The EU market surveillance regulation came into force in the EU on July 16 2021. It amends 18 CE marking directives in order to:
Most of the regulation is concerned with arrangements for market surveillance and border authorities such as such as consumer protection, health and safety, environmental protection and customs authorities.
Article 4 gives requirements for suppliers of products, called ‘economic operators.’ The main new requirement is for every regulated product to have a responsible economic operator in the EU before it is placed on the market.
The main type of supply chain affected is online sales from non-EU websites, which have not previously had an economic operator in the EU.
The arrival of the regulation closely follows Britain leaving the EU single market in January 2021, making the situation for British products more complicated.
Appointing an Authorised Representative with expertise in product safety is the simplest way to get a responsible economic operator without disrupting the existing supply chain.
Which part of the EU Regulation on Market Surveillance says what suppliers have to do?
Article 4 gives the requirements for ‘economic operators’ (i.e. Manufacturers, authorised representatives, importers, distributors and fulfilment services.) The rest of the regulation gives requirements for market surveillance and customs authorities to help them cooperate better and be more effective.
What do suppliers of products have to do?
All products covered by the 18 directives and regulations and placed on the EU market must have an economic operator established in the EU, referred to as the ‘responsible economic operator’. They must liaise with the manufacturer to get product safety information when the market surveillance authorities request it and cooperate with action on non-compliant products.
When do suppliers have to be ready?
Article 4 of the EU Regulation on Market Surveillance, on the tasks of economic operators applies from 16 July 2021.
Does the Regulation (EU) 2019/1020 apply in the UK?
With a start date of 16 July 2021, it was not in operation when Great Britain left the single market in December 2020 and therefore the EU Withdrawal Act did not retain it as UK domestic law in Great Britain (England, Scotland and Wales).
It does apply in Northern Ireland to allow continued single market membership under the NI protocol of the EU withdrawal agreement. NI legislation has been amended to incorporate the EU regulation.
Which products require a responsible economic operator?
A responsible economic operator is required for products:
Which Directives and Regulations are listed?
|Construction Products Regulation
|Personal Protective Equipment Regulation
|Gas Appliances Regulation
|Outdoors Equipment Noise Directive
|Toy Safety Directive
|Ecodesign for Energy-Related Products Directive
|Restriction of Hazardous Substances (RoHS) Directive
|Pyrotechnic Articles Directive
|Recreational Craft and Personal Watercraft Directive
|Simple Pressure Vessels Directive
|Electromagnetic Compatibility Directive
|Non-Automatic Weighing Instruments Directive
|Measuring Instruments Directive
|Low Voltage Directive
|Radio Equipment Directive
What about non-CE-marked ‘general’ products?
The regulation only covers products in the scope of one or more of harmonisation laws requiring the CE marking. The General Product Safety Directive applies the same principles to other consumer products requiring economic operators in the EU (if there are any) to represent them but it contains much less detail.
Which countries are in the EU single market?
What does “placed on the market” mean?
A product is placed on the market when it is, supplied for distribution, consumption or use on the EU single market for the first time in the course of a commercial activity. It includes products supplied free of charge.
‘Product’ means each individual product, not a model or type of product. Consequently, even if products of a certain model or type have been supplied before 16 July 2021, individual units of the same model or type which are placed on the market from 16 July 2021 onwards must comply with the new requirements.
When is a product on an overseas website considered to be “placed on the market”
Offering a product for sale online is considered to be “placed on the EU market” if the website is targeted at end users in the EU or EEA. This depends on factors such as:
If a website does not target EU consumers with dispatch to the EU, payment in EU currencies or pages in EU-only languages, then the product is considered to be placed on the market overseas Then it is not “placed on the EU market” and not subject to Regulation EU 2019/1020.
Who can be the responsible economic operator?
The responsible economic operator can be one of four types:
The flow chart from the EU Commission’s guide explains who is the Responsible economic operator in different supply chains:
Who is the responsible economic operator in a conventional supply chain with an importer and distributor?
The importer is the responsible economic operator unless the manufacturer has appointed an authorised representative in the EU / UK.
Who is the responsible economic operator when a fulfilment service provider in the EU handles the product?
The fulfilment service provider is the responsible economic operator, unless the manufacturer has appointed an authorised representative in the EU, in which case the AR will be the responsible economic operator instead.
Who is the responsible economic operator when the product is shipped from outside the EU directly to the end-user?
An authorised representative in the EU is the responsible economic operator. If the manufacturer has not appointed such authorised representative, the product cannot be offered for sale to EU end-users.
Is an online marketplace an economic operator?
Online marketplaces operate in a variety of ways:
Some online marketplaces offer products in all these ways. The service they offer for each listing decides which type of economic operator they and the seller are and who is responsible for meeting Regulation EU 2019/1020.
What information on the responsible economic operator must be provided with the product?
The name and postal address, have to be indicated on or with the product. The name can be a registered trade name or registered trade mark instead of the registered company name. A postal address is normally made up of a street/post office box, building number, postcode and town.
How can an authorised rep’s contact details be indicated?
It must be indicated on:
How can manufacturers’ and importers’ contact details be indicated?
CE legislation is stricter than EU 2019/1020 and requires details on the product itself. If it is not reasonably practicable then primary packaging or an accompanying document can be used.
Product marking is not reasonably practicable for products that:
Which Authorities require the contact details to be marked?
The responsible economic operator’s contact details have to be present when the product is declared at customs. Customs officials may not release products for free circulation in the EU if they are not found.
CE marking legislation also requires the manufacturer’s and importer’s contact details to be indicated to allow market surveillance officers (such as consumer protection and health and safety officers) to facilitate checks throughout the supply chain.
Can a phone number, email address or website be indicated instead?
No. These are not an adequate substitute for a name and postal address. They are encouraged as additional means of contact.
What if there are multiple names and addresses?
It should be made clear which of them is the responsible economic operator, for example by indicating ‘authorised representative,’ ‘represented by’ or ‘Responsible person Article 4 of Regulation (EU) 2019/1020’.
Where the economic operators’ roles are not specified, the authorities will determine them themselves. Each economic operator should be able to prove its role.
Do I need to translate the titles ‘manufactured by’, ‘represented by’ etc.?
No. The English terms ‘manufactured by’, ‘imported by’, ‘represented by’ or ‘fulfilled by’; are considered easily understandable throughout the EU
What are the tasks when they start representing a new product?
When they start representing a product range or when a new product is added, they must:
What are the tasks when a product presents a risk?
If they discover or receive a report of products that present a risk, they must:
What else can a market surveillance authority ask them to do?
What if the authorised representative or other responsible economic operator cannot complete their tasks because the manufacturer won’t cooperate?
If the manufacturer does not respond to a request and to a reminder of their obligations, they should cease being the authorised representative or other responsible economic operator. This would mean, in the case of:
What are the penalties if the authorised representative or other responsible economic operator fails to fulfil its tasks?
Member states set effective, proportionate and dissuasive penalties for failing to fulfil the tasks in Regulation (EU) 2019/1020.
Can the authorised representative or other responsible economic operator bear lability for injury caused by a dangerous product they represent?
The manufacturer remains responsible for the compliance of the product and retains any legal obligations it has as regards liability for defective products. Regulation (EU) 2019/1020 does not impose additional legal obligations on the authorised representative or other responsible economic operator.
They would bear some liability for injury caused it they became aware of a dangerous product and failed to report it or take action.
Where can I find out more about regulation EU 2019/1020?
EU guidance document (in different languages) comprehensive guidance on EU harmonisation legislation: Blue guide