.
Textiles Labels Textiles Clothing and other textiles products must carry a label, listing fiber composition and care instructions.

As an Importer, it’s your responsibility to create all label files, and submit them to your manufacturer.

In addition, you must also provide the following information:

  • Position
  • Dimensions
  • Color
  • Font files

Labeling requirements also apply packaging and user instructions.

Are you looking for product and packaging label samples?

We include a set of compliance document samples, label files and compliance checklists – as part of our Starter Package.

Click here to find out more

Laboratory Testing Requirements

Lab testing is the only way to verify that a product is compliant. Lab testing normally corresponds to a specific safety standard or other regulations.

As such, you can order ‘REACH SVHC testing’ or ‘EN 71 testing’, to verify that your imported products are compliant.

You will also receive a test report, that you can present to customs or other authorities, retailers and customers.

Further, Amazon also requires sellers to provide verifiable test reports for many product categories.

Yet, lab testing is not required by law for most products imported to the European Union. Instead, it’s up to the importer to decide whether or not if lab testing is necessary.

Even if compliance testing is not required by law for your product, there are two strong reasons for why you should get your product lab tested:

1. A lab test is the only way to ‘be sure’ that the product is actually compliant

2. As mentioned, the authorities have the right to request test reports, even in the cases when lab testing is not a legal requirement. Further, Amazon.com and other marketplaces set their own requirements, and have the right to deny or suspend any seller that fail to comply.

You can submit samples to a lab based in China or Hong Kong S.A.R, as long as it’s accredited by the authorities in your target market.

However, all major European and American testing companies have regional offices and testing facilities in China, and elsewhere in Asia.

“What can happen if I fail to comply with European product regulations?”

As an importer, you have the role of a manufacturer. As such, it’s your responsibility to ensure the products are compliant with all applicable regulations – be it safety standards, labeling requirements or documentation.

Failure to comply with one part, results in your product being non-compliant, and therefore subject to a forced recall, fines – or worse.

If anything, the European Union is getting stricter, as more people are becoming aware of the large number of unsafe products being imported from outside of the EU.

We get regular reports from business owners, with products stuck in the customs, or those who get ‘shut down’ at other stages.

A few cases follow below:

a. Watch product sample held by the German customs, for failing to produce a technical file

b. Undisclosed electronic items held in the United Kingdom, for failing to provide a Declaration of Conformity, manual, labels and test reports.

c. Toy wholesaler in Sweden, forced to recall all sold products, due to non-compliance with EN 71

In the latter case, the importer relied on their Chinese suppliers to provide the required documentation. For obvious reasons, they disappeared as soon as the importer requested support.

While many manufacturers in Asia may have an elementary understanding of European Union product regulations, it rarely extends beyond the most basic labeling requirements – or the need for lab testing.

Never rely on your supplier to confirm applicable EN standards, labeling requirements, document requirements or lab testing requirements.

You should not even let your supplier book a lab test.

In the end, you are legally responsible and they are not. Promises are cheap when you risk economic ruin, and not them.

It’s up to you to confirm all applicable regulations and then make sure that the correct procedure is followed.

Then again, when it comes to most products, ensuring compliance is not that complicated. The hard part is to find out which regulations apply to a certain product, and then how to practically make a product compliant.

“How do I find out which regulations apply to my product?”

We know how hard it can be to get a grip on product safety standards, labeling, documents and lab testing. To help startups get a grip on the process, and avoid crippling fines and forced product recalls – we created the Starter Package:

a. An overview of product safety standards in the United States, Europe, Australia & more

b. Mandatory document sample files

c. Product labeling template files

d. Checklists that guide you step-by-step through the entire compliance process

In addition, you can also book quality inspections, lab testing and shipping directly from the platform. Click here to learn more.

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    4 Responses to “Product Regulations in the European Union: A Beginner’s Guide”

    1. Iary August 16, 2017 at 4:09 pm #

      Dear China Importal!
      Thanks for your great job! It really helped our company in a lot of ways.
      I have a question regarding the situation occured: we are buying automotive electronics from a chinese manufacturer and this manufacturer has all the necessary EU market certificates (CE EMC, CE RED, RoHS, E Mark) for these products and gave us permission to use them. But inside all of these documents there is no information about our company and our products model names – only manufacturer`s company and model names. Can we use these certificates, test-reports and technical files together with the informational letter from the manufacturer (with a CEO stamp and signature) where the company informs that it cooperates wuth us and that their models are fully identical to our models? Or should we make again the same test-reports and certificates for the same products under different names?
      Thanks in advance for the answer!

      • ChinaImportal August 20, 2017 at 12:04 pm #

        Hi Lary,

        Great question. You can ONLY use supplier issued documents if the product is sold under their brand name. If the product is an OEM design, or even with your brand – you must issue all documents.

        Further, keep in mind that a DoC is not enough. You need a full technical file, and it’s very, very, rare that suppliers can provide this

    2. Jack Zhou August 29, 2017 at 3:04 pm #

      Great article Fredrik! I used to have taken two weeks to learn the regulations of the different industry. I assume you have spent a lot of time too :)

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