Revision of the E-commerce directive/Digital services act
The position of the Nordic Commerce Sector
*The E-commerce directive/DSA covers all kinds of digital platforms. This paper only focuses on online
marketplaces that facilitate the sale of tangible goods.
Online marketplaces have given retailers easier access to consumers and benefit
consumers through more choices, lower prices and convenience.
At the same time, the online marketplaces have opened the European market to sellers
from 3rd countries whose products many times do not comply with EU rules on product
safety, consumer rights, etc.
European surveillance authorities do not have jurisdiction to hold companies outside the
The Nordic Commerce Sector therefore wants de facto responsibility and liability for
the online marketplaces when actively facilitating the sale of goods to a consumer on the
European market. Their degree of responsibility and liability must – as any other
economic offline as online operator - be assessed according to the actual role they play in
the trade chain and marketing of the product.
The online marketplaces have transformed the retail sector and challenged the conventional structure
of trade chains. Through modern business models they have changed e-commerce and the commerce
market in general and affected the consumers way of shopping.
Online marketplaces have become very popular among consumers. In the Nordic countries, online
marketplaces are on the top-10 list of consumers preferred online shops. In the US, the UK, Austria
and Germany, Amazon has around 50 percent of the online market of sale of tangible goods. In many
ways platforms are becoming the market when it comes to e-commerce.
This development has created new opportunities for retailers and brand-owners by creating value
adding and more efficient ways of reaching consumers, and have at the same time increased
competition which has resulted in more choices, lower prices and convenience for consumers.
However, the legal framework has not kept pace and adjustments and clarifications are needed to
ensure a level playing field in the commerce sector.
The original version
of online marketplaces were intermediaries between the seller and the end-user
(typically the consumer). They were not active in the selling process themselves, but merely facilitating
the sale. These kind of online marketplaces do not typically own the products that are being sold on
their website, nor do they act
as sellers or owners of the products and the consumer are clearly aware
that they are entering into an agreement with a seller which is not the online marketplace. These
online marketplaces are merely connecting the sellers and buyers and provides merely the technical
assistance for this connection. They function as an online flee market.
Today the picture is something different and there is much more activity from the platforms. The
platforms take active roles during the selling process. The biggest and best-known online marketplaces
in the consumer goods business are Amazon, AliExpress, E-bay and Wish. Some of them serve both as
a retailer and/or manufactures or importers with own brands, or reselling products they contractually
own themselves, as well as an online marketplace where other operators can sell their goods to
Acting as an online marketplace in many cases, the platforms in many cases encourage and enables
the sales of goods from third country sellers, and they profit from the sales.
The services offered by the online marketplaces are as such not simply limited to providing third
country sellers the ability to list their products they wish to sell. Online marketplaces often go much
further, providing marketing, storage and dispatch of the products as well as the provision of payment
solutions, delivery services and take care of the returns and customer care and complaints.1
Indeed, in many cases the online marketplaces require the sellers to use the services that they offer,
such as their payment solutions, while charging a fee or commission for that privilege. Hence, this is
often something the seller cannot negotiate with the online marketplace.
Further, it is in many cases not clear to the consumer if the seller is the platform or a 3rd party seller.
In spite of this evolution; the above described online marketplaces often (claim to) act as passive
intermediaries between two independent parties - the seller and the buyer.
If categorized as passive intermediaries they are not liable, or have only very limited liability, for the
actions related to sale of the products they are mediating This follows from the horizontal liability
exceptions in the E-commerce directive article 14 and 15. However it also follows from this directive
and the jurisprudence that active online market places are not excepted from liability. Nevertheless,
all the online marketplaces mentioned above have in practice succeeded with promoting themselves
as passive intermediaries. We believe that it must be clarified in the DSA that the exemption does not
apply to active platforms. In this connection we refer to a legal note on the matter2 which is attached
to this paper.
The EU regulations for the sale and safety of tangible goods are based on the conventional trade
model with economic operators (importers) importing the goods to EU and other economic operators
resell the product through physical or online stores to consumers (distributors). The main idea of this
model is that there is an economic operator (a manufacturer, an importer in certain cases an
authorized person and a distributor) established in the single market who is responsible for the legal
obligations arising from selling products to EU consumers and which can be held liable if they do not
follow applicable rules or the product is not compliant. This includes responsibility and liability for
product safety, consumer protection, copyright etc.
1 See, for example, Fulfilment by Amazon
2 For further on the legal framework and liability excemptions in the e-commerce directive, please see annex
XX (note from Wiggin Lawfirm, Brussels).
Below we have inserted an Illustration of obligations concerning product safety of economic
operators in the trade sector (the example is taken from the explanatory guidance document to the
Toy Safety Directive3) For a line-up of obligations arising from Decision 768/20084 and obligations
arising from the General Product Safety Directive, please see annex 1. -
When goods are sold to European consumers via an online marketplace from a supplier or
manufacturer which is not established in the EU, a legal loophole occurs when the online
marketplaces claims to have none of the roles described above.
4Annex I: article R4: https://eur-lex.europa.eu/legal-
As a consequence, no responsible and liable operator is established in the EU and no one in the Single
Market, also excluding the platforms, has formally taken over the liability, cf. the table above.
It is nevertheless presupposed in the product safety legislation that no products should be placed on
the European Market without being compliant and having an economic operator to take responsibility
and liability for the safety of the product.
In these cases there are therefore no practical possibility to hold an EU operator liable (see, among
other things, the Swedish Retail and Wholesale Council's report on digital platforms and e-commerce
marketplaces from 20195).
Different actions have been taken by the previous Commission, but unfortunately neither of those
have achieved any substantial effects.
Even though the new Enforcement and compliance regulation6 which comes into force in 2021 will
allow authorities to control private purchases from from 3rd countries and oblige the 3rd country seller
to appoint as minimum an authorized person with a range of obligations relating to the
documentation of the safety of the product and corporation with the authorities, if there is no
importer in the EU connected to the product, the problem will not be solved in practice. Further this
Regulation only covers products covered by the sector-specific legislation.
According to the draft for guidelines to article 4 of the market surveillance regulation “there is no
specific obligation arising from article 4 on operators of online marketplaces when they are merely
providing information society services”
(p.5). The draft guidelines thus indicate that there are no
specific obligations arising from Article 4 on operators of online marketplaces when they are merely
providing information society services. However, it does not clarify when operators of online
marketplaces are active and therefore not merely providing information society services.
As mentioned, in practice online marketplaces do usually provide additional services, in particular
optimizing the presentation of the offers for sale in question or promoting those offers and are
therefore active and not exempted according to the e-commerce directive.
It would have been helpful if the guidelines from the Commission had clarified that usually, the online
marketplace places the product on the EU market by targeting end-users in the EU for products sold
by third-party sellers/manufacturers on their website. They do so by directing their marketing
activities, offering products in national languages, and by enabling payment in local currencies and
with EU payment methods. In those cases, the online marketplace would in practice have the same
function as an importer and should as such be the ‘responsible economic operator’ and have the
duties following from that role in the trade chain. However, this is not yet clarified in the drafted
guidelines or elsewhere and therefore we need this clarification in real legislation, as for example the
One could argue that there is no need to have a liability for the online marketplaces, since all the 3rd
country sellers after 2021 have to appoint as minimum an authorized person that has duties according
to article 4 of the market surveillance regulation. However, it also follows from the draft for guidelines
(p. 8) that “The responsible person does not have legal obligations vis-á-vis consumers or other end
users pursuant to the Regulation”
. This of course creates a unlevel playing field towards the economic
operators taking part of a conventional trade chains, where the importer and/or distributor has such
a liability and are subject to duties and tasks that go beyond the tasks applying to the authorized
Further, it must be expected that this new regime with a new responsible economic operator – an
authorized person - for the 3rd country sellers is an ineffective measure due to the fact that there are
billions of different sellers operating on the online marketplaces. As such it will in practice have little
or no effect on the amount of unsafe products arriving to EU consumers, since it is unrealistic to expect
market surveillance authorities to verify whether billions of EU-addresses are correct, nor will it be
possible to prosecute against sellers if the EU-addresses are fake or absent.
The sheer number of parcels means that it is impossible to check everything or even a small part of
the packets at customs. In late 2017 the number of parcels arriving only to Arlanda airport in
Stockholm was 150 000 per day. In Denmark more than 43.000 parcels arrive from China every day in
Finally, it is worth mentioning that this new Regulation does not even specify that online marketplaces
need to verify whether 3rd country sellers adhere to these rules and have in fact appointed an efficient
The lack of clarification in the interpretation of the current legislation7 and the lack of enforcement
means, in practical terms, that products sent directly to consumers from non-EU countries, products
bought through both EU and non-EU online marketplaces do not require the same level of compliance,
as if the products where bought through the conventional trade chain where an EU-importer buys the
products from a manufacturer (from a non-EU country) and resell it to European consumers. In the
latter case the first commercial actor in the EU typically the importer (or in some cases the distributor))
for example has the responsibility to check that the manufacturer has in fact compliance systems and
procedures in place to secure the safety of the products, further this importer in certain cases has to
carry out test of the samples they place on the market.. Further the EU-importers (and in some cases
the distributors) are in fact the liable operators also according to Council Directive 85/374/EEC of 25
July 1985 on the approximation of the laws, regulations and administrative provisions of the Member
States concerning liability for defective products.
It is not in any way clear in a European context how an online marketplace as described above would
be considered in terms of liability for defective products, if a product from an 3rd country seller is
defective. This also needs to be clarified and it would seem both damaging for the consumer safety
and the level playing field towards the mentioned conventional traders if the online marketplaces
where not to take on any liability for these products coming directly from e.g. China.
European consumers are often unaware of this situation and therefore gets exposed to products that
do not comply with chemical rules and safety standards given the fact that no economic operator in
7 For further on the legal framework and liability excemptions in the e-commerce directive, please see annex
XX (note from Wiggin Lawfirm, Brussels).
EU has an incentive to secure the safety of the product in accordance with EU legislation. A lot of
telling examples have showed up the last years. Just to mention some of them:
1) Astudy done by the Swedish National Electrical Safety Board where 10 out of 10 USB-chargers
sampled were deemed dangerous.8
2) Two studies carried out by the Danish Consumer Council which revealed illegal doses of
phthalates in 9 out of 29 toys9 - in some the threshold was exceeded 200 times. Another test
revealed toys with long strings and small pieces which were dangerous for children10.
3) In February 2020, six European consumer groups tested 250 electrical goods, toys, cosmetics
and other products bought from online marketplaces such as Amazon, AliExpress, eBay and
Wish. Two thirds of the tested products failed EU safety laws.11
4) A recent study by the Toy Industries of Europe (TIE
) on the availability of illegal and dangerous
toys on online marketplaces. 197 toys were bought from third-party sellers on four major
online marketplaces. TIE found that 188 toys did not comply with EU rules and more than half
the toys posed serious safety risks. These risks include choking, suffocation, strangulation,
drowning, burns and exposure to harmful chemicals.12
5) The Danish Chamber of Commerce have also recently made a large study of the behavior of
the platforms and online marketplaces and included assessments of the safety of 50 products
bought on the online marketplaces in the period May 23rd 2019 to November 4th 2019.
This study shows that:
a. 46 did not comply with EU Product Safety rules
b. 50 did not complied with consumer rights
c. 0 showed a match between the seller on the platform and the sender of the package
d. 0 contained an order form or an invoice
e. 42 products are warned about and/or recalled by national and/or EU authorities. We
have received no notification hereof from any of the 3 platforms.*
f. 38 identical products or products appearing identical to the recalled products are still
available on the platforms as of the 18th of February 2020.
g. 46 had a different value written on the package than the price paid.
h. 0 of the 16 VAT-guilty packages had paid the VAT due to an undervaluation of the
package of the total of 50 products, all bought on the platforms; Amazon, AliExpress
and Wish.com. The products have been purchased in the period from
The current EU legal framework also severely affects the competitiveness of European companies,
especially SMEs. A study by the Finnish Commerce Federation estimates that the average purchasing
price for a (on the surface) comparable product that does not comply with European product safety
legislation can be sold to consumers at a significantly lower price than products complying with the
legislation and still be profitable. This is not only due to the fact that the use of legal processes and
materials are more expensive but insomuch because it is very expensive to facilitate a good and sound
compliance system that makes sure that the sold products are legal and safe. This means that it is
11 See BEUC press release of 24 February 2020, available here.
12 TIE’s investigation is available on its website an
d also referred to here.
impossible for responsible European companies to compete with the price of the products sold
without complying with the EU-regulation on product safety.
Illustration of the price difference between compliant and non-compliant products in B-to-B
In June 2018 the European Commission signed a Product Safety Pledge13 with four online
marketplaces: Alibaba (for AliExpress), Amazon, eBay and Rakuten-France. These four online
marketplaces committed themselves to respond to notifications on dangerous products from Member
State authorities within 2 working days and take action on notices from consumers within 5 working
Even though it is positive that these four online marketplaces agree to respond to notifications, the
pledge does not solve the problem. Firstly, because it only covers four online marketplaces, secondly
because it is voluntary, but thirdly and most importantly because it still is a reactive and passive
obligation in its nature, i.e. it only affects the products that authorities and consumers have proven
are non-compliant and does not oblige the platforms to take any proactive measures to secure that
the unsafe products are not sold to EU consumers. These platforms have billions of products on their
online shelves that will never be subject to any compliance actions or assessed or sample test.
The efficiency of the Product Safety Pledge should therefore also be challenged . After the study by
the Danish Consumer Council in June 2019, which revealed toys with phthalates up to 200 times the
EU-threshold14 from Amazon, eBay and Wish, one could have thought that the online marketplaces
would take actions. Even though all three platforms promised the Danish Environmental Agency to
remove the toys from their website, the same toys with the same content of dangerous chemicals was
purchased by the Danish National Broadcaster DR in August and October15. Further it is obvious from
the study from The Danish Chamber of Commerce that this behavior is not unusual. In those cases,
the online marketplaces actually remove the unsafe products, the same products tend to pop-up on
the online shelves again, just sold from a different seller. Hence the system is inefficient and not
serving as a protection system.
According to the safety pledge the platforms are only obliged to act if authorities, consumers or other
stakeholders notify them. At the same time European manufactures, importers, distributors and
retailers, whether they are online or offline, are responsible to ensure that the products comply before
they are put for sale in order to avoid consumer harm.
We think that it is unacceptable that European consumers are exposed to dangerous products , as
well as other breaches of safety and consumer protection issues, without any economic operator
being liable in practice. Enabling a vibrant platform economy should not take precedence over
product safety, consumer protection and fair competition.
Other examples of an un-level playing field
EU retailers – online and offline – need to comply with EU-consumer protection rules. This includes
the right to withdraw and the right to have a faulty product repaired or replaced. They also need to
ensure that they do not sell counterfeit goods. A report published in 2017 by Europol and EUIPO
shows that counterfeit goods are increasingly distributed via online marketplaces, with over two thirds
of counterfeits coming into the EU from China. It also states that the majority of counterfeit goods
bought online evade detection at EU borders as they are usually sent directly to consumers in small
parcels via postal or courier services.16
EU- and national legislation also require companies that put products on the market to contribute to
producer responsibility schemes. The aim of these is to collect and recycle used products and ensure
that they do not cause littering or pollute the environment. In theory this is a requirement also for
sellers from non-EU countries, but the lack of controls makes this impossible to enforce. Since the
products still end up in the collection systems, European companies end up paying the collection fees
for their non-EU competitors.
Unlike retailers established in the EU, sellers on online marketplaces established in 3rd countries often
do not comply with EU consumer rules. For the consumer it is often not aware where the seller is
established, particularly when the online marketplace has a country specific website that uses the
language of the consumer. We have seen many examples of terms of conditions that limits
consumerrights. The right to withdraw is for example sometimes restricted to less than the 2 weeks
which EU law requires and is conditioned that the package has not been opened. In the case the
consumer wants to file a complaint after buying on the platform, the possibility for the consumer to
exercise that right varies. If a seller on a platform refuses to handle a complaint, the consumer has to
go to the complaint center in the country where the company is established, normally China or
HongKong. There are also problems with misleading price advertisements of e.g. 95 percent savings
where the price “before” is unrealistic. Another often seen problem is prices shown without VAT. Also
there are no actually possibility for the consumer to use their long-term rights, such as replacement,
repair and cancellation which is not at all in line with the ideas of a more sustainable consumption.
This deprives the consumers of their rights and distorts competition.
On November 8th 2019 the European Council adopted the “omnibus” directive17 which includes an
obligation for platforms to inform consumers who is responsible for giving them their consumer
rights. This is positive and will contribute to more transparency for the consumers provided that the
implementation of this provision makes it clear for the consumer if EU rules are not followed and
easy for the consumers to see how they can exercise their rights. However, this does not solve the
fundamental problem that products are put for sale on the platforms that directs its activities
towards European consumers but do not comply with EU rules.
Enforcement is crucial in order to ensure consumers their rights and a level playing field for companies.
Since many platforms operate in many Member States it is necessary to establish a cooperation
between the European Commission and between the relevant enforcement authorities in the
different Member States and to provide sufficient resources for the control and supervision to be
efficient. This applies for product safety authorities, consumer protection authorities and VAT and
Proposal for a solution
We find it necessary to make rules that target the various forms of platforms. Online marketplaces
selling tangible goods imposes other challenges than platforms functioning as search engines, social
platforms or facilitators of C2C apartment rentals. The proposals below are targeted towards online
marketplaces selling tangible goods.
A. Product safety and compliance
We think that legislation should make sure that online marketplaces have a greater responsibility and
are held liable as any other economic operator taking the same actual role in the trading chain as the
online marketplace. In cases concerning the sale of products from 3rd country sellers it would be the
role of an importer.
Also, the fact that the online marketplace is the first actor that the consumer has contact with, when
buy the goods through a platform, strengthen this argument. In many cases the consumer recognizes
the online marketplace as the counterpart in the contract of sale. Reasonably, they need to be able to
turn to the part that gives the appearance of being counterpart.
This reasoning is further supported by the fact that these platforms often make a good and profitable
business by mediating the sale of goods from their sellers to European consumers. This approach is
further supported by a report by The European Consumer Organization (BEUC) and the Federation of
German Consumer Organizations.18
Furthermore, this approach has a precedent in the VAT-directive that will come into force as of January
1st 2021. According to the new VAT-rules online marketplaces for all practical purposes are considered
19 Article 14a: https://eur-lex.europa.eu/legal-content/en/TXT/HTML/?uri=CELEX:32017L2455&from=FI
The Nordic Commerce Sector wants to see responsibility and liability for the online marketplaces when
facilitating the sale of goods to a consumer on the European market and there is no other economic
operator (e.g. manufacturer, importer, distributor or seller) established in the EU that can be
responsible and held liable. The marketplaces should take a more active responsibility to ensure that
the EU's rules on product safety, chemicals, consumer rights, price marketing etc. are followed when
facilitating the sale of goods from sellers in 3rd countries to consumers in the EU.
The passive “safe harbor” and "notice-and-takedown" role (online marketplaces in practice only have
to respond to external complaints and only then take active measures, for example, remove
dangerous products), undermines the EU's product safety and consumer rights regulations and
distorts competition to the disadvantage of companies in the EU, cf. above and the legal note on the
e-commerce directive attached to this paper.
Our proposal would be to apply the same, or similar, rules to online marketplaces when facilitating
the sale of goods from a manufacturer/supplier that is not established in the EU to European
consumers, as we currently apply to importers. Just like importers, online marketplaces are not the
manufacturer of the products and can therefore not be expected to have the same level of liability or
responsibility. They do, however, make large profits on facilitating the entry of foreign products to the
European market and should therefore also have legislated responsibility and liability. For our more
specific legal suggestion on how to proceed we refer to the legal note20.
Below in Annex I is an example of obligations that importers need to comply with, in accordance with
Decision 768/2008 that establishes a common framework for the marketing of products on the Single
Market – as well as the harmonized product legislation that has since been adopted in line with
In addition, the General Product Safety Directive prescribes a rule for all products, that manufactures
(including importers) may only place safe products on the Union market. In Annex II, there is a list of
the obligations for manufactures (including importers) and distributors under the General Product
Safety Directive. We see no compelling reason why online marketplaces could not fulfill the obligations
under harmonized product legislation (i.e. lex specialis for e.g. toys, cosmetics, chemicals etc.) that
stems from the obligations under Decision 768/2008 and the safety requirements under the General
Product Safety Directive.
Additionally, we would add that online marketplace should ensure the payment of fees for collection
and recycling of used products. From our point of view none of these obligations are so intrusive that
they would seriously jeopardize the platform economy. Liability for consumer rights and information
Online marketplaces should have an obligation to be proactively provide levels of consumer protection
and police their own platforms by setting rules and removing users that breach those rules and
prevent such users from reappearing.
Online marketplaces should be liable for the failure to inform the consumer that a third party is the
actual supplier of the goods or service, and becoming contractually liable vis-à-vis the consumer. They
should also be responsible for the failure to remove misleading information given by the supplier and
notified to the platform and for guarantees and statements made by the platform operator. A joint
20 For further on the legal framework and liability excemptions in the e-commerce directive, please see annex
XX (note from Wiggin Lawfirm, Brussels).
liability should apply for the performance of a contract, such as payment and delivery carried out by
the platform for third party suppliers in line with Art. 2 (2) of the Consumer Rights Directive. See the
report “The challenge of protecting EU consumers in global online markets, November 2017”,
Commissioned by BEUC & the Federation of German Consumer Organisations21.
Lasse Hamilton Heidermann
+32 472 07 42 80
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+46 73 693 83 82
+47 918 71 526
Annex I: Obligations of importers in accordance with Decision 768/200822
1. Importers shall place only compliant products on the Community market.
2. Before placing a product on the market, importers shall ensure that the appropriate conformity
assessment procedure has been carried out by the manufacturer. They shall ensure that the
manufacturer has drawn up the technical documentation, that the product bears the required
conformity marking or markings and is accompanied by the required documents, and that the
manufacturer has complied with the requirements set out in Article [R2(5) and (6)].
Where an importer considers or has reason to believe that a product is not in conformity with …
[reference to the relevant part of the legislation], he shall not place the product on the market until it
has been brought into conformity. Furthermore, where the product presents a risk, the importer shall
inform the manufacturer and the market surveillance authorities to that effect.
3. Importers shall indicate their name, registered trade name or registered trademark and the
address at which they can be contacted on the product or, where that is not possible, on its packaging
or in a document accompanying the product.
4. Importers shall ensure that the product is accompanied by instructions and safety information in
a language which can be easily understood by consumers and other end-users, as determined by the
Member State concerned.
5. Importers shall ensure that, while a product is under their responsibility, storage or transport
conditions do not jeopardise its compliance with the requirements set out in … [reference to the
relevant part of the legislation].
6. When deemed appropriate with regard to the risks presented by a product, importers shall, to
protect the health and safety of consumers, carry out sample testing of marketed products,
investigate, and, if necessary, keep a register of complaints, of non-conforming products and product
recalls, and shall keep distributors informed of such monitoring.
7. Importers who consider or have reason to believe that a product which they have placed on the
market is not in conformity with the Community harmonisation legislation applicable shall
immediately take the corrective measures necessary to bring that product into conformity, to
withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, importers shall
immediately inform the competent national authorities of the Member States in which they made the
product available to that effect, giving details, in particular, of the non-compliance and of any
corrective measures taken.
8. Importers shall, for ... [period to be specified in proportion to the lifecycle of the product and the
level of risk], keep a copy of the EC declaration of conformity at the disposal of the market surveillance
authorities and ensure that the technical documentation can be made available to those authorities,
9. Importers shall, further to a reasoned request from a competent national authority, provide it with
all the information and documentation necessary to demonstrate the conformity of a product in a
language which can be easily understood by that authority. They shall cooperate with that authority,
at its request, on any action taken to eliminate the risks posed by products which they have placed on
22Annex I: article R4: https://eur-lex.europa.eu/legal-
Annex II – Obligations of producers (including importers) and distributors under the General Product
Safety Directive 2001/95/EC
(e) "producer" shall mean:
(i) the manufacturer of the product, when he is established in the Community, and any other person
presenting himself as the manufacturer by affixing to the product his name, trademark or other
distinctive mark, or the person who reconditions the product;
(ii) the manufacturer's representative, when the manufacturer is not established in the Community
or, if there is no representative established in the Community, the importer
of the product;
General safety requirement, conformity assessment criteria and European standards
1. Producers shall be obliged to place only safe products on the market.
2. A product shall be deemed safe, as far as the aspects covered by the relevant national legislation
are concerned, when, in the absence of specific Community provisions governing the safety of the
product in question, it conforms to the specific rules of national law of the Member State in whose
territory the product is marketed, such rules being drawn up in conformity with the Treaty, and in
particular Articles 28 and 30 thereof, and laying down the health and safety requirements which the
product must satisfy in order to be marketed.
A product shall be presumed safe as far as the risks and risk categories covered by relevant national
standards are concerned when it conforms to voluntary national standards transposing European
standards, the references of which have been published by the Commission in the Official Journal of
the European Communities in accordance with Article 4. The Member States shall publish the
references of such national standards.
3. In circumstances other than those referred to in paragraph 2, the conformity of a product to the
general safety requirement shall be assessed by taking into account the following elements in
particular, where they exist:
(a) voluntary national standards transposing relevant European standards other than those referred
to in paragraph 2;
(b) the standards drawn up in the Member State in which the product is marketed;
(c) Commission recommendations setting guidelines on product safety assessment;
(d) product safety codes of good practice in force in the sector concerned;
(e) the state of the art and technology;
(f) reasonable consumer expectations concerning safety.
4. Conformity of a product with the criteria designed to ensure the general safety requirement, in
particular the provisions mentioned in paragraphs 2 or 3, shall not bar the competent authorities of
the Member States from taking appropriate measures to impose restrictions on its being placed on
the market or to require its withdrawal from the market or recall where there is evidence that, despite
such conformity, it is dangerous.
1. For the purposes of this Directive, the European standards referred to in the second subparagraph
of Article 3(2) shall be drawn up as follows:
(a) the requirements intended to ensure that products which conform to these standards satisfy the
general safety requirement shall be determined in accordance with the procedure laid down in Article
(b) on the basis of those requirements, the Commission shall, in accordance with Directive 98/34/EC
of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the
provision of information in the field of technical standards and regulations and of rules on information
society services(7) call on the European standardisation bodies to draw up standards which satisfy
(c) on the basis of those mandates, the European standardisation bodies shall adopt the standards in
accordance with the principles contained in the general guidelines for cooperation between the
Commission and those bodies;
(d) the Commission shall report every three years to the European Parliament and the Council, within
the framework of the report referred to in Article 19(2), on its programmes for setting the
requirements and the mandates for standardisation provided for in subparagraphs (a) and (b) above.
This report will, in particular, include an analysis of the decisions taken regarding requirements and
mandates for standardisation referred to in subparagraphs (a) and (b) and regarding the standards
referred to in subparagraph (c). It will also include information on the products for which the
Commission intends to set the requirements and the mandates in question, the product risks to be
considered and the results of any preparatory work launched in this area.
2. The Commission shall publish in the Official Journal of the European Communities the references of
the European standards adopted in this way and drawn up in accordance with the requirements
referred to in paragraph 1.
If a standard adopted by the European standardisation bodies before the entry into force of this
Directive ensures compliance with the general safety requirement, the Commission shall decide to
publish its references in the Official Journal of the European Communities.
If a standard does not ensure compliance with the general safety requirement, the Commission shall
withdraw reference to the standard from publication in whole or in part.
In the cases referred to in the second and third subparagraphs, the Commission shall, on its own
initiative or at the request of a Member State, decide in accordance with the procedure laid down in
Article 15(2) whether the standard in question meets the general safety requirement. The Commission
shall decide to publish or withdraw after consulting the Committee established by Article 5 of Directive
98/34/EC. The Commission shall notify the Member States of its decision.
Other obligations of producers and obligations of distributors
1. Within the limits of their respective activities, producers shall provide consumers with the relevant
information to enable them to assess the risks inherent in a product throughout the normal or
reasonably foreseeable period of its use, where such risks are not immediately obvious without
adequate warnings, and to take precautions against those risks.
The presence of warnings does not exempt any person from compliance with the other requirements
laid down in this Directive.
Within the limits of their respective activities, producers shall adopt measures commensurate with
the characteristics of the products which they supply, enabling them to:
(a) be informed of risks which these products might pose;
(b) choose to take appropriate action including, if necessary to avoid these risks, withdrawal from the
market, adequately and effectively warning consumers or recall from consumers.
The measures referred to in the third subparagraph shall include, for example:
(a) an indication, by means of the product or its packaging, of the identity and details of the producer
and the product reference or, where applicable, the batch of products to which it belongs, except
where not to give such indication is justified and
(b) in all cases where appropriate, the carrying out of sample testing of marketed products,
investigating and, if necessary, keeping a register of complaints and keeping distributors informed of
Action such as that referred to in (b) of the third subparagraph shall be undertaken on a voluntary
basis or at the request of the competent authorities in accordance with Article 8(1)(f). Recall shall take
place as a last resort, where other measures would not suffice to prevent the risks involved, in
instances where the producers consider it necessary or where they are obliged to do so further to a
measure taken by the competent authority. It may be effected within the framework of codes of good
practice on the matter in the Member State concerned, where such codes exist.
2. Distributors shall be required to act with due care to help to ensure compliance with the applicable
safety requirements, in particular by not supplying products which they know or should have
presumed, on the basis of the information in their possession and as professionals, do not comply with
those requirements. Moreover, within the limits of their respective activities, they shall participate in
monitoring the safety of products placed on the market, especially by passing on information on
product risks, keeping and providing the documentation necessary for tracing the origin of products,
and cooperating in the action taken by producers and competent authorities to avoid the risks. Within
the limits of their respective activities they shall take measures enabling them to cooperate efficiently.
3. Where producers and distributors know or ought to know, on the basis of the information in their
possession and as professionals, that a product that they have placed on the market poses risks to the
consumer that are incompatible with the general safety requirement, they shall immediately inform
the competent authorities of the Member States thereof under the conditions laid down in Annex I,
giving details, in particular, of action taken to prevent risk to the consumer.
The Commission shall, in accordance with the procedure referred to in Article 15(3), adapt the specific
requirements relating to the obligation to provide information laid down in Annex I.
4. Producers and distributors shall, within the limits of their respective activities, cooperate with the
competent authorities, at the request of the latter, on action taken to avoid the risks posed by
products which they supply or have supplied. The procedures for such cooperation, including
procedures for dialogue with the producers and distributors concerned on issues related to product
safety, shall be established by the competent authorities.