Commission Regulation (EU) No 16/2011 (repealed)Show full title

Article 1 Definitions

For the purposes of this Regulation the following definitions shall apply in addition to those set out in Regulations (EC) No 178/2002 and (EC) No 882/2004:

1.

‘network’ means the rapid alert system for the notification of a direct or indirect risk to human health deriving from food or feed, as established by Article 50 of Regulation (EC) No 178/2002;

2.

‘member of the network’ means a Member State, the Commission, the European Food Safety Authority and any applicant country, third country or international organisation having concluded an agreement with the European Union in accordance with Article 50(6) of Regulation (EC) No 178/2002;

3.

‘contact point’ means the designated contact point that represents the member of the network;

4.

‘alert notification’ means a notification of a risk that requires or might require rapid action in another member country;

5.

‘information notification’ means a notification of a risk that does not require rapid action in another member country;

(a)

‘information notification for follow-up’ means an information notification related to a product that is or may be placed on the market in another member country;

(b)

‘information notification for attention’ means an information notification related to a product that:

(i)

is present only in the notifying member country; or

(ii)

has not been placed on the market; or

(iii)

is no longer on the market;

6.

‘border rejection notification’ means a notification of a rejection of a batch, container or cargo of food or feed as referred to in Article 50(3)(c) of Regulation (EC) No 178/2002;

7.

‘original notification’ means an alert notification, an information notification or a border rejection notification;

8.

‘follow-up notification’ means a notification that contains additional information in relation to an original notification;

9.

‘professional operators’ means food business operators and feed business operators as defined in Regulation (EC) No 178/2002 or business operators as defined in Regulation (EC) No 1935/2004 of the European Parliament and of the Council(1).

Article 2 Duties of members of the network

1. Members of the network shall ensure the efficient functioning of the network within their jurisdiction.

2. Members of the network shall each designate one contact point and communicate that designation to the Commission contact point, as well as detailed information regarding the persons operating it and their contact details. For that purpose they shall use the contact point information template to be provided by the Commission contact point.

3. The Commission contact point shall maintain and update the list of contact points and make it available to all members of the network. Members of the network shall inform the Commission contact point immediately of any changes in their contact points and contact details.

4. The Commission contact point shall provide members of the network with templates to be used for notification purposes.

5. Members of the network shall ensure effective communication between their contact points and competent authorities within their jurisdiction on the one hand and between their contact points and the Commission contact point on the other hand for the purposes of the network. In particular they shall:

(a) set up an effective communication network between their contact points and all relevant competent authorities within their jurisdiction allowing immediate transmission of a notification to the competent authorities for appropriate action, and maintain it in permanent good order;

(b) define the roles and responsibilities of their contact points and those of the relevant competent authorities within their jurisdiction, as regards the preparation and transmission of notifications sent to the Commission contact point, as well as the assessment and distribution of notifications received from the Commission contact point.

6. All contact points shall ensure the availability of an on-duty officer reachable outside office hours for emergency communications on a 24-hour/7-day-a-week basis.

Article 3 Alert notifications

1. Members of the network shall send alert notifications to the Commission contact point without undue delay and in any event within 48 hours from the moment the risk was reported to them. Alert notifications shall include all information available regarding, in particular, the risk and the product from which the risk derives. However, the fact that not all relevant information has been collected shall not unduly delay transmission of alert notifications.

2. The Commission contact point shall transmit alert notifications to all members of the network within 24 hours after reception, upon verification as referred to in Article 8.

3. Outside office hours, members of the network shall announce the transmission of an alert notification or follow-up to an alert notification by a telephone call to the emergency phone number of the Commission contact point. The Commission contact point shall inform the members of the network flagged for follow-up by a telephone call to their emergency phone numbers.

Article 4 Information notifications

1. Members of the network shall send information notifications to the Commission contact point without undue delay. The notification shall include all information available regarding, in particular, the risk and the product from which the risk derives.

2. The Commission contact point shall transmit information notifications to all members of the network without undue delay upon verification as referred to in Article 8.

Article 5 Border rejection notifications

1. Members of the network shall send border rejection notifications to the Commission contact point without undue delay. The notification shall include all information available regarding, in particular, the risk and the product from which the risk derives.

2. The Commission contact point shall transmit border rejection notifications to border inspection posts as defined in Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(2) and to designated points of entry as referred to in Regulation (EC) No 882/2004.

Article 6 Follow-up notifications

1. Whenever a member of the network has any additional information relating to the risk or product referred to in an original notification, it shall immediately transmit a follow-up notification through its contact point to the Commission contact point.

2. When follow up information relating to an original notification has been requested by a member of the network, such information shall be provided to the extent possible and without undue delay.

3. When action is taken upon receipt of an original notification as referred to in Article 50(5) of Regulation (EC) No 178/2002, the member which took the action shall immediately transmit detailed information thereof to the Commission contact point by way of a follow-up notification.

4. If the action referred to in paragraph 3 consists of a product being detained and returned to a dispatcher residing in another member country:

(a) the member taking the action shall provide relevant information about the returned product by way of a follow-up notification unless that information was already included in full in the original notification;

(b) the member country to which the products were returned shall inform on the action taken on the returned products, by way of a follow-up notification.

5. The Commission contact point shall transmit follow-up notifications to all members of the network without undue delay and within 24 hours for follow-up notifications to alerts.

Article 7 Notification submission

1. Notifications shall be submitted using the templates provided by the Commission contact point.

2. All relevant fields of the templates shall be completed to enable clear identification of the product(s) and risk(s) involved and to provide the traceability information. Data dictionaries provided by the Commission contact point shall be used to the maximum extent possible.

3. Notifications shall be classified according to the definitions provided in Article 1 in one of the following categories:

(a) original notification

(i)

alert notification;

(ii)

information notification for follow-up;

(iii)

information notification for attention;

(iv)

border rejection notifications;

(b) follow-up notification

4. Notifications shall identify members of the network that are asked to provide follow-up to the notification.

5. All relevant documents shall be added to the notification and sent to the Commission contact point without undue delay.

Article 8 Verification of the notification

Before transmitting a notification to all members of the network, the Commission contact point shall:

(a)

verify the completeness and legibility of the notification, including whether the appropriate data from the dictionaries referred to in Article 7(2) were selected;

(b)

verify the correctness of the legal basis given for the cases of non-compliance found; however an incorrect legal basis shall not prevent transmission of the notification if a risk was identified;

(c)

verify that the subject of the notification falls within the scope of the network as laid down in Article 50 of Regulation (EC) No 178/2002;

(d)

ensure that the essential information in the notification is provided in a language easily understandable by all members of the network;

(e)

verify compliance with the requirements laid down in this Regulation;

(f)

identify recurrences of the same professional operator and/or hazard and/or country of origin in notifications.

In order to respect the delay for transmission, the Commission can make small changes to the notification provided that they are agreed with the notifying member prior to transmission.

Article 9 Notification withdrawal and amendments

1. Any member of the network may request that a notification transmitted through the network be withdrawn by the Commission contact point upon agreement from the notifying member if the information upon which the action to be taken is based appears to be unfounded or if the notification was transmitted erroneously.

2. Any member of the network may request amendments to a notification upon agreement from the notifying member. A follow-up notification shall not be considered an amendment to a notification and may therefore be transmitted without the agreement of any other member of the network.

Article 10 Exchange of information with third countries

1. If the notified product originates from or is distributed to a third country, the Commission shall inform the third country without undue delay.

2. Without prejudice to specific provisions in agreements concluded pursuant to Article 50(6) of Regulation (EC) No 178/2002, the Commission contact point shall establish contact with a designated single contact point in the third country, if any, with a view to reinforce communication, including through the use of information technology. The Commission contact point shall send notifications to that contact point in the third country for attention or for follow-up based on the seriousness of the risk.

Article 11 Publications

The Commission may publish:

(a)

a summary of all alert, information and border rejection notifications, providing information on the classification and the status of the notification, the products and risks identified, the country of origin, the countries where the products were distributed, the notifying member of the network, the basis for the notification and the measures taken;

(b)

an annual report on the notifications transmitted through the network.

Article 12

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 January 2011.

For the Commission

The President

José Manuel Barroso