Requirements of Amazon Europe for CE marking of products

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Amazon requires that all products fully comply with national product regulations. In the EU, this means that quite a large range of products must be CE marked.

In this article, we will analyze what you need to know about Amazon CE marking requirements, document verification for compliance, common mistakes, and answer the most common questions about CE marking. We will also tell you why the July 16, 2021 is important date and what processes must be completed by that date so that you can continue to sell products in the EU.  

We begin traditionally with definitions.

What is CE marking?

CE marking is an indicator of product compliance with EU legislation, which allows the free movement of products on the European market.

What does the CE marking mean?

If the product is CE marked, it means that the manufacturer has confirmed compliance with the basic health and safety requirements specified in the applicable European directives and regulations.

By marking your product in this way, the manufacturer takes full responsibility for compliance with all European requirements for health, safety, performance and environmental protection.

The CE marking is found on many products that are sold in the European Economic Area (the EEA includes all 28 EU countries as well as Iceland, Liechtenstein and Norway).

The letters CE stand for Conformité Européenne, which means European conformity in French.

The appearance of the CE marking. From this link you can download files for marking your product or packaging. Available formats (png, gif, jpg, ai and eps)

Is CE marking required?

The CE marking is mandatory for products covered by one of the 25 CE directives or regulations. If the product is not covered by one of these Directives or Regulations, placing the CE logo is prohibited

Pay attention, more than one Directive or Regulation may often apply to a product. 

In addition: the CE marking does not mean that the product has been approved as safe for use within the EU. Also, this marking in no way indicates the origin of the product (a product with a CE marking could have been produced either within the EU or in any other country). 

To determine whether a Directive or Regulation applies to your product, read the scope and definitions of the Directive. Also check the exemptions not covered by the directive to see if your product is excluded.

Which categories of products are subject to CE marking?

СЕ маркировка наносится только на продукцию, которая попадает под действие определенных Директив ЕС (их более 20). В таблицу ниже мы свели список Директив, а также категории товаров, к которым они относятся.

EU DIRECTIVE OR REGULATIONCATEGORY OF GOODS OR SERVICES
Directive 2006/42/ECMachine equipment
Directive 2000/14/ECNoise equipment for outdoor use
Directive 2009/125/ECCable car laying
Directive 2009/125/ECEnergy products
Directive 2009/142/ECGas appliances
Directive 2009/48/ECSafety of toys
Directive 2011/65/EULimiting the use of certain hazardous substances in electrical equipment 
Directive 2013/29/ECPyrotechnic products
Directive 92/42/EECWater heating boilers
Directive 2014/28/ECExplosives for civilian use
Directive 2014/29/ECPressure receptacles
Directive 2014/30/ECElectromagnetic compatibility
Directive 2014/31/EUWeighing equipment
Directive 2014/32/EUMeasuring devices 
Directive 2014/33/ECElevators and elevator equipment
Directive 2014/34/EUEquipment and protective systems for use in potentially explosive atmospheres
Directive 2014/35/EULow Voltage Equipment (known as Low Voltage Directive)
Directive 2014/53/ECRadio equipment
Directive 90/385/EECActive medical implantable devices
Directive 2013/53/ECPleasure crafts
Directive 2014/68/ECPressure equipment
Directive 98/79/ECMedical devices for in vitro diagnostics
Regulation (EU) No. 305/2011Construction Products
Regulation (EU) 2017/745Medical devices
Regulation (EU) 2016/425Personal protective equipment

Elevators, pleasure crafts, implants… What does that have to do with me?

You have glanced through the list of directives and product categories and you might reasonably have such a question. To give you an idea of how serious it is, here are some explanations.

Let’s start with the most obvious things, Directive 2014/35/EU (Low Voltage Directive) concerning low voltage electrical equipment. By the way, it used to have the number 2006/95/EC. Keep in mind that directives are often updated, supplemented and merged, and this in turn leads to a change in their numbering. Therefore, if you search for information on this or that Directive, take this fact into account. 

So, Directive 2014/35/EU (link to its text) applies to any electrical equipment designed for operation at nominal voltages of 50 to 1000V for alternating current and 75 to 1500V for direct current.

This means that any toaster, electric kettle or curling iron sold in the EU must be CE marked. You can do a little experiment and check your Tefal or Philips home appliances, you will find the CE mark on all appliances.

We promise, it is going to get even more interesting.

The single pint glass should also be marked with the CE mark. Surprisingly, it is a measuring instrument.

In the photo above you see the one-pint glass that is for sale on UK Amazon. The quality of the photo needs some work by the seller, but it shows the main thing – the CE marking. And there is no mistake, it is really needed there, because this glass falls under Directive 2014/32/EU – measuring equipment. 

The fact is that the single-pint glass is designed to “hold” either a British (“imperial”) pint, which is equal to 20 imperial fluid ounces (568 ml), or an American pint – that is, 16 US fluid ounces (473 ml), which means that the glass is a measuring device.

The photo below shows sunglasses with CE marking on the temple. Can you guess which Directive they fall under, since the Eyeglasses Directive is not on the list for mandatory marking? 

If you haven not guessed, we will tell you – Regulation (EU) 2016/425 on Personal Protective Equipment. Sunglasses protect your eyes from sunlight (UV radiation, to be precise) and are therefore considered personal protective equipment.

Sunglasses protect the eyes from UV radiation, and therefore fall within the scope of Regulation (EU) 2016/425 on personal protective equipment and must be CE marked

We recommend to pay special attention to the Directive 2009/48/EC (you can find the text of the Directive here), which regulates the safety standards for the manufacture of toys (mainly for children under 14 years). 

This Directive limits the amount of certain chemicals that can be contained in materials used for toys. For example, CMR substances (carcinogenic, mutagenic or toxic to reproduction) and lead are no longer allowed in accessible parts of toys. Acceptable limit values have been introduced for such substances, such as nickel.

It is more convenient to work with this Directive from the opposite direction, i.e. to look at the exceptions (in Appendix 1), i.e. the list of toys, which it does not apply. For example, the Directive does not apply:

  • Products for collectors from +14 years old (e.g., historical replicas of toys, folk or decorative dolls);
  • Sports equipment designed for children weighing over 20 kg;
  • Bicycles with a saddle height of 435+mm;
  • Puzzles with more than 500 pieces;
  • Fireworks;
  • Game consoles;
  • Pacifiers (although they are designed for children under 14 years of age).

Another interesting point is that writing materials in the form of toys (pencil sharpeners or erasers in the form of toys, pens in the form of animals, bubble pens) fall within the scope of this Directive.

Even crayons, colored pencils, wax crayons, toy stamps and finger paints (if they are not used for artistic purposes and are not sold in stores specializing in equipment for artists) are covered by Directive 2009/48/EC on toy safety.

A few more examples and we will move on.

It is quite common to find a situation where one product may fall under several Directives. For example, if you sell electronics in Europe, in addition to the Directive 2014/35/EU (Low Voltage Directive) described above, you should pay attention to Directive 2011/65/EU, often referred to as RoHS (Restriction of Hazardous Substances). It regulates the use of hazardous substances (lead, mercury, cadmium, hexavalent chromium, biphenyls, etc.) in electrical equipment.

The RoHS Directive applies to:

  • large household appliances;
  • small household appliances;
  • IT and telecommunications equipment;
  • household equipment;
  • domestic equipment;
  • electrical and electronic tools;
  • toys, leisure and sports equipment (meaning electrical goods);
  • medical equipment;
  • monitoring and control tools;
  • automatic dispensers;
  • other electrical goods not included in any of the above categories.

The Marshall portable speaker is subject to several EU Directives..

And if your electrical device also contains Bluetooth, it is subject to another Directive – 2014/53/EU, which is called RED (Radio Equipment Directive). Among other things, it applies to:

  • Bluetooth speakers
  • Bluetooth headphones
  • RFID devices
  • Smartphones
  • Smart TV

IMPORTANT! The exact answer as to whether the product falls under the requirements of the relevant EU Directive can be given by the provider or certification agent after evaluation.

As you can see, it is not always clear from the name of the Directive what kind of safety standards it covers. Another example: the seemingly unremarkable Machinery Directive 2006/42/EC covers 3D printers.

Our recommendation: study thoroughly the scope of the Directive. Their full text can be found on European sites, for example, in the online library of European legislation EUR-Lex. It is not superfluous to consult a specialized specialist from organizations that deal with the certification of goods, but we will talk about this later.

Which countries accept the CE mark?

The CE marking is essentially a set of rules for certain products that are sold in the European Economic Area (EEA). The EEA includes all 27 EU countries as well as Iceland, Liechtenstein and Norway.

The countries in which CE-marked products can be sold are shown in the table. And just below it is an explanation of why there are more than 27 countries.

AUSTRIABELGIUMBULGARIACROATIA
Denmark
CyprusCzech RepublicEstonia
FinlandFranceGermanyGreece
HungaryIrelandItalyLatvia
LithuaniaLuxembourgMaltaPoland
Romania
NetherlandsSlovakiaSlovenia
SpainPortugalSwedenIceland
NorwayLiechtensteinTurkeySwitzerland

The EEA includes the EU countries as well as Iceland, Liechtenstein and Norway. This allows them to be part of the EU single market.

All of these countries operate as a single market in which the free movement of goods, capital, services and people between member countries is allowed.

We need to explain how Turkey and Switzerland ended up on this list.

Switzerland is neither a member of the EU nor the EEA, but is part of the single market. This means that CE products can also be sold in Switzerland.

Turkey, for its part, is neither a member of the EU nor part of the EEA. But since Turkey has fully complied with most European directives on CE marking, this means that CE-marked products can also be freely sold in Turkey.

European Economic Area countries. In addition to these countries, products with a CE marking can be sold in Switzerland and Turkey.

Why the ce marking is especially important in 2022

And here we are getting to the most important part: why the issue of marking is especially important in 2022.

From July 16, 2021, the new Regulation 2019/1020/EU (Market surveillance and compliance of products) will come into force. After this date, CE marked products will not be sold in Europe without an EU Responsible Person.

EU Responsible Person can be:

  • Manufacturer or brand, if registered in the EU.
  • Importer registered in the EU.
  • Authorized representative established in the EU, who is appointed in writing as the responsible person of the manufacturer or brand.
  • EU-established fulfillment service provider, such as Amazon.

And now the most important thing: this person must be registered in the European Union.

By July 16, 2021, interested companies must ensure that their CE-marked products still comply with quality and safety standards and that they include the contact details of the responsible person. This marking can be applied to the product, its packaging or an accompanying document.

After this period, it will be illegal to sell products with a CE marking in the EU without a designated EU Responsible Person established in the area and without the appropriate label.

What should the EU Responsible Person do?

The EU Responsible Person must do the following:

  • Collect the EC Declaration of Conformity of the product (or the Declaration of Performance) and make sure that additional documents demonstrating the product’s conformity with EC regulations can be provided by the manufacturer or brand owner upon request in language that the authorities can understand.
  • Report to the authorities any risk related to the product.
  • Cooperate with market surveillance authorities, including ensuring that the manufacturer or brand owner takes the necessary corrective action to correct any product non-compliance.

But do not be scared, Amazon offers itself as a responsible person to its sellers and is ready to act on their behalf in the EU markets.

CE marking and Amazon

Amazon requires that all products sold by third-party sellers meet product safety standards and marking requirements in each relevant market. Thus, products that require CE marking in the European Union must be CE marked in order to be sold on Amazon’s European marketplaces.

The CE marking is mandatory in all EU countries. Thus, CE marking is required when certain products are sold on Amazon’s European sites:

  • www.amazon.de
  • www.amazon.it
  • www.amazon.fr
  • www.amazon.se
  • www.amazon.es
  • www.amazon.nl
  • www.amazon.pl
  • www.amazon.com.tr

Because of Brexit, there is an interesting situation with the UK. The CE marking, at least, is still required on Amazon.co.uk, but this may change in the coming years.

Just applying a CE sign on your product is not enough

Will Amazon ask sellers who deal in products covered by one of the Directives? The answer is yes, definitely. 

CE conformity is much more than just putting a CE mark on a product. In short, you need to obtain or issue the following documents to confirm the CE mark (you may not need the whole list):

  • Laboratory test reports
  • Declaration of Conformity (DoC)
  • Declaration of Performance (DoP)
  • Technical file
  • Certificates
  • User manual

Where do I start in the case of Amazon?

In this article, we provide some basic information to make it easier to understand what CE marking is, who needs it, etc. Next, you will need to “dive into” the topic yourself and study everything in detail.

We recommend you to start with these links:

  • On this page you will learn general information on CE marking;
  • In this section, the categories of goods that may be subject to CE marking requirements are described in more detail;
  • Another page on CE marking, where the concept of the EU Responsible Person is described in detail (you have to log in to SellerCentral to view the page);
  • On this page (continuously updated) you will find a list of provider companies certified by Amazon that can act as a Responsible Person (you need to be logged in to SellerCentral to view the page);

Regarding the last link: note the disclaimer from Amazon itself: “These services are not advertised on the labs page, but if you contact one of the following companies through their compliance provider network page, they will explain the details of how to use their services.

There is one point that is important to understand.

CE marking is in principle a self-certification process. Only some products require the product to be tested and certified by an authorized body.

Что это значит?

What does this mean?

It means you do not need a notified body for most products. In these cases, you can still outsource part of the CE marking process and work with a CE expert (you can get companies from the list provided by Amazon), have only tests done by a testing lab (from the same list), or do everything yourself, of course when you have the right equipment.

So, to be clear, you can interact with the following types of companies in the process of marking your products for the EU:

Company TypeCompany Role
Authorized bodyRequired only when required by certain Directives and for certain product groups.
Testing laboratoryIt can help you perform tests such as flammability testing (for toys), EMC testing, or low voltage testing.
CE ConsultantsIt can walk you through the entire CE process, contact suppliers, determine if third party (Authorized Body) certification is required, conduct a risk analysis (if necessary), etc.
Technical Documentation AgencyIt supports you in creating operating and safety manuals.

CE marking and Amazon: the technical side

If you sell on European Amazon sites, we recommend that you keep a close eye on your account. Some listings may start to get flagged as such and need to be entered the data of an EU Responsible Person.

If you see the corresponding notification in your account about the responsible person, it is worth checking for which products such a request was received. The listings will light up as under consideration. 

For them, you will need to enter the name of the company and its official address.

As we have already pointed out, Amazon can also be the responsible person, charging for its services. The data can be obtained upon request from support.

Important point: this solution is only suitable if your sales in the EU are focused exclusively on Amazon, because the marketplace does not provide documentation (which you can use on other sites) and consultation, unlike other firms.

If your production is located within the Eurozone, you can specify your data on the form (plus the mandatory CE marking).

If you are importing goods from outside the EU – you definitely need a responsible person who is registered within the EU.

Common mistakes in CE marking

There is a statement on the market that you do not need to do CE marking if you have a CE certificate from your manufacturer.

This is incorrect!

The CE certificate that is often submitted by the manufacturer is a test report, such as an EMC or LVD report. This is just one of the required technical documents as part of the conformity assessment process (step 4), which must be included in the technical file (step 5). We will discuss the necessary steps in the next paragraph.

The second common mistake is to mistake the Declaration of Conformity for a CE Certificate. This is also incorrect. Keep in mind that the Declaration of Conformity must always be signed by the person who places the product on the European market.

CE marking algorithm

The last thing we will discuss today is the sequence of necessary steps for CE marking your products and preparing them for sale in the EU after July 16, 2021.

Step 1. Determine the applicable directives

As we wrote above, several Directives may be applicable to one product. All of them are harmonized at European Union (EU) level and establish the basic requirements (e.g. for safety) that your product must comply with.

Step 2. Check the basic requirements for your product

Download and review each of the applicable Directives. Each outlines the legal requirements of the EU to ensure that your product meets the requirements. You must ensure that your product meets these requirements.

Step 3. Check whether your product requires a third-party conformity assessment

Some Directives require an authorized third party, known as a notified body, to test and certify your product to ensure compliance. This conformity assessment procedure is not mandatory for all products.

If you find that you need a notified body, start with the list provided on Amazon.

It is important to note here that more than 90% of the time, CE marking is a self-certification process. Here is one example:

Low Voltage Directive (2014/35/EU)

The Low Voltage Directive explains in the conformity assessment section that this procedure can be carried out by the manufacturer and thus CE marking is a self-certification process:

A manufacturer with detailed knowledge of the design and production process is best suited to perform a conformity assessment procedure. Conformity assessment should therefore remain the sole responsibility of the manufacturer. There is no conformity assessment procedure in this Directive which requires the intervention of a notified body.

Step 4. Test the product and check its compliance

Unless you need to involve a notified body, you must rely on your own means to verify your product’s conformity. The directives specify which conformity assessment procedures (also known as modules) you can carry out. 

This is where you may need the results of testing products for compliance with CE standards from your manufacturer.

Step 5. Create and maintain technical documentation

All CE marking directives require manufacturers to create and provide technical documentation (i.e., a technical file) that shows that the product meets the requirements of the applicable Directive.

The type of information you must keep and the period for which you must keep it depend on the Directives and regulations (very often a period of 10 years).

Examples of what may need to be included in the technical documentation:

  • general product description
  • detailed drawings
  • list of applicable standards
  • copy of the risk assessment
  • copies of technical reports
  • instructions
  • manufacturer’s declaration, etc.

Step 6. Signing the EU Declaration of Conformity and affixing the CE marking

The final steps in the CE marking process include application of the mark on your product and signing the Declaration of Conformity. 

The declaration confirms that the manufacturer is fully responsible for the conformity of its products with all applicable CE marking directives.

Amazon wants to make sure that your products are properly labeled. Therefore, Amazon sometimes requires photocopies of the product and packaging to make sure that the product actually has the CE marking.

Conclusions

If you know entrepreneurs that sell categories of goods that fall under the above or who have already received a notification from Amazon about the need to designate a responsible person, please share a link to this material with them. 

And, of course, the CE marking issue should not be delayed. July 16, 2021 is pretty close, and Amazon is planning to start inspecting those responsible soon.

In addition, we can recommend reading the so-called “Blue Guide“, which is a comprehensive guide to the implementation of EU product regulations.

Do not forget to subscribe to our blog news and write a short comment if the article was useful for you.

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