1
 
 
Draft Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers)
 
Policy
 
Paper 
–
 
Fall 2020
 
 
Contents
 
1. Issue
 
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1
 
2. Objective
 
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...................
 
1
 
3. Description of Proposed Amendments
 
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.....
 
2
 
3.1 Creation of a new heading in Division 25, Part B entitled “Human Milk Fortifiers”
 
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2
 
3.2 Definitions
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...........
 
2
 
3.3 Pre
-
market review of HMFs
 
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3
 
3.4 Conditions related to th
e sale of HMFs
 
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6
 
3.5 Addition of vitamins, mineral nutrients and amino acids
 
................................
................................
...
 
7
 
3.6 Food additives
 
................................
................................
................................
................................
.....
 
7
 
3.7 Labelling requirements
 
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.......................
 
8
 
3.8 Coming into Force
 
................................
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............................
 
10
 
3.9 Service standards
 
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................................
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10
 
 
1. 
Issue
 
 
Human milk fortifiers (HMFs) are foods which are added to human milk to increase its 
nutritional value and provide necessary nutrients for infants who are born prematurely or for 
other infants as medically required (e.g. small for gestational age, high p
rotein needs). This is a 
best practice in clinical care. Currently, there are no provisions 
specific 
to HMFs in the 
Food and 
Drug Regulations
 
(FDR)
,
 
meaning the general food framework applies. 
Amendments to the FDR 
are needed to
 
permit
 
HMFs 
to
 
have 
added
 
v
itamins, mineral nutrients, amino acids and 
update 
language around 
food additives, and to 
include provisions to 
safeguard the health and safety of 
the vulnerable population using HMFs. 
 
 
2. 
Objective
 
 
Health Canada is proposing
 
to establish a regulatory framework for the sale of HMFs in Canada. 
This framework would prescribe information and evidence requirements for assessment by 
the 
Minister of Health
 
to help ensure the safety and nutritional adequacy of HMFs and the health and
 
safety of the infant population that rel
ies
 
on them.
 
 
 2
 
 
3. 
Description
 
of Proposed Amendments
 
The proposed amendments would update existing provisions and add new provisions in Part B 
(Food) and Part D (Vitamins, Minerals and Amino Acids) of the FDR to cre
ate a regulatory 
framework for HMFs.  
 
 
In particular
, the proposed amendments would include
:
 
pre
-
market assessment of HMFs and 
HMFs that have undergone a major change; setting conditions of sale, including stopping sale if 
evidence shows the HMF product is no longer safe or nutritionally adequate; permitting the 
addition 
of vitamins, mineral nutr
ients, amino acids, 
updated language around 
food additives and 
other ingredients; and setting out labelling requirements.
 
 
 
3.1 
Creation of a new heading in Division 25, Part B entitled “Human Milk Fortifiers”
 
 
It is proposed to create a new heading in Div
ision 25 titled “Human Milk Fortifiers”, under 
which the majority of the new regulatory requirements would be listed. This heading would be 
situated between the provisions for “Infant Foods” (sections B.25.002 and B.25.003) and 
“Human Milk Substitutes and 
Food Containing Human Milk Substitutes” i.e. infant formula 
(sections B.25.045 to B.25.060). The proposed provisions under this heading would capture the 
following elements: requirements for pre
-
market notification; conditions related to the sale of 
HMFs; 
updated language around
 
the use of food additives; and labelling requirements. 
 
 
3.2 
Definitions 
 
 
The proposed amendments would add a definition for “human milk fortifier.” HMFs would be 
defined as 
“
a food that is labelled and advertised as intended to
 
be
 
added to human milk to 
increase its nutritional value in order to meet the particular requirements of an infant in whom a 
physical or physiological
 
condition exists as a result of a disease, disorder or abnormal physical 
state
”
.
 
 
The proposed definition i
s intended to provide flexibility for the use of HMFs for certain preterm 
infants and for other infants when health professionals deem it to be necessary. 
 
 
The definition for “major change” 
in Division 25 
would be expanded
 
to apply to HMFs. The 
current definition for “major change” applies only to infant formula
 
and would be amended to 
also apply to HMFs. 
 
 
Other existing definitions that would be amended to account for HMFs are:
 

 
The definition of “expiration date” would be
 
expanded to apply to HMFs. Unlike most 
prepackaged foods, HMFs would be required to have an expiration date, not a best before 
date. Expiration dates are required only on certain foods that have strict compositional or 
nutritional specifications which mig
ht not be met after the expiration date. The use of an 3
 
 
expiration date is more appropriate for HMFs given the important role they play in the 
health and safety of preterm infants or other infants under medical supervision.
 
 

 
The definition for “nutritional 
supplement” would be amended to exclude HMFs. In the 
FDR, “nutritional supplement”
 
is defined as a food sold or represented as a supplement 
to a diet that may be inadequate in energy and essential nutrients.
 
Excluding HMFs from 
the definition for nutrition
al supplements ensures that HMFs do not need to follow the 
regulatory provisions in Division 24 of the FDR for nutritional supplements.
 
 

 
The current definition for “infant food” would be amended by replacing “represented for 
consumption by infants” with “l
abelled or advertised for consumption by infants” in 
order to bring clarity to the meaning of the word “represented”. A similar change would 
be made to the definition of “human milk substitute” for consistency purposes.
 
 
Finally, 
similar to infant formulas
, 
the FDR will be amended to allow 
HMFs 
to 
be referred to as 
a food for special dietary use
 
(FSDU). 
HMFs fit the definition
 
(in section B.24.001 of the FDR)
 
of a FSDU as
 
they are specially formulated to meet the particular needs of preterm or other 
infants
. 
 
 
3.3 
Pre
-
market review of HMFs 
 
Pre
-
market review of HMFs prior to sale is necessary to help ensure the safety and nutritional 
adequacy of HMFs for their intended use. Under the proposed amendments, 
it would be 
prohibited to 
advertise for sale or to sel
l an HMF unless
 
the Minister has provided its 
manufacturer with a written authorization. 
 
 
3.3.1 
New HMFs 
 
Therefore, the HMF would only be permitted to be sold and advertised for sale once the 
manufacturer of the HMF submits an application 
with the requir
ed information to 
the Minister of 
Health
, the application is reviewed by 
the Minister
, and the Minister issues 
a 
written 
authorization
 
to the manufacturer indicating that the information provided establishes that the 
HMF 
may be sold and advertised for sale
. 
 
 
The proposed amendments would set out 
application
 
requirements for the pre
-
market review of 
an HMF. This includes providing the Minister of Health with: 
 

 
administrative information used to identify the HMF and the manufacturer; 
 

 
the list of ingredients
 
stated quantitatively; 
 

 
the specifications for nutrient, microbiological and physical quality for the ingredients 
and the HMF;
 4
 
 

 
details of quality control procedures 
respecting the
 
testing
 
of
 
the ingredients and the 
HMF;
 

 
details of the manufacturing 
process
 
and quality control procedures used throughout the 
process
; 
 

 
results of tests carried out to determine the expiration date of the HMF;
 

 
the evidence relied on to establish that the HMF is nutritionally adequate to promote 
acceptable growth and devel
opment in infants
 
when consumed in accordance with the 
directions of use
;  
 

 
the directions for use;
 

 
packaging and labelling information, including package inserts; and
 

 
the 
scientific rationale for the formulation.
 
 
In the assessment, the Minister of Health
 
would determine whether all of the required 
information has been submitted and the information provided is sufficient to establish that the 
HMF is safe. The Minister of Health would also be able to request in writing additional 
information relevant to the
 
application if it is required to assess the HMF
. 
When conducting a 
premarket review of a new HMF, the Minister of Health could also consider 
other 
relevant 
information
, such as information
 
provided to, or obtained from, a foreign regulator
 
or post
-
market 
data from another jurisdiction
. 
The Minister would notify the manufacturer in writing 
whether the sale or advertisement for sale of the HMF is authorized. Finally, the Minister would 
not authorize the sale or advertisement for sale of the HMF if there are 
reasonable grounds to 
believe that the information submitted is false, misleading or deceptive.
 
 
3.3.2 
HMFs that have undergone a major change
 
If a HMF undergoes a major change, the manufacturer would be required to make a pre
-
market 
submission with the required information. The HMF 
that has undergone a major change 
would 
only be permitted to be advertised for sale or sold once the submission is 
reviewed and assessed 
and the Minister of Health issues written 
authorization
 
to the manufacturer indicating that the 
HMF may be sold or advertised for sale
. 
 
 
The proposed amendments would set out submission requirements for the pre
-
market review of a 
maj
or change:
 

 
administrative information used to identify the HMF and the manufacturer;
 

 
a description of the major change;
 

 
the evidence relied upon 
to establish 
that the HMF is nutritionally adequate to promote 
acceptable growth and development in infants and
 
that the major change has no adverse 
effect on the HMF; 
 

 
written text of all labels, including package inserts; and
 

 
the 
rationale for the major change.
 5
 
 
 
The Minister of Health would assess that all the required information has been submitted, and is 
suffi
cient to establish that the HMF is safe.  The Minister of Health would also be able to request 
in writing additional information relevant to the application if it is required to assess the HMF.
 
Similar to new HMFs, for HMFs that have undergone a major chan
ge, 
the Minister of Health
 
could also consider 
other
 
relevant
 
information
,
 
such as information 
provided to, or obtained 
from, a foreign regulator
. 
The Minister would notify the manufacturer in writing whether the sale 
or advertisement for sale of the HMF that has undergone a major change is authorized. Finally, 
the Minister would not authorize the sale or advertisement for sale of the HMF if there ar
e 
reasonable grounds to believe that the information submitted is false, misleading or deceptive
.
 
 
3.3.3 
HMFs currently on the market
 
Manufacturers with HMFs that have previously undergone an assessment 
and 
received 
permission
 
from
 
Health Canada 
to sell in Canada 
will have one year to transition to the new 
regulatory framework.
 
Health Canada will publish a list of HMFs qualifying for this transition. 
 
 
Manufacturers of HMFs
 
on the list
 
would be required to submit an attestation that the HMF has 
not undergone a major change as well as proposed new label text
, including packaging inserts,
 
that complies with the new labelling requirements. Manufacturers would have one year from the 
coming 
into force date of the regulations to submit this information and receive 
written 
authorization
 
from the Minister. 
During that one
-
year period, manufacturers may sell the HMFs 
on the list in existing packaging. By the end of the one
-
year period
,
 
all 
necess
ary label changes 
must be made 
in order to come into compliance with 
the 
r
egulations
.
 
 
If after one year, manufacturers have not submitted this required information and received 
written authorization
 
from the Minister, they could not continue to sell or advertise for sale these 
HMFs in Canada. 
If m
anufacturers 
wish to receive authorization for these products after the one 
year transition period, they 
would need to 
submit an application
 
as a new HMF
 
pe
r draft 
provision
s
 
B.25.01
0
 
and B.25.01
1
. 
 
 
Further, should a manufacturer wish to apply for a major change for an HMF that has already 
undergone an assessment by Health Canada, it must first satisfy the above conditions, and then 
apply for a major change
.
 
 
To identify the HMF products that would be exempt from the full submission requirements, a list 
of HMFs that have been assessed by Health Canada entitled 
Human Milk Fortifiers Marketed in 
Canada as of March 31, 2021
 
would be published on the Government o
f Canada’s website and 
incorporated by reference into the Regulations. 
(Note, this is a placeholder date and will change 
to match the final coming into force of the regulations.)
 
 6
 
 
3.4 
Conditions related to the sale of HMFs
 
 
3.4.1 
Home use of HMFs
 
In Canada
, HMFs are currently only available 
for use 
in hospitals because of the specialised 
medical training required to manage the nutritional needs of certain preterm infants and other 
infants using HMFs as medically required. 
Health professionals in h
ospitals s
elect and 
administer HMFs based on the specific nutritional needs of each infant, monitor the requirements 
and regularly adjust the dosage based on the health status of the infant. 
 
 
While the administration of HMFs in a clinical setting is expected to rem
ain the primary way in 
which infants receive HMFs, 
emerging evidence and some experts
 
suggest that at home use 
for a 
limited time after discharge c
ould be beneficial 
for some infants
. Recent studies suggest that the 
use of HMFs post
-
discharge could improve
 
the growth trajectory of certain infants with ongoing 
medical conditions, provided there is sufficient oversight by a medical professional.
1
 
During
 
consultations, m
ost stakeholders agreed that a small subset of infants 
c
ould benefit from HMFs 
being availa
ble for post
-
discharge use. Estimates ranged from 5% 
-
 
30% of infants and were 
based on the stakeholders’ 
knowledge and judgement
.
 
 
On the other hand, health professionals have highlighted potential risks associated with improper 
administration or preparat
ion of the HMFs. Generally, there is a need to tailor the preparation of 
HMFs to the nutrient needs of the infant. HMFs are concentrated products, and administering 
more HMF than an infant requires could result in negative health impacts 
to the infant. As 
such, 
it is not appropriate for the general public to have access to HMFs without medical oversight.
 
 
In light of the potential benefits of at home use of HMFs, Health Canada is proposing to build 
flexibility into the regulations for the use of HMFs outsid
e of hospitals while maintaining the 
necessary level of medical oversight to help ensure their proper use by caregivers. The proposed 
amendments would allow for HMFs to be sold by hospitals, and permit the hospitals to provide 
HMFs to the general public fo
r home use with a written order by a physician. Manufacturers 
would not be allowed to
 
sell HMFs directly to the 
public. H
owever
, a hospital 
could
 
request that 
a manufacturer provide the HMF to 
an individual.
 
In this case, the request 
would have to
 
originate from the hospital to the manufacturer
 
and be
 
accompanied by 
a written order from a 
physician. 
Similar 
post
-
discharge programs have been in place in the U.S. for approximately a 
decade with no known issues.
 
  
 
Health Canada explored the feasibilit
y of broader access to HMFs, such as allowing nurse 
practitioners and/or registered dietitians to provide written orders for home use of HMFs or 
                                        
                  
 
1
 
Marino, LV, Fudge C., Pearson F, et al. Home use of breast milk fortifier to promote post
 
discharge growth and 
breast feeding in preterm infants: a quality improvement project. Archives of Disease in Childhood. Published 
Online First: 14 December 2018. doi: 10.1136/archdischild
-
2018
-
315951.
 7
 
 
permit the sale of HMFs through pharmacies. Nurse practitioners and registered dietitians are not 
licensed to w
rite orders in every jurisdiction. Given the niche market of HMFs, the absence of 
necessary supply chains outside of hospitals, and medical expertise required to oversee their safe 
use, broader distribution of HMFs with
in pharmacies is not recommended at t
his time. 
 
 
3.4.2 
Stop Sale 
 
Once an HMF is on the market, new information may become available that could influence the 
Minister of Health’s assessment of the HMF. In order to properly evaluate
 
the impact of that 
information, the Minister may require information from the manufacturer. In order to mitigate 
any potential harm from the use of HMFs, the proposed amendments include provisions where if 
a manufacturer is requested to submit information
 
by a specific date, they cannot make any 
further sales of that HMF product after that date unless the information is submitted. If the 
Minister does not think the information is sufficient, the Minister will notify the manufacturer 
who will then be requir
ed to stop selling the HMF until they provide sufficient information to the 
Minister
. 
These amendments 
are similar 
to
 
the provisions already in place for infant formulas. 
 
 
3.5 
Addition of vitamins, mineral nutrients and amino acids
 
 
The FDR regulates the addition of vitamins, mineral nutrients and amino acids to foods to help 
ensure that Canadians receive sufficient but not excessive amounts of these nutrients in their diet. 
The FDR prohibits the addition of vitamins, mineral nutrient
s and amino acids to foods 
unless 
otherwise permitted in the FDR
.
 
 
The proposed amendments would enable the addition of 
certain 
vitamins, mineral nutrients, and 
amino acids to HMFs, with no prescribed maximum or minimum levels. The levels of nutrients 
adde
d to 
a HMF 
would be reviewed and assessed on a case
-
by
-
case basis to help ensure its safety 
and nutritional adequacy. By not setting maximum and minimum levels in the regulations, it 
would allow for flexibility in the nutritional composition of HMFs
 
and
 
permit more specialized 
product development. The nutrient requirements of infants
 
wh
o
 
require HMFs
 
are highly 
variable
 
and hospitals regularly adjust 
the 
use of HMFs based on the individual needs of each 
infant. Including specific compositional requiremen
ts for HMFs could limit product formulations 
that could benefit this vulnerable population.
 
 
Choline is an essential nutrient which has been 
permitted to be 
added 
under the FDR 
to
 
infant 
formula
. 
Recently, choline was reclassified as a vitamin under the FD
R and as such, became 
subject to the re
strictions 
applicable to
 
the addition 
ds
. The proposed amendments would 
explicitly permit 
the addition of 
choline 
as a vitamin 
to HMFs, infant formula and formulated 
liquid diets. 
 
 
3.6 
Food additives 
 8
 
 
 
A food additive typically is a chemical substance that is added to food during manufacture that 
either becomes a part of the food or affects its characteristics for the purpose of achieving a 
particular technical effect. A food that contains a food additiv
e can only be sold in Canada if the 
use of the food additive in the food is permitted in Health Canada’s Lists of Permitted Food 
Additives which are published on the Government of Canada’s website.
2
 
The Lists are generally 
organized according to the techni
cal purpose for which the additives on each List may be used 
(e.g. List of Permitted Preservatives; List of Permitted Emulsifying, Gelling, Stabilizing or 
Thickening Agents). 
 
 
Some HMFs that have been allowed to be available in Canada contain one or more 
food 
additives. Health Canada assessed these uses of food additives as safe and intends to permit them 
more generally in HMFs by adding the uses to the applicable Lists of Permitted Food Additives. 
Health Canada plans to modify the Lists concurrently with 
the proposed regulatory amendments 
for HMFs that are the subject of the present policy paper. 
The public and other stakeholders will 
be informed of the specific uses of food additives permitted for HMFs through the publication of 
a Notice of Modification 
which is anticipated for Fall 2020/Winter 2021
. 
 
 
Also concurrent with the proposed regulatory amendments for HMFs, Health Canada intends to 
amend two of the food additive Marketing Authorizations
, the 
Marketing Authorization For 
Food Additives That May Be
 
Used As Food Enzymes
 
and the 
Marketing Authorization For Food 
Additives That May Be Used As Preservatives
. This is being proposed 
so that in the future the 
Department will be able to permit certain new food additive uses for HMFs or other infant foods, 
if
 
requested, using the usual authorization process for food additives, which is to add the new use 
to the List of Permitted Food Additives that is incorporated by reference into the MA. 
 
 
Anyone wishing to request that Health Canada permit uses of food addi
tives in HMFs not 
permitted by the List modifications referred to above can do so through the usual food additive 
submission premarket review process.
3
  
 
 
Another amendment related to food additives is also proposed to subsection B.25.062(1) to 
replace the
 
phrase “a food that is labelled or advertised for consumption by infants” with “infant 
food” to simplify and modernize the language.
 
 
3.7 
Labelling requirements
 
                                        
                  
 
2
 
There are 15 Lists of Permitted Food Additives, each
 
of which is incorporated by reference to a marketing 
authorization 
-
 
https://www.canada.ca/en/health
-
canada/services/food
-
nutrition/food
-
safety/food
-
additives/lists
-
permitted.html.
 
3
 
See the website Food Additives 
–
 
Submission Preparation (https://www.can
ada.ca/en/health
-
canada/services/food
-
nutrition/food
-
safety/food
-
additives/food
-
additives
-
submission
-
preparation.html)
 9
 
 
 
There are standard labelling requirements that apply in general to prepackaged foods, such as
 
requirements for nutrition information labelling, ingredient labelling, nutrition related claims 
(e.g. nutrient content claims), date markings and lot numbers. Health Canada is proposing 
amendments to adapt these requirements to HMFs as well as to introdu
ce a requirement for 
directions for preparation, storage and use and a cautionary statement to only use HMFs under 
medical supervision. 
 
 
3.7.1 
Nutrition labelling
 
Health Canada is proposing to prohibit 
use of 
a Nutrition Facts table (NFt)
 
for HMFs
. The Daily 
Values (DVs) used in the NFt for foods intended solely for infants and/or children are based on 
nutrient requirements for infants six months or older but less than one year, or for children one 
year of age or older but less than four years of a
ge, respectively. HMFs are used by populations 
less than six months of age. Therefore, it is not appropriate to apply DVs which are based on the 
dietary requirements for the general population of infants and children in the respective age 
group in this cir
cumstance. Accordingly, HMFs would be added to the existing provisions 
prohibiting certain foods from carrying an NFt.
 
 
Health Canada is proposing to require the labelling of HMFs to include a modified table of 
nutrition information that sets out the energy value in calories and the amount of key nutrients 
per stated quantity of the HMF that is indicated in the directions f
or use. 
The key nutrients that 
must be included on the label are 
protein, fat, available carbohydrate, fibre, vitamins (including 
choline), mineral nutrients, amino acids, and any other nutritive substance present in the HMF
.
 
More specific information abou
t t
he nutrients that must be declared on the label, along with their 
units, would be specified in the FDR. The units of measurement would differ slightly for some 
nutrients from those required for other foods as they may correspond to smaller amounts of a 
particular nutrient (e.g. milligrams or micrograms versus grams). 
It is not anticipated that these 
requirements will result in significant labelling changes for HMFs as the
se requirements 
generally 
aligned with how HMF are currently labelled. 
 
3.7.2 
Ingred
ient labelling
 
Health Canada is proposing amendments that would allow most of the existing requirements for 
ingredient labelling (e.g. font size and case, spacing, colour, legibility, borders, etc.) to apply to 
HMFs. However, HMFs would be exempt from the 
requirement to group types of sugars 
together in the list of ingredients. Types of sugars 
for regular foods have to be 
grouped together 
in the ingredient list so that consumers can easily identify all the sugars added to a food, helping 
consumers make info
rmed and healthier choices. However, HMFs are to be used under medical 
supervision and consumers do not make choices on the type of HMF used. Therefore, grouping 
of sugars would be less useful for medical professionals who are responsible for the selection
 
and administration of HMFs which are based on the infant’s medical 
or nutritional 
needs. 
 10
 
 
 
3.7.3 
Nutrition related claims
 
Health Canada is proposing the following amendments related to claims:
 

 
HMFs containing hydrolyzed or partially hydrolyzed casein, collagen or gelatin (protein 
sources) would not be required to carry a caution statement to “not use as a sole source of 
nutrition” (currently a requirement for other foods containing these ingredi
ents). This 
caution statement would be redundant, and could cause confusion, as HMFs are never to 
be used as a sole source of nutrition; 
 

 
HMFs would be permitted to include a representation on their label that they are a food 
that is consumed by an infant 
less than six months of age;
 
 

 
No claims relating to the percentage of 
the 
Daily Value 
for certain nutrients (fat, 
saturated or trans fatty acids, sodium, potassium, carbohydrate, fibre or cholesterol) 
or the 
number of Calories 
from fat or saturated or tran
s fatty acids 
would be permitted to appear 
on the label or in any advertisement for HMFs (e.g. “no sugar added”, “source of fiber”)
; 
and
 

 
No claims claim set out in column 4 of the table following section B.01.513
 
of the FDR 
are permitted (e.g. “excellent s
ource of protein”, “energy free”).
 
 
 
3.7.4 
Directions, date markings and lot numbers
 
The proposed provisions would include requirements for directions on the label for the storage of 
the HMF before and after it has been opened, and directions for the prepa
ration, use and storage 
of the HMF after it has been mixed with human milk. A
 
statement identifying the HMF is to be 
used only under medical supervision 
would also be required
 
on the outer label
.
 
 
HMFs would 
be required to include
 
an expiration date
 
and a 
lot number
 
on the outer label
.
 
HMFs 
are often sold or packaged as multiple units or sachets. As a result, the proposed amendments 
would also require the labelling of the expiration date and lot number to apply to inner labels. 
The expiration date would be 
permitted to be on the bottom of a package, similar to other foods 
for special dietary use
 
and infant formula
.
 
 
3.8 
Coming into Force
 
 
The proposed amendments would come into force upon publication in the 
Canada Gazette
, Part 
II, with the exception of labe
lling changes related to HMFs already on the market in Canada, 
which would have a one
-
year period to become compliant with the regulations. 
 
 
3.9 
Service standards
 
 11
 
 
Health Canada is committed to improving the timeliness of application reviews for HMFs.
 
Once 
a complete submission package is received, Health Canada would apply a service standard of 90 
days of active review time for the vast majority of HMFs. This is similar to the review times 
currently required for HMFs in the US. 
 
 
The service standards 
will be provided in a Health Canada guidance document published at the 
same time as the final regulations.
 
As well, g
uidance documents will be developed 
for preparing 
applications for premarket assessment, good manufacturing processes, information required
 
for 
new manufacturing facilities, clinical trials for preterm infants and evidence required to establish 
nutritional adequacy of a HMF
.