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The Authorities of the Member States are required to submit a notification to the RAPEX system in the following cases:
where all the RAPEX notification criteria laid down in Article 12 of the GPSD(1) are met, a Member State prepares and submits to the Commission a RAPEX notification classified in the RAPEX application as an ‘Article 12 notification’.
where all the RAPEX notification criteria are met and, in addition, a product poses a life-threatening risk and/or there have been fatal accidents, and in other cases where a RAPEX notification requires emergency action by all Member States, the notifying Member State prepares and submits to the Commission a RAPEX notification classified in the RAPEX application as a ‘Notification requiring emergency action’.
where all RAPEX notification criteria laid down in Article 22 of Regulation (EC) No 765/2008(2) are met, a Member State prepares and submits to the Commission a RAPEX notification classified in the RAPEX application as an ‘Article 22 notification’.
Where all notification criteria laid own in Article 11 of the GPSD(3) are met, a Member State prepares and submits to the Commission a notification, which, when notified in RAPEX is classified as an ‘Article 11 notification’.
Moreover, Member States are encouraged to submit a notification where the criteria laid down in Article 23 of Regulation (EC) No 765/2008 are met(4).
Following the abovementioned reasoning in Part II Chapter 2, Member States are encouraged to prepare and submit, either directly or indirectly, to the Commission a notification classified in RAPEX as an ‘Article 23 notification’ when the criteria laid down in the same article are met.
Before sending a notification to the Commission, the RAPEX Contact Point (see Part II, Chapter 5.1) of the notifying Member State checks that all notification criteria are met.
If the criteria laid down in these Guidelines for the notifications listed in Part II Chapters 2.1 and 2.2 of these Guidelines are not met, the RAPEX Contact Point (see Part II, Chapter 5.1) may choose to use the RAPEX application to send the information concerned for information purposes. Such notifications are classified in RAPEX as ‘Notifications for information’ and they may be sent in the following situations:
Where all the RAPEX notification criteria laid down in Article 12 of the GPSD or in Article 22 of Regulation (EC) No 765/2008 are met but a notification does not contain all the information (mainly on product identification and distribution channels) necessary for other Member States to ensure follow-up(5) to such a notification. A notification where the product name, brand and picture are missing and thus the notified product cannot be correctly identified and it cannot be distinguished from other products of the same category or type that are available on the market, is an example of a notification that can be distributed through the RAPEX application as ‘Notification for information’. Assessment as to whether a notification contains sufficient information for other Member States to ensure follow-up activities is always on a case-by-case basis.
Where a Member State is aware of the fact that a consumer product that is available on the EU market poses a serious risk to the health and safety of consumers or, in the case of products covered by Regulation (EC) 765/2008, is aware of the fact that a consumer or a professional product poses a serious risk to the health and safety or other relevant public interests of the end-users, but preventive and restrictive measures have not yet been taken by the producer or distributor or adopted or decided to be adopted by an authority of a Member State. If information on such a product is distributed through the RAPEX application before measures are taken, the notifying Member State subsequently informs the Commission (as soon as possible and not later than the deadlines specified in Appendix 4 to these Guidelines) of the final decision taken with regard to the notified product (mainly, what type of preventive or restrictive measures were taken or why such measures were not taken). Where the notifying Member State takes measures at a later stage, it informs the Commission, who will update the notification in application of Article 12 of the GPSD or Article 22 of Regulation (EC) No 765/2008.
Where a Member State decides to notify preventive and restrictive measures taken in relation to a consumer product posing a serious risk to the health and safety of consumers which has only local effects (‘local event’). If, however, as explained in Part I, Chapter 6.2, a notification by ‘local event’ involves information on product safety likely to be of interest for other Member States, it should be sent as if it were a notification under Article 11 of the GPSD.
Where a notification concerns a product whose safety aspects (especially the level of risk posed to the health and safety of consumers) are subject to discussion at EU level to ensure a common approach between Member States to risk assessment and/or enforcement action(6).
Where a decision cannot be taken with certainty that one or more of the notification criteria are met, but a notification involves information on product safety likely to be of interest for other Member States.
When sending a ‘Notification for information’, the RAPEX Contact Point (see Part II, Chapter 5.1) clearly states the reasons for so doing.
Notifications sent to the Commission through the RAPEX application include the following types of data:
Information enabling the notified product to be identified, i.e. product category, product name, brand, model and/or type number, barcode, batch or serial number, customs code, description of the product and its packaging accompanied by pictures showing the product, its packaging and labels. Detailed and accurate product identification is a key element for market surveillance and enforcement, as it allows national authorities to identify the notified product, to distinguish it from other products of the same or similar type or category that are available on the market and to find it on the market and take or agree on appropriate measures.
Information establishing the product's origin, i.e. country of origin, name, address and contact details, such as telephone number and e-mail address, of a manufacturer and exporters. In particular, Member States provide all available information on manufacturers and exporters located in third countries that cooperate closely with the EU on product safety. The following documents are also to be attached to the form where available: copies of orders, sales contracts, invoices, shipping documents, customs declarations, etc. These documents should be transmitted in pdf format or any other format accepted by the application. Detailed information on third country producers allows the Commission to promote more effective enforcement in those countries and helps to reduce the number of products posing a risk to consumers exported into the EU.
Wherever possible, information about where exactly the product has been made available (a major store, local shop or market, online, etc.).
Information on the safety requirements applicable to the notified product, including the reference number and name of the applicable legislation and standards.
A risk description of the notified product, including a description of the results of laboratory or visual tests, test reports and certificates proving non-compliance of the notified product with the safety requirements, a complete risk assessment with conclusions and information on known accidents or incidents (see Part I Chapter 3.3.1 of these Guidelines).
Information on the supply chains of the notified product in the Member States and, in particular, information on the countries of destination, plus information on importers and also, if available, on distributors of the notified product in Europe.
Information on measures taken, in particular, the type (compulsory or voluntary), category (e.g. withdrawal from the market, recall from consumers), scope (e.g. national, local), and date of entry into force and duration of the measure (e.g. permanent, temporary).
Indication of whether a notification, part of it and/or attachment(s) are covered by confidentiality. Requests for confidentiality are always accompanied by a justification clearly stating the reasons for such a request.
Information on whether the product is counterfeit, when available. For this purpose, the Commission will provide Member States with any specific tools available at European level to facilitate the identification of counterfeit products.
Information on reported accidents related to the product, indicating when possible the reasons for the accident (risk related to the use made by the user or inherent to the product).
Additional information on whether the notification has been submitted in the context of a coordinated enforcement activity at European level.
Information on whether the authorities of a Member State envisage sending other notifications related to the same product or similar products. This should be indicated in the original notification.
Member States are encouraged to look for and provide information on the supply chains of the notified product in non-EU countries that cooperate closely with the EU on product safety.
Notifications should be as complete as possible. The elements to be contained in the notification are listed in Appendix 1 to these Guidelines and are included in the RAPEX application. All fields of the notification template should be completed with the required data. Where the required information is not available at the time a notification is submitted, this is clearly indicated and explained on the form by the notifying Member State. Once the missing information becomes available, the notifying Member State updates its notification. The updated notification is examined by the Commission before being validated and distributed through the system.
RAPEX Contact Points provide all national authorities that participate in the RAPEX network with instructions on the scope of data required to complete the notification. This helps to ensure that the information provided by these authorities to the RAPEX Contact Point is correct and complete (see Part II, Chapter 5.1).
Where part of the information required by these Guidelines is not yet available, Member States should nonetheless comply with the established deadlines and not delay sending a RAPEX notification on a product that poses a life-threatening risk to the health and safety of consumers or other end-users and/or where a RAPEX notification requires emergency action by Member States.
Before submitting a notification, the RAPEX Contact Point checks (to avoid any unnecessary duplication) that the product concerned has not already been notified through the RAPEX application by another Member State. If the product has already been notified, rather than creating a new notification, the RAPEX Contact Point submits a follow-up notification to the existing notification and provides any additional information that may be relevant for authorities in other Member States, such as additional vehicle identification numbers, a detailed list of importers and distributors, additional test reports, etc. (See also Part II, Chapter 5.1).
The notifying Member State informs the Commission (as soon as possible and not later than by the deadlines specified in Appendix 4 to these Guidelines) of any developments that require changes to a notification transmitted through the RAPEX application. In particular, Member States inform the Commission of any changes (e.g. following a ruling by a court during an appeal procedure) to the status of the notified measures, to the risk assessment and to new decisions regarding confidentiality.
The Commission examines the information provided by the notifying Member State and updates the information concerned in the RAPEX application and on the RAPEX website, where necessary.
Responsibility for the information provided lies with the notifying Member State(7).
The notifying Member State and the national authority responsible ensure that all data provided through the RAPEX application are accurate so as to avoid any confusion with similar products of the same category or type that are available on the EU market.
The authority(ies) involved in the notification procedure (e.g. by performing the risk assessment of the notified product or by providing information on distribution channels) take responsibility for the information provided through the RAPEX application. The RAPEX Contact Point checks and validates all notifications received from the authorities responsible before transmitting them to the Commission (See also Part II, Chapter 5.1).
Any action taken by the Commission, such as examining notifications, validating and distributing them through the RAPEX application and publishing them on the RAPEX website, does not imply any assumption of responsibility for the information transmitted, which remains with the notifying Member State.
The parties involved in the notification process and their responsibilities therein are the following:
Economic operators are not directly involved in the submission of notifications in the RAPEX application.
However, in case of a product posing a risk, economic operators shall immediately inform the competent authorities in all Member States where the product was made available. The conditions and details for providing such information are laid down in Annex I to the GPSD.
Such information will be dealt with by the Member State where the notifying producer/distributor is established (‘Main Member State’).
The transmission of information on products posing a risk can be submitted by economic operators through the ‘Product Safety Business Alert Gateway’, a tool available on the RAPEX website (see Part II Chapter 5.3.2). Economic operators should include a detailed description of the risk of the product and can make use of the ‘RAG tool’ available for this purpose (see Part I Chapter 5.3).
Risk assessments carried out by economic operators are not binding on Member State authorities who are responsible for carrying out their own risk assessment. It is therefore possible for an authority of a Member State to come to a different conclusion regarding the risk assessment provided in an alert submitted via the ‘Business Gateway’.
Member States authorities notify the Commission through the RAPEX application about both compulsory and voluntary measures taken on their own territory against products posing a risk.
Member States establish the roles for the creation, submission and follow-up of notifications in RAPEX.
Measures adopted by the authorities in charge of external border controls that prevent the marketing in the EU of a consumer product posing a serious risk to the health and safety of consumers (e.g. decisions to stop the import at the EU border) should be notified to the Commission through the RAPEX application in the same manner as measures adopted by market surveillance authorities that restrict the marketing or use of a product.
The Commission may inform the RAPEX Contact Points (see Part II, Chapter 5.1) regarding products posing serious risks, imported into or exported from the Community and the European Economic Area(8).
The Commission may transmit information to the Member States about products of EU and non-EU origin posing a risk that, according to the information available, are likely to be on the EU market. This mainly concerns information that the Commission receives from third countries, international organisations, businesses or other rapid alert systems.
This information might be circulated amongst Member States by means other than the RAPEX application.
According to the national arrangements, different national authorities involved in the RAPEX process (local/regional market surveillance authorities, external border control authorities, etc.) may be allowed to create a notification.
In certain cases, the Commission may create a notification as explained in point 3.3.4.
The RAPEX Contact Point is responsible for the submission of all notifications for validation by the Commission. (See Part II, Chapter 5.1).
The Commission checks all notifications received through the RAPEX application before transmitting them to Member States to ensure that they are correct and complete.
When assessing the correctness of a notification, the Commission checks in particular that:
The notification meets all the relevant requirements set out in the GPSD or in Article 22 of Regulation (EC) No 765/2008 and in these Guidelines;
the notified product has not already been notified (to avoid any unnecessary duplication, including between ICSMS and RAPEX);
the notification submitted for validation by the notifying Member State is classified in accordance with the criteria set out in Part II Chapter 2 of these Guidelines;
the information provided including the risk assessment takes due account of the applicable legislation and the relevant standards;
the correct notification procedure has been used.
Once a notification is confirmed as correct, the Commission checks that it is complete. Part II, Chapters 3.2.1 and 3.2.2 of these Guidelines act as a point of reference. Special attention is given to the parts of a notification concerning product identification, risk description, measures, traceability and distribution channels.
The Commission is not responsible for performing a risk assessment of the product, but only for checking that the notification includes an appropriate risk assessment containing all the elements listed in Part II Chapter 3.2.1 of these Guidelines (with the exceptions referred to in point 3.4.3.3). See also Part I Chapter 5.1 of these Guidelines.
Member States should submit a risk assessment for every notification but in certain cases, the Commission may validate notifications that are submitted without a detailed and individual risk assessment:
The risk level of a product may be considered to be serious if it contains a chemical substance either banned or in a concentration above the limit established by European legislation. Therefore, in cases where measures are taken against products containing a chemical substance subject to a restriction contained in EU Legislation, a notification may be submitted without a detailed risk assessment.
Validation of notifications that do not include a detailed risk assessment may equally be possible for cosmetic products containing banned or restricted substances, which are backed up by an EU scientific committee opinion supporting that such presence of substances above the established limits poses a risk to the health and safety of consumers. For this specific product sector, other factors (e.g. concentration or time of exposure) may need to be taken into consideration.
Nevertheless, if measures have been taken against a product containing not authorised chemical substances for which no scientific opinion has been issued confirming that the product poses a risk, a proper risk assessment may be required depending on a case-by-case analysis to prove that the product poses a serious or less than serious risk. In cases where the risk assessment is needed, if such risk assessment is not provided, these cases shall only be validated ‘for information’ in RAPEX.
As regards products that are subject to restrictive measures by market surveillance authorities based on the presence of a chemical substance mentioned in the list of ingredients which is subject to restrictions contained in EU Legislation and where there is no scientific data assessing the risk, notifications need to be assessed on a case-by-case basis. In case where the risk assessment is needed, if such risk assessment is not provided, these cases shall only be validated ‘for information’ in RAPEX.
Where there is well-documented evidence that certain features of certain products consistently lead to a specific risk and risk level (e.g., the presence of any drawstrings or functional cords in the head, neck or upper chest on garments intended for young children always implies a serious risk), no further risk assessment is required for that given product.
Should, during examination, the Commission have questions regarding a notification, it may suspend validation of the notification and ask the notifying Member State for additional information or clarification. This additional information is provided by the notifying Member State by the deadline specified in the Commission's request for information.
Where necessary, the Commission may carry out an investigation to assess the safety of a product. This investigation may be conducted in particular where there are serious doubts as to the risks posed by the product notified via the RAPEX application. These doubts can either arise during the examination of a notification by the Commission, or be brought to the attention of the Commission by a Member State (e.g. through a follow-up notification) or by a third party (e.g. a producer).
As part of such investigations, the Commission may, in particular:
ask any Member State to provide information or clarification;
ask for an independent risk assessment and independent testing (laboratory or visual) of the product under investigation;
consult the Scientific Committees, the Joint Research Centre or any other institution specialising in the safety of consumer products;
convene the GPSD Committee, Consumer Safety Network and/or RAPEX Contact Points meetings, as well as consult the relevant Working Groups to discuss developments in an investigation.
Where an investigation concerns a product notified through the RAPEX application, the Commission may suspend validation of a notification or, where such a notification has already been validated and distributed through the RAPEX application, temporarily remove the overview published on the RAPEX website. After an investigation, and depending on the outcome, the Commission (after consulting the notifying Member State, where necessary) may in particular validate and distribute through the RAPEX application the previously suspended notification, uphold the validated notification in the RAPEX application (with any changes) or permanently withdraw the notification from RAPEX.
The Commission informs all Member States of the following:
its decision to launch an investigation, clearly stating the reasons for its decision;
its decision to close an investigation, presenting its conclusions and changes to the investigated notification(s) (if any);
all the relevant developments during an investigation.
The Commission validates and distributes through the RAPEX application, by the deadlines specified in Appendix 5 to these Guidelines, all notifications assessed as correct and complete during the examination.
Where, during an examination, a request for additional information or clarification was sent to the notifying Member State (followed by a reminder, if necessary), the Commission may take the following decisions:
where the additional information or clarification requested has been provided, the Commission re-examines the notification and may validate it with the changed classification where necessary (e.g. from a ‘Notification for information’ to an ‘Article 12 notification’) or keep it on hold until further clarification;
where the additional information or clarification requested has not been provided within a specified deadline or it is insufficient, the Commission takes a decision on the basis of the information provided and, depending on the circumstances, may either validate it after changing the classification (e.g. from an ‘Article 12 notification’ to ‘Notification for information’) or decide not to validate it.
Once a common approach to risk assessment and/or enforcement has been agreed between Member States, depending on the circumstances and the views of the Member States, the Commission may take one of the following actions:
keep the notifications concerned in the RAPEX application;
change the classification of the notifications stored in the RAPEX application;
withdraw notifications from RAPEX(9).
The public has the right to be informed about products posing a risk. To meet this obligation, the Commission publishes overviews of new notifications on the RAPEX website(10).
For external communication reasons, the RAPEX website will in future be called ‘Safety Gate’.
Member States equally provide the public with information in the national languages on products posing a serious risk to consumers and on measures taken to address this risk. Such information may be distributed via the internet, on paper, by electronic media, etc.
The information made available to the public is a summary of a notification and includes in particular the elements which allow the identification of the product, as well as the information about the risks and measures taken to prevent or restrict those risks. The Commission and the Member States may decide to disclose other elements of the notifications to the public, only when this information, due to its nature, is not confidential (professional secrets) and does not need to be protected.
The following notifications are made available on the RAPEX website, in line with the requirements laid down in Article 16 of the GPSD:
notifications submitted falling under the scope of Article 12 of the GPSD;
notifications submitted falling under the scope of Article 22 of Regulation (EC) No 765/2008;
notifications submitted falling under the scope of Article 11 of the GPSD for products posing less than serious risk, the cross-border effect of which has also been recognised. As Chapter 3.4 provides for, the cross-border effect ascertains whether such a scenario is to be notified under Article 11;
notifications submitted falling under the scope of Article 23 of Regulation (EC) No 765/2008 concerning products presenting risks that are less than serious and regardless of whether the measures taken were compulsory or voluntary(11);
notifications submitted for information only if the notifying Member State so requests by ticking the ad hoc box in RAPEX, especially when voluntary measures are adopted and the products concerned are sufficiently identified. The publication of these notifications might need to be considered from the standpoint of securing an appropriate risk management.
Member States and the Commission should not disclose to the public any information about a product notified through the RAPEX application if such disclosure undermines the protection of court proceedings, monitoring and investigation activities or professional secrecy, except for information relating to the safety properties of products which must be made public if circumstances so require to protect the health and safety of consumers, or, in case of products covered by Regulation (EC) No 765/2008, also to protect other relevant public interests of the end-users(12).
A notifying Member State may request confidentiality of a notification. Such a request clearly indicates the part(s) of the notification that should be kept confidential.
Furthermore, each request for confidentiality is accompanied by a justification clearly stating the reasons(13).
Requests for confidentiality are subject to examination by the Commission. The Commission checks that the request is complete (i.e. that it states which parts of the notification are covered by confidentiality and that it contains a justification) and justified (i.e. that it is in line with the provisions of the GPSD and these Guidelines). A decision as to the validity of the request is taken by the Commission after consulting the respective RAPEX Contact Point. (See Part II, Chapter 5.1).
Article 16(2) of the GPSD states that the protection of professional secrecy or confidentiality shall not prevent the dissemination to the competent authorities of information relevant for ensuring the effectiveness of market monitoring and surveillance activities. Notifications covered partially or fully by confidentiality are examined by the Commission and, after being validated and distributed through the RAPEX application, they are subject to the usual follow-up activities by the Member States. The confidentiality of a notification or parts of it does not prevent it from being handled and distributed through the RAPEX application to the competent national authorities.
The only significant difference in the handling and follow-up procedures is that the Commission and Member States should not disclose any parts of a notification that are confidential to the public. These parts have to remain confidential and thus they should not be published in any form. Member State authorities that receive confidential information through the RAPEX application ensure that it is protected when performing their activities.
The notifying Member State withdraws its request for confidentiality immediately after the authority in that Member State becomes aware that the justification for such a request is no longer valid, and informs the Commission accordingly. The Commission informs all Member States of the withdrawal of confidentiality on receipt of such a request by the notifying Member State.
A notification that is no longer covered by full or partial confidentiality is made available to the public in line with the ‘general rules’ applying to publication of notifications set out in these Guidelines.
Member States ensure appropriate follow-up to ‘Article 12 notifications’, ‘Article 12 notifications requiring emergency action’, notifications under Article 22 of Regulation (EC) No 765/2008 and to information on products posing a risk sent by the Commission (Chapter 3.3.4) as soon as possible and by the deadlines specified in Appendix 4 to these Guidelines at the latest.
Notifications for information as well as notifications under Article 11 of the GPSD and notifications under Article 23 of Regulation (EC) No 765/2008 (notification for less than serious risks) do not require any specific follow-up activities. These notifications often do not contain the data needed for effective and efficient enforcement regarding the notified product (e.g. the notified product and/or measures are not sufficiently identified) or the level of the risk is not considered to be serious.
Although there is no specific need for a follow-up in the referred cases, it is still important that Member States verify whether they disagree with the consideration of the risk as less than serious so they may eventually make a follow-up upon the information of a different risk assessment. Member States are therefore encouraged to ensure follow-up to such notifications where the notified product is likely to have been made available to consumers on their market and product identification allows measures to be taken.
On receipt of a notification, a Member State examines the information provided in the notification and takes appropriate action in order to:
establish whether the product was marketed on its territory;
assess what preventive or restrictive measures should be taken with regard to the notified product found on its market, taking into account the measures taken by the notifying Member State and any special circumstances that could justify different types of measures or no action being taken;
perform additional risk assessment and testing of the notified product, if necessary;
collect any additional information that may be relevant for other Member States (e.g. information on distribution channels of the notified product in other Member States).
To ensure efficient and effective follow-up, best practice follow-up techniques should be employed by national authorities, including:
National authorities organise regular (planned and random) checks on the market in order to establish whether consumer products notified through the RAPEX application are made available to consumers. When the Member State is mentioned as a country of destination, reinforced checks on the market shall be carried out, notably by contacting the economic operator(s) indicated in the notification.
National authorities provide, when necessary, business associations with overviews of the most recent notifications and enquire whether any of the notified products were produced or distributed by their members. National authorities provide businesses only with summaries of notifications, such as the weekly overviews published on the RAPEX website. Whole notifications should not be transmitted to third parties, as certain information (e.g. details of the risk description or information on distribution channels) is often confidential and should be protected.
National authorities regularly alert consumers and businesses about consumer products notified through the RAPEX application via their websites and/or other media, e.g. referring consumers and business to the RAPEX website. Information published in this way allows consumers to check whether they have and use products posing a risk and often provides the authority with useful feedback.
National authorities regularly perform online checks to try to identify whether products notified via RAPEX are available on online markets. Online check techniques may include web-crawling, data mining, data scraping, etc.
National authorities apply various follow-up techniques in parallel and ideally do not limit their activities to only one of them.
The Member State in which a manufacturer, a representative or an importer of the notified product is established (‘Main Member State’) ensures appropriate follow-up to notifications distributed through the RAPEX application. The ‘Main Member State’ often has better legal and technical means of obtaining information on the notified case, which will help other Member States to undertake effective follow-up activities.
Notifications distributed through the RAPEX application are kept in the system for an unlimited period of time. The Commission may, however, in the situations presented in this Chapter, permanently withdraw a notification from RAPEX.
There is proof that one or more of the notification criteria(14) are not met and thus a notification is not justified. This concerns cases in particular where it is established that the original risk assessment was performed incorrectly and that the notified product does not pose a risk. It also covers situations where the notified measures were successfully challenged in court or in other proceedings and they are no longer valid.
No measures have been taken with regard to a product notified through the RAPEX application (for information) before it was decided to adopt measures or take action(15).
After a discussion held at EU level, Member States agree that it is not useful to exchange information on certain safety aspects that have been notified through the RAPEX application(16).
There is proof that products covered by a notification are no longer marketed and there is proof that all items that had been made available have already been withdrawn from the market and retrieved in all Member States.
Withdrawal of a notification that has been submitted or validated cannot be requested on the basis of the fact that the notified product has been subject to changes needed for it to comply with all the applicable safety requirements, unless proof is provided that all the products (items) concerned that had been made available have been withdrawn and retrieved in all Member States and that they are no longer marketed.
The Commission may withdraw notifications from RAPEX only at the request of the notifying Member State, as the latter takes full responsibility for the information transmitted through the system. Other Member States, however, are encouraged to inform the Commission of any facts that may justify withdrawal.
Every request for withdrawal is accompanied by a justification stating the reasons and by all available documents supporting those reasons. The Commission examines each request and checks the justification and the supporting documents in particular. The Commission may request additional information, clarification or the opinion of the notifying Member State and/or other Member States before taking any decision.
Should, on the basis of the justification provided, the Commission decide to withdraw a notification from RAPEX, it removes it from:
the RAPEX application (or makes it otherwise invisible to all users of the system);
the RAPEX website (if necessary).
The Commission informs all Member States of the withdrawal of a notification by mail or through other equally effective means and, if necessary, also the public by publishing a corrigendum on the RAPEX website.
Where justified, the Commission may temporarily remove a notification from the RAPEX website, especially where the notifying Member State suspects that a risk assessment submitted in a notification has been performed incorrectly and thus the notified product may not pose a risk. A notification can be temporarily removed from the RAPEX website until the risk assessment of the notified product has been clarified.
The Commission may temporary remove notifications from the RAPEX application only at the request of the notifying Member State, as the latter takes full responsibility for the information transmitted through the application. Other Member States, however, are encouraged to inform the Commission of any facts that may justify such removal.
Every request for temporary removal is accompanied by a justification stating the reasons and by all available documents supporting those reasons. The Commission examines each request and checks the justification and the supporting documents in particular. The Commission may request additional information, clarification or the opinion of the notifying Member State and/or other Member States before taking any decision.
Should, on the basis of the justification provided, the Commission decide to remove a notification from the RAPEX website, it informs all Member States by e-mail or by other equally effective means and, if necessary, also the public by publishing a corrigendum on the RAPEX website.
The notifying Member State immediately informs the Commission when the reasons for the removal of a notification from the RAPEX website are no longer valid. In particular, it informs the Commission of the results of any new risk assessment to enable the Commission to determine whether to maintain a notification in the RAPEX application and to re-publish it on the RAPEX website or to withdraw it permanently from RAPEX (following a request from the notifying Member State).
The Commission may re-publish a notification on the RAPEX website following a justified request from the notifying Member State after the risk assessment has been clarified.
The Commission informs the other Member States of the re-publishing of a notification on the RAPEX website by e-mail or by other equally effective means and also the public by replacing the corrigendum with a new one on the RAPEX website.
The Commission will place all notifications older than ten years in a separate section of the RAPEX website. These notifications will still be available for public consultation.
Article 12(1) of the GPSD and Article 22 of Regulation (EC) No 765/2008 require Member States to immediately notify the Commission through the RAPEX application of preventive and restrictive measures concerning products posing serious risks. This provision applies to both compulsory and voluntary measures, although the timing of the notification is different.
These measures are notified through the RAPEX application immediately after being adopted or after the decision to adopt them has been taken, even if an appeal against them at national level is likely, if they are already under appeal or they are subject to publication requirements.
This approach is consistent with the objective of RAPEX, i.e. to ensure the rapid exchange of information between Member States and the Commission in order to prevent the supply and use of products that pose a risk.
Under Article 5(3) of the GPSD and Article 22 of Regulation (EC) No 765/2008, economic operators are obliged to notify the competent Member State authorities of voluntary action and measures taken to prevent risks to consumers posed by products they have made available on the market (ideally by means of a ‘Business Gateway’ notification). The authority of a Member State receiving this kind of notification uses this information as the basis for a notification (if all the notification criteria are met) and sends it immediately after receipt of the ‘Business Gateway’ notification.
Where voluntary measures are adopted in the form of an agreement between an economic operator and an authority of a Member State or on the basis of a recommendation from an authority to a producer or distributor, a notification is submitted immediately after the conclusion of such an agreement or the adoption of such a recommendation.
To ensure common application of the notification obligation, Part III, Appendix 4 to these Guidelines lays down specific deadlines for submitting notifications to the Commission via the RAPEX application(17).
Member States notify the Commission of preventive and restrictive measures adopted as soon as possible and by the deadlines specified in Part III, Appendix 4 to these Guidelines at the latest. Appropriate arrangements are in place at national level concerning the transmission of information between national authorities in charge of product safety and the RAPEX Contact Point to ensure that the deadlines are met. (See Part II, Chapter 5.1).
The deadlines provided apply irrespective of any appeal procedure or official publication requirement.
All notifications concerning products posing a serious risk requiring emergency action are preceded by a telephone call from the RAPEX Contact Point to the Commission RAPEX Team's mobile telephone number to facilitate immediate action and follow-up. This rule applies in particular to notifications transmitted at weekends or during holiday periods. (See also Part II, Chapter 5.1).
See Part II, Chapter 2.2.1 of these Guidelines.
See Part II, Chapter 2.2.1 of these Guidelines.
See Part II, Chapter 2.2.2 of these Guidelines.
See Part II, Chapter 2.2.2 of these Guidelines.
For more information on follow-up actions, see Part II Chapter 4.4.5 of these Guidelines.
For more information about notifications where safety aspects are subject to discussions at EU level, see Part II Chapters 3.4.4 and 3.4.7.1.1 of these Guidelines.
See point 10 of Annex II of Directive 2001/95/EC.
See point 9 of Annex II of Directive 2001/95/EC.
For more information on notifications on safety aspects subject to discussions at EU level, see Part II Chapters 3.1.2(d) and 3.4.7.1.1.
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/?event=main.search
Practice already agreed at the GPSD Committee of 24 September 2012, of which RAPEX Contact Points were informed at the RAPEX Contact Point meeting of 4 October (agenda point 4) and applied since 2013.
Paragraph 1 of Article 16(1) of Directive 2001/95/EC and Article 23 paragraph 3 in relation to Article 19(5) of Regulation (EC) No 765/2008.
Article 16(1) and (2) of Directive 2001/95/EC.
For more information on the notification criteria, see Part I Chapter 2.
For more information on notifications sent through the RAPEX application before measures are taken, see Chapter 3.1.2(b).
For more information on notifications on safety aspects subject to discussions at EU level, see Part II Chapters 3.1.2.d and 3.4.4.
For more information about deadlines, see Part III Appendix 4 of these Guidelines.
All deadlines mentioned in these Guidelines are expressed in calendar days.