Mobility-based d-hop clustering algorithm for mobile ad hoc networks
Mobility-based d-Hop Clustering Algorithm for Mobile Ad Hoc Networks
Winston K.G. Seah1,2
{stuerii, winston}@i2r.a-star.edu.sg
1Institute for Infocomm Research
2Department of Computer Science
Agency for Science Technology and Research
School of Computing
National University of Singapore
Abstract-
This paper presents a mobility-based d-hop effective topology [1]. By organizing nodes into clusters,
clustering algorithm (MobDHop), which forms variable-
topology information can be aggregated. This is because the
diameter clusters based on node mobility pattern in
number of nodes of a cluster is smaller then the number of nodes
MANETs. We introduce a new metric to measure the
of the entire network. Each node only stores fraction of the total
variation of distance between nodes over time in order to
network routing information. Therefore, the number of routing
estimate the relative mobility of two nodes. We also estimate
entries and the exchanges of routing information between nodes
the stability of clusters based on relative mobility of cluster
are reduced[3]. Apart from making large networks seem smaller,
members. Unlike other clustering algorithms, the diameter
clustering in MANETs also makes dynamic topology appear less
of clusters is not restricted to two hops. Instead, the diameter
dynamic by considering cluster stability when they form[2].
of clusters is flexible and determined by the stability of
Based on this criterion, all cluster members that move in a
clusters. Nodes which have similar moving pattern are
similar pattern remain in the same cluster throughout the entire
grouped into one cluster. The simulation results show that
communication session. By doing this, the topology within a
MobDHop has stable performance in randomly generated
cluster is less dynamic. Hence, the corresponding network state
scenarios. It forms lesser clusters than Lowest-ID and
information is less variable[3]. This minimizes link breakage
MOBIC algorithm in the same scenario. In conclusion,
and packet loss.
MobDHop can be used to provide an underlying hierarchical
Clustering algorithm in MANETs should be able to
routing structure to address the scalability of routing
maintain its cluster structure as stable as possible while the
protocol in large MANETs.
topology changes[1]. This is to avoid prohibitive overhead
incurred during clusterhead changes. In this paper, we propose a
Keywords: cluster, mobility-based clustering, mobile ad hoc
mobility-based d-hop clustering algorithm (MobDHop) that
networks, MANET, mobility pattern.
forms
d-hop clusters based on a mobility metric suggested by
Basu
et al.[8]. The formation of clusters is determined by the mobility pattern of nodes to ensure maximum cluster stability.
1. Introduction
We observe that mobile users in MANET may move in groups. This is known as group mobility[10]. Mobile hosts may be
Mobile ad hoc network (MANET) consists of a number of
involved in team collaborations or activities. They may have a
wireless hosts that communicate with each other through multi-
common mission (save victims that are trapped in collapsed
hop wireless links in the absence of fixed infrastructure. They
building), perform similar tasks (gather information of threats in
can be formed and deformed spontaneously at anytime and
a battlefield) or move in the same direction (rescue team
anywhere. Some envisioned MANETs, such as mobile military
designated to move towards east side of disaster struck area).
networks or future commercial networks may be relatively large
Therefore, our algorithm attempts to capture group mobility and
(e.g. hundreds or possibly thousands of nodes per autonomous
uses this information to form more stable clusters.
system). The need to store complete routing details for an entire
MobDHop, a distributed algorithm, dynamically forms
network topology raises scalability issue. The flat hierarchy
stable clusters which can serve as underlying routing
adopted by most of the existing MANET routing protocols may
architecture. First, MobDHop forms non-overlapping two-hop
not be able to support the routing function efficiently since their
cluster like other clustering algorithms. Next, these clusters
routing tables could grow to an immense size if each node had a
initiate a merging process among each other if they could listen
complete view of the network topology. Therefore, clustering
to one another through gateways. The merging process will only
algorithms are proposed in MANETs to address scalability issue
be successful if the newly formed cluster achieves a required
by providing a hierarchical network structure for routing.
level of stability. As mentioned, most of the existing clustering
Clustering algorithms can be performed dynamically to
algorithms form two-hop clusters which may not be too useful in
adapt to node mobility[2]. MANET is dynamically organized
very large MANETs. Therefore, MobDHop is designed to form
into groups called clusters to maintain a relatively stable
d-hop clusters that are more flexible in cluster diameter. The
used to compute the relative mobility between neighboring
diameter of clusters is adaptive to the mobility pattern of
nodes, which determines the ALM of each node.
network nodes. MobDHop is simple and incurs as low overhead
All of the above algorithms create two-hop clusters in
as possible. Information exchange during the formation of
MANETs. They are more suitable for dense MANETs in which
clusters, clusterhead changes and clusterhead handovers are kept
most of the nodes are within direct transmission range of
to minimum. The remainder of this paper is organized as follows:
clusterheads. However, these algorithms may form a large
We present an overview of clustering algorithms proposed for
number of clusters in relatively large and sparse MANETs.
MANETs in Section 2. Next, details of MobDHop are presented
Therefore, two-hop clusters may not be able to achieve effective
in Section 3. Section 4 discusses our simulation results and
topology aggregation. Amis
et al. generalized the clustering
analysis. Finally, we conclude in Section 5.
heuristics so that an ordinary node can be at most
d hops away
from its clusterhead[9]. This algorithm allows more control and
2. Related Work
flexibility in the determination of clusterhead density. However, clusters are formed heuristically without taking node mobility
A number of clustering algorithms have been proposed in
and their mobility pattern into consideration. McDonald and
literature such as Linked Cluster Algorithm (LCA)[4], Lowest-
Znati[2] designed a (
α,t)-clustering algorithm that adaptively
ID Algorithm (L-ID)[5], Maximum Connectivity Clustering
changes its clustering criteria based on the current node mobility.
(MCC)[6], Least Clusterhead Change Algorithm (LCC)[7], and
This algorithm determines cluster membership according to a
LCA[4] was developed for packet radio
cluster's internal path availability between all cluster members
networks and intended to be used with small networks of less
than 100 nodes. LCA organizes nodes into clusters on the basis
of node proximity. Each cluster has a clusterhead, and all nodes
3.Mobility-based d-hop Clustering Algorithm
within a cluster are within direct transmission range of the clusterhead. Gateways are nodes that are located in the
A successful dynamic clustering algorithm should achieve a
overlapping region between clusters. Two clusters communicate
stable cluster topology with minimal communications overhead
with each other via gateways. Pair of nodes can act as gateways
and computational complexity [2]. The efficiency of the
if there are no nodes in the overlapping region. LCA was later
algorithm is also measured by the number of clusters formed
revised[5] to reduce the number of clusterheads. In the revised
[11]. Therefore, the main design goals of our clustering
version of LCA, a node is said to be covered if it is in the 1-hop
algorithm are as follows:
neighborhood of a node that has declared itself as clusterhead. A
1. The algorithm minimizes the number of clusters by
node declares itself to be a clusterhead if it has the lowest id
considering group mobility pattern.
among the non-covered nodes in its 1-hop neighborhood, known
2. The algorithm must be distributed and executed
as Lowest-ID algorithm.
Parekh suggested MCC in which the clusterhead election is
3. The algorithm must incur minimal clustering overhead, be it
based on degree of connectivity instead of node id[6]. A node is
cluster formation or maintenance overhead.
elected as a clusterhead if it is the highest connected node in all
4. Network-wide flooding must be avoided.
of the uncovered neighboring nodes. This algorithm suffers from
5. Optimal clustering may not be achieved, but the algorithm
dynamic network topology, which triggers frequent changes of
must be able to form stable clusters should any exists.
clusterheads. Frequent cluster reconfiguration and clusterhead
MobDHop, we first make a few
reselection incur prohibitive overhead.
assumptions on the network:
LCC[7] is designed to minimize clusterhead changes. A
1. Two nodes are connected by bi-directional link (symmetric
clusterhead change occurs when two clusterheads come within
range of each other, or a node becomes disconnected from any
2. The network is not partitioned.
cluster. When two clusterheads come into direct contact, one of
3. Each node can measure its received signal strength.
the clusterheads will give up its role. Some of the nodes in one cluster may not be members of the other clusterhead's cluster.
Through periodic beaconing or hello messages used in some
Therefore, one or more of those nodes must become a
routing protocols, a mobile node can estimate its distance to its
clusterhead. Such changes propagate across the network, causing
neighbor based on the measured received signal strength from
a rippling effect of clusterhead changes.
that particular neighbor. In the Friss transmission equation, the
Basu et al.[8] propose a weight-based clustering algorithm,
received power over a point-to-point radio link is given by:
MOBIC, which is similar to L-ID. Instead of node ID, MOBIC
uses a new mobility metric, Aggregate Local Mobility (ALM),
P =
P *
G *
G *
to elect a clusterhead. The ratio between the received power
(4 *π *
d )
levels of successive transmissions between a pair of nodes is
where
Pr = received power,
Pt = transmitted power,
Gt = antenna
is larger than the old distance, the neighboring node is moving
gain of the transmitter,
Gr = antenna gain of the receiver,
λ =
away from the measuring node. We group the nodes into two-
wavelength (
c/f), and
d = distance.
hop clusters based on their relative mobility in the first stage.
This shows the familiar inverse square-law dependence of
Next, we expand the cluster by merging individual nodes with
received power with distance, i.e.
Pr α 1/d2. Therefore, we derive
two-hop clusters or merging two or more two-hop clusters based
the estimated distance between two nodes from the above
on the previously described metric, i.e. the variation of estimated
equation based on received signal strength. In real world
distance between gateway nodes. Before introducing MobDHop,
scenario, it may not be possible to obtain an exact calculation of
we give a brief introduction to different terms and metrics used
the physical distance between two nodes from the measured
signal strength. However, MobDHop does not depend on
accurate estimation of distances between two nodes to operate
3.1 Preliminary Concepts
correctly. Instead, we observe the variation of the estimated distances (in other words, fluctuation of the received signal
A node may become a
clusterhead if it is found to be
strength) between two nodes over time. From the series of
the most stable node among its neighborhood. Otherwise, it is an
distance variations, we use statistical testing to predict relative
ordinary member of at most one cluster. When all nodes first
mobility pattern between two nodes. We intuitively conclude
enter the network, they are in
non-clustered state. A node that is
that two nodes are stably-connected if the received signal
able to listen to transmissions from another node which is in
strength between them varies negligibly over time. If two nodes
different cluster is known as a
gateway. We formally define the
are moving together at a similar speed towards the same
following terms: (1) estimated distance between nodes, (2)
direction, the variation of their received signal strength should
relative mobility between nodes, (3) stably-connected node pair,
be very small. This serves as one of the metrics we used to group
(4) local stability, and (5) estimated mean distance.
the nodes into its respective cluster.
Definition 1: Estimated distance between node A and B,
E[DAB],
Based on the above justification, we will not use complex
is calculated as below.Please note that this formula is not aimed
calculation in MobDHop in order to obtain accurate physical
to obtain exact physical distance between two nodes. Instead, it
distance. Instead we use the received signal strength measured at
is an approximation to show the "closeness" of two nodes.
the arrival of every packet to estimate the distance from one
node to its neighbor node. The stronger the received signal
strength, the closer the neighbor node. It is important to know
that the "closeness" between two nodes is not necessarily
measured by their absolute or physical distance. For example,
Definition 2: Relative mobility between nodes
A and
B,
node A may be very close to node B. However, it runs out of
indicates whether they are moving away from each other,
energy and transmits packets at lower power. In this case, it
moving closer to each other or maintain the same distance from
behaves like a distanced node from node A. Therefore, absolute
each other. To calculate relative mobility, we compute the
distance may not be useful in predicting link stability in this case.
difference of the distance at time,
t and the distance at time,
t - 1.
Relative mobility at node A with respect to node B at
t is
calculated as follows:
Relative mobility of clusterhead wrt node B is
Definition 3: The variation of
E[DAB] over a time period,
T,
is defined as the changes of estimated distances between
node A and B over a predefine time period. Let's consider node
A as measuring node. Node A has a series of estimated distance
Relative mobility of
values from node B measured at certain time interval for
n times,
clusterhead wrt node B is
E[DAB]={
E[DAB]t, t = 0, 1, 2, … , n}. Therefore we calculate
AB as the standard deviation of distance variation as follows:
VD = σ ( [
E D ] − [
Figure 1. Relative Mobility
E D ] −
E[
D ] , . , [
E D ] − [
Measured signal strength of successive packets is used to
estimate the relative mobility between two nodes. We calculate
Definition 4: Local stability at node
A, StA, represents the degree
the difference of estimated distance from a neighboring node at
of stability at node
A with respect to all its neighbors. Local
two successive time moments. The difference indicates the pair-wise relative mobility as shown in Figure 1. If the new distance
stability is the standard deviation of relative mobility values of
the most stable node among its neighborhood. Hence, it has the
all neighbors. Therefore it is calculated as follows:
greatest potential to be a real group leader in real life scenarios.
3.3 Merging Stage
Definition 5: Estimated Mean Distance (EMD) for cluster,
C1,
After the discovery stage, all nodes are covered by two-hop
indicates the mean distance from each neighbor to the
clusters. There are two cases that may initiate a merging process:
clusterhead,
CH1 of cluster,
C1. The EMD is calculated as
a) A non-clustered node requests to join the neighboring
b) Two neighboring gateways request to merge their clusters.
],
E[
D
], .,
E[
D
In the first case, a non-clustered node initiates the merging
process. In the second case, two neighboring gateway nodes, G1
3.2 Discovery Stage
and G2 from C1 and C2 respectively, which are in transmission
This is an initial setup stage for two-hop clusters when the
range of each other, initiate the merging process. Nodes
network is first initialized. All nodes periodically broadcast
initiating merging process start collecting samples for estimated
Hello messages, including their local stability value (initialized
distance between them. From the samples of estimated distances,
to infinity at the beginning of operation). Each node measures
they compute mean of estimated distance,
E[DG1G2], and
the received signal strength of every received Hello message and
variation of distance over time,
VDG1G2. Apart from this, they
estimates the distance with each neighbor. After receiving at
also calculate their relative mobility with respect to each other.
least two successive Hello messages, each node calculates
To be successfully merged, both gateway nodes must fulfill the
relative mobility with its neighbor at time
t using equation in
following two criteria at the end of sampling period,
TS:
Definition 3. After a discovery period,
TD, each node assumes
1)
VDG1G2 ≤ min{StC1, StC2}, and
that it has the complete knowledge of its neighborhood. Then it
2)
µ(E[DG1G2]) ≤ max{EMDC1, EMDC2}
computes its local stability value using equation in
Definition 4.
Then, it broadcasts Hello messages with the computed local
The first criterion ensures that the variation of estimated
stability value. Thus, each node knows the local stability of their
distance between two merging nodes is less than or equal to the
neighbors. After an assignment period,
T
minimum value of group stability among two clusters. This
A, each node compares
its own local stability value with those of its neighbors. If a node
indicates that the link between two nodes is at least as stable as
has the lowest value of local stability among all its neighbors, it
other links in one of the clusters which is more stable. The
assumes the status of a clusterhead. Its local stability value
second criterion tells us that the distance between two nodes
becomes group stability (GS).
conforms to the distance characteristic of the larger cluster.
Then, the clusterhead computes EMD with respect to all
Therefore both clusters have higher probability to be originated
cluster members (one-hop neighbors of clusterhead). The
EMD
from the same group of real life situation as suggested in RPGM.
is computed to capture another characteristic of the network if
In most of the group communication applications, members
the nodes are moving in groups. This characteristic is suggested
belong to the same group tend to remain in each other
by Reference Point Group Mobility (RPGM) model[10]. The
transmission ranges over time by maintaining a constant distance
RPGM model suggested that a group center is used to
from group leader.
characterize the movement of its corresponding group members,
including their direction, speed, and distance from group center.
3.4 Maintaining Stage
This is similar to the real life group communication in which
We first consider two cases that may cause topology
group leader guides the movement of its group members.
changes in MANET and thus invoke cluster maintenance stage:
Therefore, group members will not move too far away from the group leader. Their movement area is usually bounded
. EMD is
1) A node switches on and joins the network.
used as one of the metrics in the merging process to allow a new
2) A node switches off and leaves the network.
cluster member to join the cluster.
When a node switches on, it will initiate the merging
If a cluster member is able to hear hello messages from
process in the same manner as described in Section 3.3. It
another node from another cluster, it assumes the role of a
checks all the links with its neighboring nodes and collects
gateway. Otherwise, it declares itself to be a cluster member. If
samples for estimated distance from each neighbor. Then it
two neighboring nodes in non-clustered state have the same
computes the variation of distance over time,
VD, with each
value of local stability, the clusterhead assignment is deferred
neighbor. At the end of sampling period, it chooses the neighbor
for a back-off period. The local stability will be recomputed at
with lowest
VD, and joins its cluster.
the end of back-off period. This is to ensure the clusterhead is
When a node switches off and the node is a clusterhead, this
will cause its cluster members to lose the clusterhead and fail to
receive cluster advertisements for a predefined period. The
neighbors. Therefore, clusters are less dynamic and the number
immediate neighbors of the clusterhead will initiate the
of clusterheads changes also decreases.
discovery process as described in Section 3.2 in which a new
We also compare the performance of MobDHop with the
clusterhead will be elected. The information of the new
Lowest-ID algorithm and MOBIC in a 50-node MANET under
clusterhead will then be propagated to other cluster members,
constant mobility (20m/sec). In Figure 4, we note that there is a
which are further away from it. However, during the clusterhead
small difference between Lowest-ID and MOBIC with respect to
election period, other cluster members which are at least 2 hops
the average number of clusters formed. This is because both
away from the old clusterhead may detect the loss of clusterhead
algorithms are variations of a local weight based clustering
and decide to join neighboring cluster if the merging criteria
technique that forms two-hop clusters. MobDHop forms less
specified in Section 3.3 can be met. If a node found itself in non-
clusters in the similar scenario since it forms variable-diameter
clustered state, it will initiate merging with neighboring clusters
clusters based on node mobility pattern. This is one of the
whenever possible. Otherwise, it will declare itself to be a
desirable properties in clustering algorithm especially when the
clusterhead of a one-node cluster. From time to time, it will try
scalability is the main concern.
to merge with other clusters if possible.
Table 1. Simulation Parameters for MobDHop
4.
Simulation Results and Discussions
Parameter Meaning
The performance of MobDHop is evaluated via simulations
Simulation
using NS-2 with CMU wireless extensions [12]. The scenarios
were generated with input parameters as listed in Table 1, such
as network size, speed, transmission range, broadcast interval,
MaxSpeed Maximum
clusterhead contention interval and simulation time. The
movement of mobile nodes is randomly generated and
Transmission Range
continuous within the whole simulation period. We implemented
MobDHop as described in Section 3. The local stability value,
Interval 0.75-1.25
group stability value, node status, node clusterhead id, and
Discovery Interval
cluster EMD are added into "Hello" messages. "Hello"
Assignment Interval
messages have been widely used in on-demand routing protocols
to maintain neighbor connectivity. Each node broadcasts "Hello"
Contention Period
messages at certain broadcast interval to tell the neighbors of its
existence. MobDHop does not use additional control packets for
information exchange to form or maintain clusters.
Figure 2 and 3 show the performance of MobDHop for
MANETs which are different in number of nodes and
transmission ranges. The mobile nodes are moving continuously
at 20m/sec throughout the entire network simulation period (300
seconds). We note that the average number of clusters is
relatively high when the transmission range is small (10 - 20 m).
For small ranges, most nodes tend to be out of each other's
transmission range and the network may become disconnected.
Therefore, most nodes form one-node cluster, which only
consists of itself. Due to our algorithm design, which require
one-node clusters to attempt to merge with neighboring clusters
whenever possible, clusterhead will switch their status to non-clustered state in order to merge with their neighbors (if any).
This causes the high rate of clusterhead changes in disconnected networks. However, we argue that this will not affect network
performance as this will only occur when the network is
Transmission Range (m)
disconnected (A disconnected network is unable to function too).
When transmission range increases, more nodes can hear
Figure 2. Average number of clusters
each other. The average number of clusters formed decreases
and the clusters become larger in size. Since the transmission
range is large, mobile nodes tend to remain in the range of their
same cluster. As long as the nodes are moving towards the same
direction in a stable behavior, they can be grouped into the same
cluster. This is justified by the assumption of group movement,
in which members of a group tend to move towards a similar
destination in real-life scenarios.
We have simulated MobDHop and presented some
preliminary results in Section 4. In conclusion, the performance
of MobDHop is comparable to other existing algorithms. It also
creates lesser and more stable clusters in order to achieve high
scalability. The clusterhead change is relatively low. However,
we will perform extensive simulation-based comparisons between existing clustering algorithms and MobDHop to
evaluate different aspects of performance such as cluster stability, overhead consumption, latency and others. We may use
Transmission Range (m)
other mobility models which are more realistic such as RPGM in
Number of Clusterhead Changes
our simulations. Finally, designing a multicast routing protocol
which can work on-top of MobDHop in order to address
Figure 3. Number of clusterhead changes
scalability issues in MANET is part of our ongoing research.
References:
[1] C. R. Lin and M. Gerla. Adaptive clustering for mobile
wireless networks.
IEEE Journal on Selected Areas in
Communications, 15(7):1265-1275, Sept. 1997.
[2] A. B. McDonald and T. F. Znati. A mobility-based framework
for adaptive clustering in wireless ad hoc networks.
IEEE
Journal on Selected Areas in Communications, 17(8):1466-
1486, Aug. 1999.
[3] C. E. Perkins, editor. Ad Hoc Networking. Addison-Wesley,
[4] D. J. Baker and A. Ephremides. The architectural organization
of a mobile radio network via a distributed algorithm.
IEEE Transactions on Communications, 29(11):1694-1701, 1981.
Transmission Range (m)
[5] A. Ephremides, J. Wieselthier, and D. Baker. A design concept
for reliable mobile radio network with frequency hopping
Figure 4. Comparisons between different clustering
signaling. In
Proceedings of IEEE 75, pages 56-73, 1987.
algorithms in a 50-node MANET.
[6] A. K. Parekh. Selecting routers in ad hoc wireless networks. In
ITS, 1994.
[7] C.-C. Chiang, H.-K. Wu, W. Liu, and M. Gerla. Routing in
5. Conclusions
clustered multihop, mobile wireless networks with fading
Clustering can provide large-scale MANETs with a
channel.
IEEE Singapore International Conference on Networks (SICON)
hierarchical network structure to facilitate routing operations. In
, pages 197-211, Apr. 1997.
[8] P. Basu, N. Khan, and T. D. C. Little. Mobility based metric
this paper, we proposed a distributed clustering algorithm which
for clustering in mobile ad hoc networks.
Workshop on
forms variable-diameter clusters that may change its diameter
Distributed Computing Systems, pages 413-418, 2001.
adaptively with respect to mobile nodes' moving patterns.
[9] A. D. Amis, R. Prakash, T. H. P. Vuong, and D. T. Huynh.
Inspired by Basu et. al[8], we proposed two mobility metrics
Max-min d-cluster formation in wireless ad hoc networks. In
based on the relative mobility concept: (1) variation of estimated
Proceedings of IEEE INFOCOM '00, Vol. 1, pages 32-41, Mar.
distance between nodes over time and (2) estimated mean
distance for cluster, in order to measure the stability of a cluster.
[10] X. Hong, M. Gerla, G. Pei, and C. Chiang. A group mobility
These metrics are used to decide cluster memberships. Therefore,
model for ad hoc wireless networks. In
Proceedings of ACM/IEEE MSWiM, Seattle, WA, Aug.1999.
the formation of clusters in MobDHop is determined by the
[11] F. G. Nocetti, J. S. Gonzalez, I. Stojmenovic, "Connectivity
mobility pattern of nodes to ensure maximum cluster stability.
based k-hop clustering in wireless networks,"
To achieve the desired scalability, MobDHop forms
Telecommunication Systems 22 (2003) 1-4, 205-220, 2003.
variable-diameter clusters, which allows cluster members to be
[12] K. Fall, and K. Varadhan, "The ns Manual,"
more than two hops away from their clusterhead. The diameter
http://www.isi.edu/nsnam/ns/, 2002.
of clusters is dependent on the mobility behavior of nodes in the
Source: http://homepages.ecs.vuw.ac.nz/~winston/papers/WCNC2004-MobDHop.pdf
UNIVERSIDAD AUTONOMA DE YUCATAN LICENCIATURA DE MÉDICO CIRUJANO PROGRAMA DE ESTUDIOS CIENCIAS FISIOLÓGICAS SEGUNDO AÑO CICLO ESCOLAR 2014-2015 UNIVERSIDAD AUTÓNOMA DE YUCATÁN FACULTAD DE MEDICINA CUERPO DIRECTIVO M. C. GUILLERMO STOREY MONTALVO
European Medicines Agency Veterinary Medicines and Inspections London, 13 October 2006 EMEA/CVMP/765/99-Rev.16 STATUS OF MRL PROCEDURES MRL assessments in the context of Council Regulation (EEC) No 2377/90 Background and legislative framework In order to protect the safety of the consumer of foodstuffs of animal origin, one of the most important principles laid down in the European Union (EU) legislation with regard to the marketing authorisation of veterinary medicines is that foodstuffs obtained from animals treated with veterinary medicinal products must not contain residues which might constitute a health hazard for the consumer. Before a veterinary medicinal product intended for food producing animals can be authorised in the EU, all pharmacologically active substances contained in the product have to undergo a safety and residues evaluation, and have to be included in Annex I, II, or III of Council Regulation (EEC) No 2377/901. The safety and residue evaluation in accordance with Regulation 2377/90 is carried out by the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMEA), supported by safety and residues experts, upon receipt of a valid application for the establishment of maximum residue limits (MRLs). Substances for which definitive MRLs have been established are included in Annex I of Regulation 2377/90. MRLs can be proposed as provisional, if all aspects are not yet fully addressed. In this case the substance is inserted in Annex III with an expiry date defining for the termination of the provisional status. However, no provisional MRLs can be proposed, if major issues with regard to safety remain to be addressed, as it must be assured that residues at the proposed levels do not present a hazard to the health of the consumer. Only, once the applicant has satisfactorily answered the outstanding questions, the substance can be included in Annex I. These questions are likely to relate to the provision of fully validated analytical methods. Where, following the evaluation, it appears that it is not necessary for the protection of public health to establish MRLs, such substance is included in Annex II. It should be noted that an entry in Annex II is not equivalent to the status "generally recognised as safe". In fact only a sub-group of Annex II substances do fall under this category. For further details on the assessment of a substance you are advised to consult the MRL Summary report of the substances concerned. Please also note that Annex II comprises a specific entry, which provides that certain substances approved in the EU as food additives with a valid E-number are considered included in Annex II without listing the substances specifically. Relevant substances falling under these provisions are e.g. vitamin C, citric acid or several sodium and potassium salts, and these substances are only mentioned in the enclosed list if an MRL application was submitted.