1. No category

IFRA-IOFI LABELLING MANUAL 2013
FOR THE HAZARD CLASSIFICATION AND LABELLING OF FLAVOUR AND
FRAGRANCE SUBSTANCES ACCORDING TO THE UN GHS, UN TDG and EU
DSD.
IMPORTANT DISCLAIMER:
1. The IFRA/IOFI Labelling Manual has been carefully prepared by the IFRA/IOFI Secretariats and the
IFRA/IOFI GHS TF. The guidelines or recommendations provided by IFRA/IOFI should not be
considered or used as a substitute for legal advice.
2. The guidance provided by IFRA/IOFI does not relieve member associations or their members of
their obligations under applicable national and regional laws and regulations.
3. While appropriate efforts have been made to insure the accuracy of this document, IFRA/IOFI
cannot be held liable for errors or omissions in this document. Member associations and their
members should always satisfy themselves in any particular instance that the suggestions made by
IFRA/IOFI can be properly followed.
4. Neither IFRA/IOFI nor any individual members or officers, can be held liable for any loss or damage
suffered by any member association or its (individual) members as a result of following or relying on
the IFRA/IOFI Labelling Manual.
BY USING THIS LABELLING MANUAL, YOU WILL BE DEEMED TO HAVE UNDERSTOOD AND
ACCEPTED THE CONDITIONS OF THIS DISCLAIMER.
Important information in regards to the release of the Labelling Manual 2013 (in the following
abbreviated as LM):
During 2013 r ca 250 materials have been reviewed. Compared to the 2012 LM the number of
substances in Att I has increased from 1522 up to 1597.
From the above mentioned number of substances ca 200 substances registered under REACH in
2013 have been reviewed to update the LM accordingly. In some cases expert judgement has been
used for the interpretation of some registration dossiers submitted. For example in case of
intermediate dossiers (data poor) or where classifications were assigned not in accordance with data
given. This is indicated by a separate footnote 12.
NCS Att IV and V have been expanded with some 30 NCSs substances with VoU > 1 t. The number of
entries has increased from 339 to 366. For some products originating from same family of species the
CAS/EINECS numbers could be combined as compositional data were equivalent.
Some chemically modified NCSs have been moved to Att I (chemical section); relevant compositions
are given, similar NCSs, in Att V.
In Att IV the footnotes have been separated from the names and are given in a separate column. Also
a Flashpoint which is considered typical for the NCS is now mentioned. It speaks for itself, especially
in the band around the classification limits, that the actual value for flammability determination
(GHS/transport) shall be used.
Last year some materials were no longer maintained and were only mentioned in Att VI- Functionals.
Based on feedback received and as some are used as flavour and fragrance ingredient it was
concluded that some of these materials ought to come back in Att I, II, and III.
- 2 of these materials were deleted as they were no longer reported in the recent global Volume of Use
surveys.
84-74-2
Dibutyl phthalate
123-31-9
Hydroquinone
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- Where route of exposure and/or target organs were missing in case STO endpoints this info has
been added as far as available.
Access to disseminated REACH registration dossiers can be found by using the following link:
http://apps.echa.europa.eu/registered/registered-sub.aspx
Quality improvement of the LM is an ongoing activity and we welcome any comment on content or layout; please send your observations/remarks to [email protected].
A. GENERAL CONSIDERATIONS
The IFRA/IOFI GHS Task Force, with global representation, including Brazil, Europe, the United
States and Japan, will classify fragrance and flavour materials following the criteria laid out in the UN
GHS guidance document, which is currently the 5th revised edition (the so-called “Purple Book”, which
can be downloaded: http://www.unece.org/trans/danger/publi/ghs/ghs_rev05/05files_e.html
It will also assign UN Transport classifications as well as EU DSD classifications, as long as those
remain active. EU DSD classifications will be maintained until end of 2014 for LM 2014 and will
be deleted with the next LM issue 2015.
The Task Force takes into account the physical/chemical, toxicological and eco-toxicological data
available for these substances at the time of the publication of this Labelling Manual. Substances that
are to be classified as hazardous as well as those which are not classifiable based on current
knowledge, are included in the attached lists.
Decisions on how to deal with issues in the area of hazard assessment are documented in a Modus
Operandi (MO) justifying the contents of the work product of the group (Labelling Manual and Flavour
or Fragrance Ingredient Data Sheets (FFIDSs)). This document will serve as a means to ensure an
identical approach within the Fragrance and Flavour Industry during the process and to serve as a
reference of supplementary convention and expert interpretation for fragrance and flavour raw
materials. The benefit of this activity is to provide a single global classification of all flavour and
fragrance materials to avoid regional differences as the GHS standards are rolled out globally over
time.
Please note that the MO is currently under revision.
B. USE OF THE IFRA/IOFI LABELLING MANUAL
The information provided in this Labelling Manual is intended to provide direction to companies to
assure a consistent hazard classification and labelling for fragrances and flavours and their
ingredients. It must be stressed that:
 Any official regional classification of substances prevails over self-classification of the GHS
Task Force.
 The Attachments to this Manual are not comprehensive and the absence of a substance or a
specific classification should not be taken to imply that no classification and/or labelling are
required.
 In order to make the Attachments as comprehensive as possible, the GHS Task Force
welcomes for consideration, any proposal for additions or amendments on the basis of the
voluntary shared knowledge within the Flavour and Fragrance Industry.
 The substances examined have been considered for their flammability. Results using the
Pensky Martin Closed Cup (PMCC) method were taken as the reference. Due to the variability
of flash point determinations (e.g. influenced by minor impurities and variations in the
compositions of oils), actual measured flash points are the responsibility of the member
companies. Member companies should not rely on the recommendation as contained in the
Manual, but rather rely on their own data.
 The listing of a substance in one of the Attachments does not mean an approval for use in
fragrances or flavours. Indeed, some of the substances may be subject to restrictions for
specific applications, such as the IFRA Standards, EU Cosmetic Legislation, flavour
regulations, etc. The implementation of a new or an amended classification or labelling should
be initiated after publication of the updated Labelling Manual (see section C).
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
For some of the substances, individual limit concentrations have been officially assigned in
Annex VI of the CLP Regulation (EU DSD). They are mentioned in the Attachments and have
to be followed instead of the general so-called administrative limit concentrations when
classifying a preparation according to the conventional method of the EU DPD or CLP
respectively.
Each supplier is reminded that they bear the final responsibility for the appropriate classification and
labelling of the products they place on the market, based on the quantity and composition of their
product.
a) Aspiration hazard (UN GHS: AH Cat1; EU DSD: Xn; R65)
Some substances and preparations pose a specific hazard upon ingestion since they can be aspirated
into lungs and cause lung damage. The criteria for classification are purely of a physicochemical
nature (hydrocarbons or preparations [mixtures] containing >10% hydrocarbons with a kinematic
viscosity and/or surface tension below a given value).
Based on measured results for a number of Natural Complex Substances (NCS) with hydrocarbon
contents between 10 and 90+ %, and on similar measurements of some flavour and fragrance
compounds, the Task Force has come to the conclusion that in practice, substances and preparations
containing more than 10% of hydrocarbon(s) fall within the criteria for viscosity and/or surface tension,
unless the material is a solid or reported to be a viscous liquid.
In the absence of data for a specific NCS and based on the above, it is recommended:
- to determine the hydrocarbon content of substances (supplier information, analysis) and preparations
(calculation) and to classify as AH Cat 1 and Xn; R65 respectively if more than 10%
Hydrocarbons are present;
- non-classification should only be possible if viscosity measurement results [and/or surface
tension measurements (EU DSD)] are available for a specific, not obviously viscous substance
preparation.
b) Classification of Natural Complex Substances (NCS)
NCS (Essential oils and volatile solvent extracts) used in perfume compounds and flavours are known
to have variable composition. This variability is well defined by ISO norms and /or by industry
statistics. The bridging principle approach, as defined by GHS, CLP and EU DPD, must be utilised to
assess the impact of this variability on the classification. If robust test data are available, a specific
quality of a NCS must be classified on the basis of the result as indicated in GHS (cf. 1.3.2.3).
This classification, however, is only applicable to the material and thus, its composition tested and
other NCSs where the chemical composition has been demonstrated to be equivalent.
For other grades of NCS’s, and for endpoints for which reliable test data are lacking, the UN GHS
guidance document, as well as the EU DSD regulations, incorporate requirements whereby the hazard
classification of complex substances shall be evaluated on the basis of levels of their known chemical
constituents. Where knowledge about hazardous constituents exists, e.g. on substances with
sensitizing, toxic, harmful, corrosive, environmentally hazardous properties, the classification and
subsequent labelling of these NCSs should follow the additivity rules for mixtures (GHS) and
conventional method (EU CLP/DPD) respectively.
Guidance for the typical abundance of the hazardous constituents occurring in the NCSs is provided in
Attachment V. These values are a result of the shared knowledge of the Industry at the time of the
publication of this LM.
The hazard classifications based on these values, derived following the approaches indicated above,
are located in Attachment IV of this Manual. Uncertainty may exist over whether any particular quality
of a NCS corresponds to the quality on which the tests and/or calculations were carried out.
Attachment V, footnote 3 a-d, covers cases where the classification was obtained by reliable test data
for a particular endpoint, as opposed to calculation.
c) Classification of Fragrance and Flavour compounds containing Natural Complex
Substances (NCS)
Flavour and Fragrance compounds are mixtures according to the UN GHS guidance document. In
practice, test data on the flavour or fragrance compounds are often not available or collected.
Therefore, the classification of these products should be based on the chemical composition and
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should include the contributions of hazardous substances present as constituents in the NCSs present
in the formulation. Available robust test data on specific NCS’s should take precedence.
This implies that the hazardous substances present in a NCS should be known and it is recommended
to request that this information be included in the Safety Data Sheet of that NCS (section 3:
Composition/information on ingredients, according to the UN GHS guidance document). In case of
absence of this information, Attachment V can be used.
However, it should be realized that when a NCS is mentioned in an official inventory (e.g. Annex VI of
the European CLP regulation) this classification must be used and not the classification resulting from
the constituents.
d) Transport classification
The assignment of UN numbers, packing group and hazard class is based on the criteria as laid down
in the Recommendations on the Transport of Dangerous Goods Model regulations as
published by the United Nations, 17th edition (so-called Orange Book ST/SG/AC.10/1/Rev.17). The
assigned UN-number is a recommendation, which should be used to verify detailed differences
between the various modes of transport, such as: air, sea and land (land transport can be separated
into road, rail and in-land water ways).
Where needed, the EU hazard classification of the substance is supplemented with the ADR-rules,
including the links to the EU-DSD and DPD.
Also, for transport, due account should be given to any national deviations from the rules applied here.
C. IMPLEMENTATION AND OTHER INFORMATION
The time for implementing new or modified classifications with regard to, UN Transport and EU DSD
regulations as indicated in attachments I to VI, as approved by the GHS Task Force should not exceed
a period of six months following the publication of the Labelling Manual. Other regional requirements
must be observed.
Regarding the implementation of GHS classifications it is up to the individual companies to decide at
what time - and depending on the respective regulations in the country or region considered – these
shall be applied.
Please note that the legal requirements regarding compliance dates of any new officially classified
substances prevail over the above mentioned six months period as agreed by our industry.
The GHS Task Force adds the following clarification regarding compliance:
 New or modified classifications apply to the substances defined by the indicated Chemical
Abstracts Service Registry numbers (CAS numbers) regardless of whether alternative CAS
numbers exist.
 New additions to the lists are marked with “ + “
 Corrections and modifications are indicated with “ x “
 For those substances, for which classification and labelling was not considered necessary
“Not Classified”, based on the data available to the Group and the shared knowledge of the
flavour and fragrance industry brought to their attention, be aware that classification might
arise when considering the presence of classified constituents, as outlined above.
UN GHS
Following the UN GHS guidance document, the GHS Task Force applies the criteria for all hazard
classes and categories (except for some physico-chemical hazards not encountered in F&F
ingredients, see Appendix 1) as mentioned in the so-called “Purple Book” aiming at harmonized UN
GHS classifications of substances. The results comprise the indication of Flash Point and Acute
Toxicity Estimate (ATE). Further M-factor of 1 has to be considered for the Environmental Hazard
categories A1/C1 unless otherwise indicated. The labelling elements (Pictogram, Signal Word, Hazard
statements, Precautionary statements) that have to be used for a given hazard classification are
spelled out in Annexes 1, 2 and 3 to the UN GHS.
The table of UN GHS hazard classifications for chemically defined substances can be found in
attachment I of the LM. Please note that this table includes substances which have been identified by
the group of having L (E) C50 values of less than or equal to 0.1mg/l and larger than 0.01mg/l for
acute aquatic toxicity. Following UN GHS for these substances M-factors of 10 have been assigned.
UN TDG:
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The assignment of UN numbers, packing group and hazard class is based on the criteria as laid
down in the Recommendations on the Transport of Dangerous Goods Model regulations as published
by the United Nations 17th edition (so-called “Orange Book”). The assigned UN-number is a
recommendation that should be used to verify detailed differences between the various modes of
transport, such as: air, sea and land (land transport can be separated into road, rail and in-land water
ways). Also, for transport, consideration should be given to any national deviations from the rules
applied here.
The table of UN Transport classifications for chemically defined substances can be found in
attachment III of the LM.
EU DSD:
The classification and labelling of substances is either prescribed in Annex VI to the CLP Regulation
(EC) No 1272/2008, or has to be done by the supplier using the criteria of Annex VI of the Dangerous
Substances Directive 67/548/EEC (EU DSD). For preparations, like flavour and fragrance compounds,
the rules of the Dangerous Preparations Directive 1999/45/EC (EU DPD) have to be followed.
Although the CLP regulation has entered into force on 20 January 2009 - which has introduced the
GHS into the European Union - a staggered approach for that implementation has been foreseen.
During the transition periods, ending on 1 June 2015, the indication of the classification following the
DSD and DPD Directives is still mandatory in the respective Safety Data Sheets.
Note that Annex I to the DSD and its adaptations to technical progress have been transferred to the
CLP Regulation EC (No) 1272/2008, Annex VI; the Annex I to the DSD has been repealed. Several
substances of interest to the fragrance and flavour industry with their official classifications are
mentioned in Annex VI to the CLP Regulation. They are included in the respective attachments to this
Labelling Manual with their Annex number next to their CAS and EU number.
The table of EU DSD hazard classifications for chemically defined substances can be found in
attachment III of the LM. Please note that this table includes substances which have been identified by
the group of having L(E)C50 values of less than or equal to 0.1mg/l and larger than 0.01mg/l for acute
aquatic toxicity. Following Directive 2006/8/EC for these substances specific concentration limits are
applied.
EU CLP:
The difference in classification between UN-GHS and EU-CLP is caused by the difference of
implementation of the building blocks.In Appendix II the difference in building blocks between the two
classification schemes is given.
For the blue coloured fields the schemes are identical, the yellow colour indicates a difference.
To derive from UN-GHS to EU-CLP is the substraction of the EU-non applicable building blocks from
UN-GHS classification.
For example a substance with ATO 5(3700),FL 4,SCI 3, will become “Not classified” under EU-CLP.
Natural Complex Substances:
a) Classifications provided in this annex are examples only provided as guidance based on available
data and representative constituent information only. They do not represent appropriate classifications
for all qualities of an NCS as these may vary substantially. It is incumbent on the supplier and/or
manufacturer to ensure their NCS is appropriately classified based on test data or on constituent
information for their supplied material.
IFRA/IOFI does not warrant the accuracy of this information that is provided only to help companies
identify possible classification considerations for their materials. The table of UN TDG, EU DSD and
UN GHS hazard classifications/hazard statements for Natural Complex Substances (NCS) can be
found in attachment IV of the LM.
b) As explained in sections b) and c), in the case of absence of information about actual levels of
hazardous substances present in natural complex substances, this list should be taken into account
for the hazard classification of NCS and for their contributions to the hazard classification of flavour
and fragrance compounds. NCS constituent information provided in this annex are examples only
provided as guidance based on representative constituent information only. They do not represent
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constituent composition for all qualities of an NCS as these may vary substantially. It is incumbent on
the supplier and/or manufacturer to ensure their NCS is appropriately classified based on test data or
on constituent information for their supplied material. IFRA/IOFI does not warrant the accuracy of this
information that is provided only to help companies identify possible classification considerations for
their materials.
The table on the potential presence of hazardous constituents in natural complex
substances (NCS), containing percentage information, UN GHS and EU DSD classification
can be found in attachment V of the LM.
Functional components:
The IFRA/IOFI GHS TF decided to no longer maintain in the LM those ingredients that are not typical
flavour or fragrance materials, but are considered to be “functional ingredients, e.g., solvents.
The materials from the LM2010 that will no longer be maintained and therefore, will drop out of the LM
in the following editions can be found in attachment VI of the LM.
Appendix I
Overview of GHS hazard classes considered and the abbreviations used.
Appendix II
Overview of UN-GHS and EU-CLP building blocks
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Appendix 1:
GHS Hazard classes and its related abbreviations.
The table below reflects the 4 physical, 11 health and 1 environmental hazard classes as well as
their abbreviations that have been considered for classification.
Flammable gas
GHS Class
abbreviation
FG
Pressurised gas
PG
Flammable liquid
FL
1,2,3,4
Flammable solid
FS
1,2
Acute toxicity, oral
ATO
1,2,3,4,5
Acute toxicity, dermal
ATD
1,2,3,4,5
Acute toxicity, inhalation
ATI
1,2,3,4,5
Skin corrosion/irritation
1A,1B,1C,2,3
Serious eye damage/eye irritation
SCI
EDI
Respiratory sensitization
RS
1
Skin sensitization
SS
1, 1A,1B
Germ cell mutagenicity
MUT
1A,1B,2
Carcinogenicty
CAR
1A,1B,2
Reproductive Toxicity
Specific Target Organ toxicity – Single
exposure
Specific Target Organ toxicity – Single
exposure
REP
1A,1B,2
STO-SE
1, 2
GHS Hazard Class
Specific Target Organ toxicity – Single
exposure
STO-SE (NE)
STO-SE (RI)
Specific Target Organ toxicity – Repeated
STO-RE
exposure
Aspiration hazard
AH
Hazardous to aquatic environment
Repeated exposure may cause skin
dryness or cracking.
Corrosive to the respiratory tract.
EH
GHS Hazard Categories
1,2A,2B
3 (Transient target organ
effects: narcotic effects)
3 (Transient target organ
effects: respiratory tract
irritation)
1, 2
1, 2
A1,A2,A3,C1,C2,C3,C4
EUH 66
EUH 71
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Appendix II
Difference of building blocks between UN-GHS and EU-CLP.
GHS Hazard Class
GHS Class
Abbreviation
GHS Hazard Categories
EU
Flammable liquid
FL
1,2,3,4
1,2,3
Flammable solid
FS
1,2
1,2
Acute toxicity, oral
ATO
1,2,3,4,5
1,2,3,4
Acute toxicity, dermal
Acute toxicity, inhalation
Skin corrosion/irritation
ATD
ATI
SCI
1,2,3,4,5
1,2,3,4,5
1A,1B,1C,2,3
1,2,3,4
1,2,3,4
1A,1B,1C,2
Serious eye damage/eye irritation
EDI
1,2A,2B
Respiratory sensitization
RS
1(A,B)
1,2
1(A,B)
Skin sensitization
SS
1(A,B)
1(A,B)
Germ cell mutagenicity
MUT
1A,1B,2
1A,1B,2
Carcinogenicty
CAR
1A,1B,2
1A,1B,2
Reproductive Toxicity
Reprotox: Effects on or via
lactation
Specific Target Organ systemic
toxicity - Single exposure
REP
1A,1B,2
1A,1B,2
yes
yes
1, 2
1, 2
STO-SE
Specific Target Organ systemic
toxicity - Single exposure
STO-SE
3 (Transient target organ
effects: narcotic effects)
3 (Transient target organ
effects: respiratory tract
irritation)
Specific Target Organ systemic
toxicity - Single exposure
STO-SE
Specific Target Organ systemic
toxicity - Repeated exposure
STO-RE
1, 2
1, 2
Aspiration hazard
AH
1, 2
Acute aquatic toxicity
EH
A1,A2,A3
1
A1
Chronic aquatic toxicity
EH
C1,C2,C3,C4
C1,C2,C3,C4
3-NE
3-RI
Legend: blue=identical; yellow=different.
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