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11.1.2011 Official
Journal
of
the
European
Union
L
6/7
COMMISSION REGULATION (EU) No 16/2011
of 10 January 2011
laying down implementing measures for the Rapid alert system for food and feed
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
term ‘risk’ used in this Regulation is to be understood as
a direct or indirect risk to human health in connection
with food, food contact material or feed in accordance
Having regard to the Treaty on the Functioning of the European
with Regulation (EC) No 178/2002 or as a serious risk to
Union,
human health, animal health or the environment in
connection with feed in accordance with Regulation
(EC) No 183/2005.
Having regard to Regulation (EC) No 178/2002 of the European
Parliament and of the Council of 28 January 2002 laying down
the general principles and requirements of food law, establishing
(5) Rules
should
be
established
to
allow
the
RASFF
to
the European Food Safety Authority and laying down
operate correctly both in relation to cases where a
procedures in matters of food safety ( 1 ), and in particular
serious risk within the meaning of Article 50(2) of Regu
Article 51 thereof,
lation (EC) No 178/2002 is identified and in relation to
other cases where, even though a risk of lesser gravity or
urgency is identified, an efficient exchange of information
Whereas:
is necessary between and among the members of the
RASFF network. Notifications are classified into alert,
information and border rejection notifications to allow
(1) Regulation
(EC)
No
178/2002
establishes
a
Rapid
alert
for a more efficient handling by members of the
system for food and feed (hereinafter — ‘RASFF’),
network.
managed by the Commission and involving the
Member States, the Commission and the European
Food Safety Authority, to provide the control authorities
with an effective tool for the notification of risks to
(6) For
the
RASFF
to
operate
efficiently,
requirements
should
be formulated for the procedure for transmission of the
human health deriving from food or feed. Article 50 of
different types of notifications. Alert notifications should
that Regulation sets out the scope and requirements for
be transmitted and treated with priority. Border rejection
the RASFF to operate.
notifications are particularly relevant to controls carried
out at border inspection posts and designated points of
entry along the European Economic Area border.
(2) Article
51
of
Regulation
(EC)
No
178/2002
requires
the
Templates and data dictionaries enhance the legibility
Commission to establish implementing measures for
and understanding of the notifications. Flagging
Article 50 of that Regulation, in particular as regards
members of the network for certain notifications draws
the specific conditions and procedures applicable to the
their attention to particular notifications ensuring thereby
transmission of notifications and supplementary
that they are handled quickly.
information.


(3) Member
States
are
primarily
responsible
for
the (7)
In accordance with Regulation (EC) No 178/2002, the
enforcement of the EU legislation. They perform official
Commission, the Member States and EFSA have
controls, the rules for which are laid down in Regulation
designated contact points, which represent the members
(EC) No 882/2004 of the European Parliament and of
of the network in order to benefit from a correct and fast
the Council of 29 April 2004 on official controls
communication. In application of Article 50 of that
performed to ensure the verification of compliance
Regulation and in order to avoid possible mistakes in
with feed and food law, animal health and animal
the transmission of the notifications, only one designated
welfare rules (
contact point should exist for each member of the

2 ). The RASFF supports the Member
States’ actions by allowing the rapid exchange of
network. This contact point should facilitate the rapid
information on risks posed by food or feed and on
transmission to a competent authority inside a member
measures taken or to be taken to counter such risks.
country.
(4) Article
29
of
Regulation
EC
No
183/2005
of
the (8) In
order
to
ensure
the
correct
and
efficient
functioning
of
European Parliament and of the Council of 12 January
the network between its members, common rules for
2005 laying down requirements for feed hygiene ( 3 )
duties of the contact points should be established.
extends the scope of the RASFF to serious risks to
Provisions concerning the coordinating role of the
animal health and to the environment. Therefore, the
Commission should also be set out, including the verifi
cation of the notifications. In this respect, the
Commission should also assist members of the network
( 1 ) OJ L 31, 1.2.2002, p. 1.
( 2 ) OJ L 165, 30.4.2004, p. 1.
in taking appropriate measures by identifying recurrent
( 3 ) OJ L 35, 8.2.2005, p. 1.
hazards and operators reported in the notifications.

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L 6/8
EN
Official Journal of the European Union
11.1.2011
(9) In
case
that,
notwithstanding
the
checks
carried
out
by
(a) ‘information notification for follow-up’ means an
the notifying member and by the Commission, a trans
information notification related to a product that is or
mitted notification turns out to be erroneous or
may be placed on the market in another member
unfounded, then a procedure providing for either its
country;
amendment or its withdrawal from the system should
be laid down.
(b) ‘information notification for attention’ means an
information notification related to a product that:
(10) According
to
paragraphs
3
and
4
of
Article
50
of
Regu
lation (EC) No 178/2002 the Commission is required to
(i) is present only in the notifying member country; or
inform third countries of certain RASFF notifications.
Therefore, without prejudice to specific provisions in
(ii) has not been placed on the market; or
agreements concluded pursuant to Article 50.6 of Regu
lation (EC) No 178/2002, the Commission should ensure
direct contact with food safety authorities in third
(iii) is no longer on the market;
countries in order to send out notifications to these
third countries and at the same time ensure the
6. ‘border rejection notification’ means a notification of a
exchange of relevant information with regard to these
rejection of a batch, container or cargo of food or feed
notifications and any direct or indirect risk to human
as referred to in Article 50(3)(c) of Regulation (EC)
health deriving from food or feed.
No 178/2002;
(11) Article
10
of
Regulation
(EC)
No
178/2002
requires
the
7. ‘original notification’ means an alert notification, an
public authorities to inform the public of risks to human
information notification or a border rejection notification;
health inter alia. The Commission should provide
summary information about the RASFF notifications
8. ‘follow-up notification’ means a notification that contains
transmitted and annual reports highlighting the trends
additional information in relation to an original notification;
in food safety issues notified through RASFF and the
evolution of the network itself to inform members, stake
9. ‘professional operators’ means food business operators and
holders and the general public.
feed business operators as defined in Regulation (EC) No
178/2002 or business operators as defined in Regulation
(12) This
Regulation
has
been
discussed
with
the
European
(EC) No 1935/2004 of the European Parliament and of
Food Safety Authority.
the Council ( 1 ).
(13) The
measures
provided
for
in
this
Regulation
are
in
Article 2
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Duties of members of the network

1. Members
of
the
network
shall
ensure
the
efficient
func
HAS ADOPTED THIS REGULATION:
tioning of the network within their jurisdiction.
Article 1
2. Members
of
the
network
shall
each
designate
one
contact
point and communicate that designation to the Commission
Definitions
contact point, as well as detailed information regarding the
For the purposes of this Regulation the following definitions
persons operating it and their contact details. For that
shall apply in addition to those set out in Regulations (EC)
purpose they shall use the contact point information template
No 178/2002 and (EC) No 882/2004:
to be provided by the Commission contact point.
1. ‘network’ means the rapid alert system for the notification of
3. The
Commission
contact
point
shall
maintain
and
update
a direct or indirect risk to human health deriving from food
the list of contact points and make it available to all members
or feed, as established by Article 50 of Regulation (EC)
of the network. Members of the network shall inform the
No 178/2002;
Commission contact point immediately of any changes in
their contact points and contact details.
2. ‘member of the network’ means a Member State, the
Commission, the European Food Safety Authority and any
4. The
Commission
contact
point
shall
provide
members
of
applicant country, third country or international organisation
the network with templates to be used for notification purposes.
having concluded an agreement with the European Union
in accordance with Article 50(6) of Regulation (EC)
5. Members
of
the
network
shall
ensure
effective
communi
No 178/2002;
cation between their contact points and competent authorities
within their jurisdiction on the one hand and between their
3. ‘contact point’ means the designated contact point that
contact points and the Commission contact point on the
represents the member of the network;
other hand for the purposes of the network. In particular
they shall:
4. ‘alert notification’ means a notification of a risk that requires
or might require rapid action in another member country;
(a) set up an effective communication network between their
contact points and all relevant competent authorities within
5. ‘information notification’ means a notification of a risk that
does not require rapid action in another member country;
( 1 ) OJ L 338, 13.11.2004, p. 4.

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EN
11.1.2011 Official
Journal
of
the
European
Union
L
6/9
their jurisdiction allowing immediate transmission of a
Council Directive 97/78/EC of 18 December 1997 laying down
notification to the competent authorities for appropriate
the principles governing the organisation of veterinary checks
action, and maintain it in permanent good order;
on products entering the Community from third countries ( 1 )
and to designated points of entry as referred to in Regulation
(b) define the roles and responsibilities of their contact points
(EC) No 882/2004.
and those of the relevant competent authorities within their
jurisdiction, as regards the preparation and transmission of
Article 6
notifications sent to the Commission contact point, as well
Follow-up notifications
as the assessment and distribution of notifications received
from the Commission contact point.
1. Whenever
a
member
of
the
network
has
any
additional
information relating to the risk or product referred to in an
6. All
contact
points
shall
ensure
the
availability
of
an
on- original notification, it shall immediately transmit a follow-up
duty officer reachable outside office hours for emergency
notification through its contact point to the Commission
communications on a 24-hour/7-day-a-week basis.
contact point.
2. When
follow
up
information
relating
to
an
original
notifi
Article 3
cation has been requested by a member of the network, such
Alert notifications
information shall be provided to the extent possible and
without undue delay.
1. Members
of
the
network
shall
send
alert
notifications
to
the Commission contact point without undue delay and in any
3. When
action
is
taken
upon
receipt
of
an
original
notifi
event within 48 hours from the moment the risk was reported
cation as referred to in Article 50(5) of Regulation (EC) No
to them. Alert notifications shall include all information
178/2002, the member which took the action shall immediately
available regarding, in particular, the risk and the product
transmit detailed information thereof to the Commission
from which the risk derives. However, the fact that not all
contact point by way of a follow-up notification.
relevant information has been collected shall not unduly delay
transmission of alert notifications.
4. If
the
action
referred
to
in
paragraph
3
consists
of
a
product being detained and returned to a dispatcher residing
2. The
Commission
contact
point
shall
transmit
alert
notifi
in another member country:
cations to all members of the network within 24 hours after
reception, upon verification as referred to in Article 8.
(a) the member taking the action shall provide relevant
information about the returned product by way of a
3. Outside
office
hours,
members
of
the
network
shall
follow-up notification unless that information was already
announce the transmission of an alert notification or follow-
included in full in the original notification;
up to an alert notification by a telephone call to the emergency
phone number of the Commission contact point. The
(b) the member country to which the products were returned
Commission contact point shall inform the members of the
shall inform on the action taken on the returned products,
network flagged for follow-up by a telephone call to their
by way of a follow-up notification.
emergency phone numbers.
5. The
Commission
contact
point
shall
transmit
follow-up
Article 4
notifications to all members of the network without undue
delay and within 24 hours for follow-up notifications to alerts.
Information notifications
Article 7
1. Members of the network shall send information notifi
cations to the Commission contact point without undue
Notification submission
delay. The notification shall include all information available
regarding, in particular, the risk and the product from which
1. Notifications
shall
be
submitted
using
the
templates
the risk derives.
provided by the Commission contact point.
2. All
relevant
fields
of
the
templates
shall
be
completed
to
2. The
Commission
contact
point
shall
transmit
information enable clear identification of the product(s) and risk(s) involved
notifications to all members of the network without undue
and to provide the traceability information. Data dictionaries
delay upon verification as referred to in Article 8.
provided by the Commission contact point shall be used to
the maximum extent possible.
Article 5
Border rejection notifications
3. Notifications
shall
be
classified
according
to
the
definitions
provided in Article 1 in one of the following categories:
1. Members
of
the
network
shall
send
border
rejection
notifi
cations to the Commission contact point without undue delay.
(a) original notification
The notification shall include all information available regarding,
in particular, the risk and the product from which the risk
(i) alert notification;
derives.
(ii) information notification for follow-up;
2. The
Commission
contact
point
shall
transmit
border
rejection notifications to border inspection posts as defined in
( 1 ) OJ L 24, 30.1.1998, p. 9.

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L 6/10
EN
Official Journal of the European Union
11.1.2011
(iii) information notification for attention;
Commission contact point upon agreement from the notifying
member if the information upon which the action to be taken is
(iv) border rejection notifications;
based appears to be unfounded or if the notification was trans
mitted erroneously.
(b) follow-up notification
2. Any
member
of
the
network
may
request
amendments
to
4. Notifications
shall
identify
members
of
the
network
that a notification upon agreement from the notifying member. A
are asked to provide follow-up to the notification.
follow-up notification shall not be considered an amendment to
a notification and may therefore be transmitted without the
5. All
relevant
documents
shall
be
added
to
the
notification agreement of any other member of the network.
and sent to the Commission contact point without undue delay.
Article 8
Article 10
Verification of the notification
Exchange of information with third countries
Before transmitting a notification to all members of the
1. If
the
notified
product
originates
from
or
is
distributed
to
network, the Commission contact point shall:
a third country, the Commission shall inform the third country
without undue delay.
(a) verify the completeness and legibility of the notification,
including whether the appropriate data from the dictionaries
2. Without
prejudice
to
specific
provisions
in
agreements
referred to in Article 7(2) were selected;
concluded pursuant to Article 50(6) of Regulation (EC) No
178/2002, the Commission contact point shall establish
(b) verify the correctness of the legal basis given for the cases of
contact with a designated single contact point in the third
non-compliance found; however an incorrect legal basis
country, if any, with a view to reinforce communication,
shall not prevent transmission of the notification if a risk
including through the use of information technology. The
was identified;
Commission contact point shall send notifications to that
contact point in the third country for attention or for follow-
(c) verify that the subject of the notification falls within the
up based on the seriousness of the risk.
scope of the network as laid down in Article 50 of Regu
lation (EC) No 178/2002;
Article 11
(d) ensure that the essential information in the notification is
Publications
provided in a language easily understandable by all
members of the network;
The Commission may publish:
(e) verify compliance with the requirements laid down in this
(a) a summary of all alert, information and border rejection
Regulation;
notifications, providing information on the classification
and the status of the notification, the products and risks
(f) identify recurrences of the same professional operator
identified, the country of origin, the countries where the
and/or hazard and/or country of origin in notifications.
products were distributed, the notifying member of the
network, the basis for the notification and the measures
In order to respect the delay for transmission, the Commission
taken;
can make small changes to the notification provided that they
are agreed with the notifying member prior to transmission.
(b) an annual report on the notifications transmitted through
the network.
Article 9
Notification withdrawal and amendments
Article 12
1. Any
member
of
the
network
may
request
that
a
notifi
This Regulation shall enter into force on the 20th day following
cation transmitted through the network be withdrawn by the
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

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