Professional Documents
Culture Documents
What is IFRA?
The International Fragrance Association (IFRA), founded in 1973, represents the interests and is the voice of the
fragrance industry worldwide. It promotes the safety and benefits of the fragrance industrys products through
stakeholder dialogue on a global basis.
Membership in IFRA is open to (1) national and regional fragrance associations from across the world representing
members of the local fragrance industry, (2) companies with global operations engaged primarily in the formulation
of fragrance compounds, as well as (3) companies that manufacture, formulate, market, or distribute fragrance
ingredients, and/or fragrance compounds, (which can be members of IFRAs national and regional associations, or
in their absence, directly of IFRA as supporting members), hereafter collectively referred to as IFRA members.
IFRA is represented on all continents. A current list of IFRA members as well as additional information on IFRA, IFRA
membership criteria, IFRA Committees and Bylaws can be found on the IFRA website (www.ifraorg.org).
Fragrance ingredients and fragrance compounds are subject to international regulatory regimes worldwide which
may be different depending upon their use and the countries/regions in which they are manufactured, formulated,
used and marketed. It is the responsibility of each IFRA member to ensure that the fragrance compounds or
ingredients they supply comply with applicable laws and are safe for their intended uses.
When warranted by concerns regarding the safe use of a specific ingredient, IFRA will issue an IFRA Standard.
IFRA Standards can either prohibit, restrict or set purity requirements for specific ingredients. Not all fragrance
ingredients are subject to IFRA Standards.
The safety of ingredients, whether the subject of an IFRA Standard or not, remains the responsibility of IFRA
members. Compliance with IFRA Standards is therefore necessary for compliance with the IFRA Code, but may
not be sufficient to ensure regulatory compliance and the safety of fragrance compounds or ingredients.
It is the responsibility of individual companies and their employees, with the support of IFRA and its member
associations, to determine how to apply the IFRA Standards, in accordance with applicable law and other
requirements of the countries in which they operate.
IFRA Standards are prepared by the IFRA Scientific Committee and IFRA on the basis of the decisions made by
REXPAN (The RIFM Expert Panel)*. The adoption of IFRA Standards includes a consultation phase of 3 6
months involving IFRA members, customer associations and other interested stakeholders. If any additional
information is generated that might alter the Standards, a new REXPAN review and decision is required.
The IFRA Standards and related documents are subject to regular changes as new information relevant to the
safety of fragrance ingredients become available. They can be downloaded from the IFRA website or obtained from
IFRA upon request. When IFRA members have evidence that warrants the issuance or modification of a Standard,
they shall inform IFRA.
IFRA members must comply with IFRA Standards. An IFRA member is deemed in violation of this Code when it
supplies a fragrance ingredient or fragrance compound that is, or contains, an ingredient used in violation of an
IFRA Standard.
IFRA Standards and other recommendations are developed in good faith from the most recent scientific opinions
and collective experiences of various committees and working groups within and outside IFRA. As such, neither
IFRA nor any of its officers or directors shall be liable for their accuracy and completeness, nor for actions taken in
applying them under any circumstance.
IFRA members shall also follow good operating practices when producing fragrance compounds and fragrance
ingredients.
Notes:
* The Research Institute for Fragrance Materials (RIFM) is a non-profit scientific institute founded by the Fragrance
Industry in 1966 for the purpose of generating and evaluating safety data on fragrance ingredients. The scientific
foundation of RIFM is built around its independent Expert Panel (REXPAN). It is comprised of internationally known
academic dermatologists, pathologists, toxicologists and environmental scientists.
IFRA OPERATIONS
Avenue des Arts 6 Tel.: ++ 32 2 214 20 60
B 1210 Brussels Fax: ++ 32 2 214 20 69
IFRA MEMBERS
Regular Members
GIVAUDAN SA (Corporate)
5, Chemin de la Parfumerie Tel.: ++ 41 22 780 91 11
CH 1214Vernier Fax: ++ 41 22 780 91 50
Switzerland URL : www.givaudan.com
Ifra operations Ifra Headquarters
Avenue des Arts, 6 1210 Brussels Belgium Rue du March, 9 1204 Geneva, Switzerland
T +32 (0)2 214 20 60 F +32 (0)2 214 20 69
Ifraorg.org
INTERNATIONAL FLAVORS & FRAGRANCES, INC. (I.F.F.) Global Headquarters
521 West 57th Street Tel.: ++ 1 212 765 5500
New York, NY 10019 Fax: ++ 1 212 708 7132
United States URL: www.iff.com
Association Members
ARGENTINA
CAFEPA Cmara Argentina de fabricantes de Productos Aromticos
Defensa 251 Tel.: ++ 54 11 4331 9866
4 Piso, Oficina 19 (1093) Fax: ++ 54 11 4331 9866
AR - 1010 Buenos Aires E-mail: cafepa@speedy.com.ar
Argentina URL: www.cafepa.com.ar
BRAZIL
ABIFRA Associao Brasileira das Industrias de Oleos Essenciais, Produtos Quimicos Aromaticos,
Fragrncias, Aromas e Afins
Av. Brigadeiro Faria Lima 1903, cj72 Tel.: ++ 55 11 2924 6705
01452-912 So Paulo - SP Fax: ++ 55 11 3813 5431
Brazil E-mail: abifra@abifra.org.br
URL: www.abifra.org.br
COLOMBIA
ANDI Asociacin Nacional de Empresarios de Colombia - Cmara Industria de Sabores y Fragancias
Calle 73 No 8-13 Torre A Piso 8 Tel.: ++ 57 1 326 8500 Ext. 2208
CO Bogot Fax: ++ 57 1 347 3198
Colombia E-mail: cboffuzzi@andi.com.co
URL: www.andi.com.co
FRANCE
PRODAROM Syndicat National des Fabricants de Produits Aromatiques
Avenue Riou Blanquet 48 Tel.: ++ 33 4 92 42 34 80
BP 21017 Fax: ++ 33 4 92 42 34 85
FR - 06131 Grasse Cedex E-mail: info@prodarom.fr
France URL www.prodarom.fr
GERMANY
DVRH Deutscher Verband der Riechstoff-Hersteller e.V.
Office in Germany:
Wacholderstrasse 1
DE - 53340 Meckenheim
Germany
Office in Brussels:
Boulevard Charlemagne, 96 Tel.: ++ 32 2 234 37 37
BE - 1000 Brussels Fax: ++ 32 2 234 37 39
Belgium E-mail: info@dvai-dvrh.eu
URL www.riechstoffverband.de
INDONESIA
AFFI Asosiasi Flavor dan Fragran Indonesia (Indonesia Flavors and Fragrances Association)
Menara Anugrah 9th Floor, Tel.: ++ 62 21 299 55 700
Kantor Taman E.3.3 Fax: ++ 62 21 299 55 788
Jl. Mega Kuningan Lot 8.6-8.7 E-mail: hazemi@indo.net.id
Kawasan Mega Kuningan URL: www.affi.or.id
Jakarta Selatan
JAPAN
JFFMA Japan Flavor and Fragrance Materials Association
Sankei-Nihonbashi Bldg 6F Tel.: ++ 81 3 3516 1600
4-7-1, Honcho Nihonbashi Chuo-ku Fax: ++ 81 3 3516 1602
JP Tokyo 103-0023 E-mail: jffma@nifty.com
Japan URL: www.jffma-jp.org
KOREA
KFFA - Korea Flavor & Fragrance Association
701-7 Banpo-Dong Tel.: ++ 82 (2) 514 3585
Seocho-Ku Fax: ++ 82 (2) 540-4516
Seoul 137-808 E-mail: castanea38@nate.com
Korea URL: www.kffa-kr.or.kr
MEXICO
ANFPA Asociacin Nacional de Fabricantes de Productos Aromticos, A.C.
Descartes No. 54- piso 5 D-502 Tel.: ++ 52 (55) 525 47636
Col. Nueva Anzures Delg. Miguel Hidlgo Fax: ++ 52 (55) 525 47858
MX - 11590 Mxico, D.F. E-mail: anfpa@anfpa.org
Mexico URL www.anfpa.org
NETHERLANDS
NEA Vereniging van Geur en Smaakstoffenfabrikanten
Loire 150 Tel.: ++ 31 70 33 78 787
P.O. Box 443 Fax: ++ 31 70 33 78 737
SINGAPORE
FFAS Flavour and Fragrance Association of Singapore
c/o I.F.F. Tel.: ++ 65 6559 1335
41 Science Park Road, #02-22 The Gemini Fax: ++ 65 6777 4041
Singapore Science Park II E-mail: kok.sian.ng@iff.com
SG - 117610 Singapore
Singapore
SPAIN
AEFAA Asociacin Espaola de Fragancias y Aromas Alimentarios
P de la Castellana 159-1 A Tel.: ++ 34 91 571 1640
ES - 28046 Madrid Fax: ++ 34 91 571 6163
Spain E-mail: aefaa@aefaa.com
URL www.aefaa.com
SWITZERLAND
SFFIA Swiss Flavour and Fragrance Industry Association
Industriestrasse 9 Tel.: ++ 41 44 835 76 17
CH - 8305 Dietlikon Fax: ++ 41 44 835 76 80
Switzerland E-mail: contact@sffia.ch
URL www.sffia.ch
TURKEY
AREP Association of Flavourings and Essential Oils Producers
Sehit Muhtar Cad. No:36 Cat:4 Tel.: ++ 90 212 256 11 40
TR 34437 Taksim, Istanbul Fax: ++ 90 212 237 17 46
Turkey E-mail: aromsa@aromsa.com.tr
UNITED KINGDOM
IFRA United Kingdom
PO Box 173 Tel.: ++ 44 7909 916413
Cranleigh Tel: ++ 44 1908 635004
Surrey GU6 8WU E-mail: lisa@ifrauk.org
United Kingdom E-mail: julie@ifrauk.org
UNITED STATES
IFRA North America
1620 I Street NW Tel.: ++ 1 202 331 2322
US - Washington DC 20006 Fax: ++ 1 202 463 8998
United States of America E-mail: info@fmafragrance.org
URL: www.fmafragrance.org
Supporting Members
Chemotrade (2004) A.M. Ltd.
3 Timna St. Holon Tel: ++972 3 5584 330
PO Box 67 Fax: ++972 3 5584 357
Azur 58190 Email: chemotrade@chemotrade.net
Israel URL: www.chemotrade.co.il
IFRA Committees
Natural Experts TF
Mission: On behalf of industry, to provide expert advice to the IFRA Secretariat and Committees on natural materials,
e.g. with regard to composition.
The IFRA ETF is a task force consisting of environmental scientists that will advise the Scientific Committee (SC)
regarding the environmental safety of fragrance materials and assist in the identification and management of
environmental issues related to their use. The ETF will report directly to the IFRA SC, coordinate its activities with
RIFM, and will respect RIFMs independence through its scientific advisory panel (REXPAN).
Mission: To promote an overall strategy for continuous improvements in the flavor and fragrance industrys safety,
health and environmental programs and initiatives by:
Exchanging information and experiences with occupational safety, health and environmental programs, incidents and
accidents in the workplace;
Preparing and issuing guidance on occupational safety, health and environment issues relevant to the flavor and
fragrance industry;
Communicating, as appropriate, with national/regional member associations and/or relevant bodies in IFRA and IOFI;
Reviewing both existing and proposed legislation relevant to occupational safety, health and environment, and to
advise members accordingly.
N.B.: The environmental fate of fragrance ingredients following their use in consumer products is dealt with by the
ETF and the SC.
Mission: The GHS TF will deal with all aspects linked to the global classification and labeling of fragrance and flavor
ingredients by:
Monitoring the global development and implementation of GHS and related regulation
Classifying fragrance and flavor materials following the criteria laid out in the UN GHS guidance document. UN
transportation classifications, US OSHA and EU DSD classifications will also be assigned as long as those
remain active.
Coordinating the communications activities of national/regional member associations to assure that the industry
speaks with a consistent voice on matters of common concern;
Providing technical advice and assistance to the management, staff, and members of IFRA and RIFM;
Staying abreast of political, regulatory and legislative developments relevant to the industry's public posture and
status;
Coordinating with customer trade associations;
Managing public relations consultants employed by IFRA;
Developing a crisis management plan for IFRA and the fragrance industry;
Providing a forum for discussion and resolution of issues with the communications community as well as issues
between the communications group scientists, management and others.
The Communications Working Group develops an overall public relations strategy taking into consideration the goals
of IFRA and RIFM as well as the available resources.
The Communications Working Group includes cross-disciplinary membership, including senior business managers,
as well as communications, regulatory and scientific experts.
IFRAs efforts are further supported by other Committees and Task Forces as required.
Article 1
An international, not-for-profit association with scientific objectives is established under Swiss law [art. 60 et seq. of
the Civil Code (CC)] with the title of International Fragrance Association (IFRA) with headquarters in Geneva,
hereafter the Association.
Purpose
Article 2
The purpose of the Association is to serve and advance the collective interests of the fragrance industry, worldwide,
with the final objective to protect the consumer and the environment.
Membership
Regular Members
Article 3
Any company engaged primarily in the manufacture of fragrances and not selling to retail distribution and with
worldwide operations in all four regions: Europe (including Africa and Middle East); North America (including
Ifra operations Ifra Headquarters
Avenue des Arts, 6 1210 Brussels Belgium Rue du March, 9 1204 Geneva, Switzerland
T +32 (0)2 214 20 60 F +32 (0)2 214 20 69
Ifraorg.org
Canada); Latin America (including Mexico) and Asia (including Australia) shall be eligible for Regular Membership,
provided it pays the dues associated with their status.
Each Regular Member shall have voting rights as further provided in these By-laws (Appendix 1) or as required by
law.
Association Members
Article 3a
National Associations comprised of companies in the fragrance industry shall be eligible for Association Membership.
Association Members shall have voting rights through Regional Committees, as approved by the General Assembly
(Art. 8).
National Associations are grouped into four geographic Regional Committees. These committees are: Europe
(including Africa and Middle East); North America (including Canada); Latin America (including Mexico) and Asia
(including Australia).
Supporting Members
Article 3b
Individual companies who manufacture, market, or distribute fragrances or fragrance ingredients and not selling to
retail distribution may apply for membership in the Association as Supporting Members, provided that there is no
association in their country already member of IFRA.
Supporting Members are required to pay an annual fee determined by a vote of the General Assembly.
Article 4
All members may withdraw from the Association only after sending their resignation by registered letter to the General
Secretariat (Art. 21), with the withdrawal to become effective at the end of the following quarter.
Article 5
Any member not conforming to any part of these Bylaws may be expelled by decision of the General Assembly acting
in accordance with Article 8. The member in question shall always have the right to present its defense prior to such
action.
Article 7
A member who leaves the Association by resignation, acquisition, expulsion or for any other reason shall have no
claim on the funds of the Association but shall remain liable for its full subscription for the membership for 12 months
after the date of notification.
Member Representatives
Article 8
Each Regular Member shall designate an individual as its official representative to the Association.
Each Regional Committee shall designate an individual to serve as its official representative to the Association. Any
one company should not have more than one representative to the Association unless a Regional Committee cannot
find a suitable alternative.
The name of representatives must be communicated to the General Secretariat. Such appointments may be changed
at any time.
General Assembly
Article 9
The Regular Members and Regional Committees representatives shall meet in ordinary General Assembly at a
minimum of once a year under the chairmanship of the Chairman of the Association, on a date and at a place
determined during the previous General Assembly of the Regular Members and Regional Committees.
The Chairman of the Association may call an extraordinary General Assembly at any time. He must call such a
meeting upon request of Regular Members and / or Regional Committees holding at least one fifth of the voting
rights.
Any Regular Member or Regional Committee of the Association may add topics to the agenda provided that a request
for same be received by the General Secretariat at least fourteen days before the scheduled ordinary or extraordinary
General Assembly date. The General Secretariat will immediately send notice of such additions to all other members.
Article 10
The voting rights of the Regular Members are reflective of their share of the Association dues, provided that each
Regular Member shall have at least three votes. The General Assembly shall determine the formula (see Appendix
Each Regular Member is empowered to vote, through its representative, on all matters debated during the General
Assemblies of the Regular Members and Regional Committees, unless delinquent in the payment of its dues to the
Association on the date of such vote.
Any Regular Member may give a general or special proxy to another Regular Member as long as the General
Secretariat is notified in advance of the meeting by written notice.
Each Regional Committee vote shall be exercised through its designated representative. Any Regional Committee
may give a general or special proxy to another Regional Committee as long as the General Secretariat is notified in
advance of the meeting by written notice.
Article 11
The Regular Members and Regional Committees may conduct a General Assembly if at least two-thirds of the voting
rights are present or represented. If this quorum is not reached, another General Assembly must be scheduled
between the eighth and fifteenth day following the adjourned General Assembly and subsequently, until a quorum is
obtained.
Any decision of the Regular Members and Regional Committees shall require approval by at least two thirds of the
voting rights represented at the General Assembly except in the case of changes in the Code of Practice or Bylaws
of the Association where three quarters of the voting rights including the vote of at least one regional committee will
be required. Decisions may be taken by an electronic vote, when necessary.
It is possible to act on matters, which are not on the agenda in cases of urgency and with the consent of a three-
quarters majority of the voting rights present or represented by proxy. The addition of an urgent matter to the agenda
will be proposed not less than 48 hours before the meeting.
Board
Article 12
The Association shall be administered and directed by its board of directors (the Board) consisting of one
representative for each Regular Member and one representative for each Regional Committee.
Article 13
All competences not residing with the General Assembly pursuant to these Bylaws or to any mandatory provision of
the law governing the Association shall be with the Board.
Article 14
Article 15
A Vice-Chairman of the Association is to be elected by the Regular Members and Regional Committees at the
proposition of the Chairman at a General Assembly.
The Vice-Chairman will assist the Chairman in fulfilling his task. He will replace the Chairman whenever the Chairman
is unavailable.
The Vice-Chairman will be elected for a term of office which will expire at the same time as the term of office of the
Chairman who has proposed him. At the expiration of the term of the Chairman, the Vice-Chairman must be confirmed
Chairman for two years by the General Assembly, at which time he will propose a new Vice-Chairman.
If the Chairman resigns before the end of his term of office, the Vice-Chairman will replace him as Acting-Chairman
until the normal expiration of term. The Acting-Chairman will then need to be confirmed as Chairman for another one
year.
Article 16
A Secretary-Treasurer of the Association is to be elected by the General Assembly for one year.
Article 17
The Chairman shall preside over General Assembly and over meetings of the Board, but he may delegate his powers.
The Chairman is responsible to all members for the functioning of the Association.
Article 18
A member of the Board may be represented at a meeting of the Board by a person that has been duly authorized
pursuant to a written document mentioning that the person representing the Regular Member or the Regional
Committee member has the full power and is entitled to vote and otherwise act on behalf of the member he or she
represents.
Article 19
The Board will meet at the discretion of the Chairman. A quorum shall consist of at least two thirds of the members
present or represented. Decisions must be adopted by a two-thirds majority of the members present or represented.
Article 20
The Chairman shall have the authority to sign all documents binding the Association without further proof of specific
authorization if there are no specific proxies. The Association shall be legally bound by the Chairman or the President.
General Secretariat
Article 21
The position of President, to direct the General Secretariat, can be created by decision of the General Assembly.
The President shall act as chief executive officer of the association.
The President is appointed by the General Assembly and is obligated to follow decisions of the General Assembly
as well as directives of the Board. Furthermore, he has to discharge his duties objectively and in agreement with all
legal statutes. He reports to the Chairman and will cooperate closely with all bodies of the Association as well as with
the staff of the General Secretariat.
Article 22
The General Secretariat shall perform the activities and functions with which it has been entrusted by the Board.
Article 23
The Board of the Association is empowered to establish standing Committees and Task Forces as needed in pursuit
of its purpose.
Article 24
The members of each standing Committee shall be approved by the Board. The Chairman has the power to appoint
the members of temporary Committees and Task Forces to pursue a task limited in scope and time.
Article 25
Regular members subscription to the Association shall be determined annually by the General Assembly acting in
accordance with Article 8. Regular members will pay all fragrance industry dues (except nominal dues to selected
associations) to IFRA.
Article 26
Each Regular member of the Association shall be liable for the subscription determined by the General Assembly.
The commitments of the Association are covered only by the assets of the Association. Personal responsibility of the
members is excluded.
Article 27
The fiscal year commences on January 1st and ends on December 31st of the same year.
Article 28
The Board shall submit annually, for the approval of the General Assembly, the accounts of the previous financial
year and the budget for the coming fiscal year.
Article 29
The text of any proposed amendment to the Bylaws shall accompany the notice of a General Assembly, which will
consider the matter in accordance with Article 8.
Article 30
The Association is dissolved when it is insolvent, when the Board can no longer be constituted according to the
Bylaws or upon decision of the General Assembly of Memberships. In the event that the Association is dissolved, the
available assets shall be entirely attributed to an organization of public interest that pursues similar purposes to the
Association. In no case shall its assets be returned to the founders or to the members, nor used for their benefit, in
part or whole, in any manner whatsoever, unless as provided above.
General Rule
Article 31
Any subject not contained in the present Bylaws will be settled according to the provisions of Swiss law.
Signature:
Estimated Total
Votes Members Votes
Member Companies
Companies contributions over $2 million 4 3 12
Companies contributions $200k - $2 million 3 3 9
Total Member Votes 21
Regional Committees
North America 3* 1 3
Europe 3* 1 3
Asia 2* 1 2
Latin America 1* 1 1
Total Votes 30
Code of Practice, Standards setting and bylaw changes requires a three quarter majority
including the vote of at least one Regional Committee - 23 votes
*based on market share
All other decisions require 2/3 majority - 20 votes
1. Assistance to Physicians
Fragrance manufacturers shall cooperate with and give full assistance to physicians in attempting to discover the
causative agents of clinical dermatitis or other adverse reactions in individual patients (see also last paragraph of
item 3 in this document).
Under the laws of virtually all countries, fragrance formulae enjoy trade secret protection when maintained in strict
confidentiality toward third parties and even within the creating company itself, where only a limited number of
employees have access to the complete formulae.
Copyright protection has been recognized to include eligible creations perceived by smell in some countries where
fragrance formulae can benefit from such protection.
Trade secrets or copyright protection of fragrance formulae thus preserves the uniqueness of the fragrance often
the principal distinguishing feature of the product in which it is used for the customer for whom it was created.
Misappropriation of trade secrets in, or illegal copying of, fragrances or fragrance formulae would allow violators to
unfairly appropriate fragrance exploitations without bearing any of the original creative effort and development costs.
The fragrance industry and all IFRA members are committed to respecting fragrance formulae intellectual property
against unlawful misappropriation and shall not infringe third parties intellectual property rights. They further support
legislative, regulatory or other appropriate actions taken to reinforce, expand and protect the intellectual property on
fragrance formulae against unlawful third party infringement or misappropriation.
a) The fragrance manufacturer, in cooperation with the consumer product manufacturer, make such disclosures of
information as are required under applicable legislation and regulation, or as are appropriate under the
circumstances to satisfy government bodies that fragrance ingredients in finished products are safe for the
consumer and the environment.
b) The fragrance manufacturer, in cooperation with the consumer product manufacturer, respond promptly to
requests for information from physicians treating patients who are suspected of having suffered adverse reaction
to products containing fragrances.
Ingredient Evaluation
Fragrance ingredients that deviate from generally accepted quality standards should be used only after satisfactory
evaluation according to the requirements set forth in this Annex.
The IFRA Scientific Committee will collect and make available to RIFM data that are relevant for the safety evaluation
of fragrance ingredients. This may include ingredient volume of use, ingredient use level in fragrance compositions,
as well as data from the scientific literature, results of testing programs made available by the originators of such
programs, and validated reports of adverse reactions to fragrance materials.
Safety data for all fragrance ingredients that are commercially available and offered for sale as such must be
submitted by the ingredient manufacturer to RIFM for inclusion in the Fragrance Ingredient Database. Manufacturers
must provide all available information on specifications, use and use levels as well as copies of test reports and other
safety related information for examination by the REXPAN (RIFM Expert Panel). In particular, when fragrance
manufacturers have evidence that warrants creation or modification of a Standard, they shall inform IFRA and supply
the data to RIFM.
Also critical to a thorough human health safety assessment of individual fragrance ingredients are data on levels of
use, and routes of exposure of consumers. These data are determined from a collaborative effort of IFRA and various
cosmetic companies or trade associations, with the data being analyzed and summarized in documents prepared by
IFRA.
Possible environmental fate and effects should also be considered in the assessment of a substances use including
route of environmental exposure, possible degradation, metabolism and the environmental safety of their
metabolites/degradates.
For the evaluation of a fragrance ingredient, consideration should be given to possible effects on the skin, including
skin irritation and sensitization, with special attention paid to the effect of sunlight in cases where the ingredient
reveals UV-absorbing properties.
Systemic toxicity should be considered in relation to the quantities of a fragrance ingredient used and its likelihood
of entry into the human body.
All data collected as described above are communicated routinely to RIFM, for consideration by REXPAN.
As a result of safety assessments, the usage of certain fragrance ingredients may be restricted and these restrictions
are set forth in IFRA Standards (see Appendix 8).
In order to effectively apply the Code of Practice to the manufacture and handling of all fragrance materials, fragrance
manufacturers should take all measures to assure that any fragrance compound offered for sale is in full compliance
with the requirements of the Code of Practice and all applicable Standards.
Guidance Documents
The following guidance documents relate to the specifics for human health and environmental effects evaluations as
well as to IFRA procedures on how to provide estimates of consumer exposure to fragrance ingredients:
2. Environmental Effects
A methodology for conducting a preliminary aquatic risk assessment for fragrance materials can be found in the
Environmental Framework Document which has been published as A framework for prioritizing fragrance materials
for aquatic risk assessment, D.T. Salvito, R.J. Senna, and T.W. Federle, Environmental Toxicology and Chemistry,
21(3): 1301-1308 (2002).
4. Exposure Assessment
A description on how fragrance industrys procedures for estimating exposure to fragrance ingredients through
different routes and leading to different potential endpoints has been published as Consumer exposure to Fragrance
Ingredients: Providing Estimates for Safety Evaluation, P.A. Cadby, W.R. Troy, and M.G.H. Vey, Regulatory
Toxicology and Pharmacology, 36: 246-252 (2002).
Basic Approach
The following paragraphs formulate basic recommendations for good operating practice by the fragrance industry.
The application of these recommendations does not relieve individual manufacturers from the obligation to comply
with all national or international regulations that pertain to their operations.
Personnel
Any fragrance materials manufacturing center should employ personnel with adequate levels of technical and
practical training and with the authority and responsibility, to ensure and maintain the identity, purity and quality of
the products manufactured.
In order to avoid contamination of a fragrance material or its packaging, all personnel involved in their manufacture
and handling should practice good personal hygiene and be free from skin disorders or infections.
Eating, smoking and unhygienic practices should not be permitted in compounding and packaging areas.
Sufficient clean and well-ventilated toilet facilities, including facilities for hand washing and changing of clothes should
be available near the working areas for the use of manufacturing personnel.
Quality Assurance
Predefined properties of all fragrance ingredients and finished products should be monitored and controlled by a
quality control department directed by a qualified person reporting to management and independent of other
departments. This department should operate according to defined procedures, with the responsibility and authority
to approve or reject the evaluated materials.
The laboratory facilities available to the quality control department should be staffed and equipped commensurate
with the requirements of effective quality control.
Quality assurance procedures should define in sufficient detail the taking of samples, including the quantities, tests
to be performed, sample retention, and the schedule for release of the results. QA samples should be uniquely
labeled, with reference to the date and batch number. Samples should be stored under suitable conditions for future
reference.
The quality assurance department should maintain adequate records regarding the specification and test results of
each batch.
For all ingredients and products, records should be kept permitting identification of the batch, the production history
or origin, and defining dates for the various control steps, including release by the quality assurance department.
During the period between their arrival from the supplier or from the production center and their use in fragrance
compounding or shipment to the customer, all fragrance ingredients should be stored under conditions compatible
with their physical and chemical properties.
Ingredients that have been rejected for any reason should be designated accordingly, quarantined either physically
or electronically, and treated in accordance with the nature of the rejection.
Manufacturing Operations
All manufacturing systems should be supervised and operated by qualified personnel, trained according to defined
procedures in unit operations.
For all manufacturing equipment and utensils, adequate cleaning instructions should be available as well as qualified
personnel responsible for the proper execution of these instructions and for the cleanliness of the equipment prior to
its use.
All manufacturing equipment should be designed and maintained to make it suitable for its intended use.
All manufacturing equipment should be installed in the production premises in positions facilitating cleaning and
maintenance and minimizing contamination during its use.
Weighing and measuring equipment used in production and quality control should be calibrated and checked for
accuracy at suitable intervals by appropriate methods.
The contents of all vessels and containers used in manufacture and storage between manufacturing stages should
be identified by conspicuously placed and clearly legible labels, bearing the name and/or identification code of the
processed materials and the necessary batch identification data.
In the case of continuous operations, batch records per se may not be possible. Instead, a continuously updated file
or automated data collection can be used to permit without delay a review of the production history of the contents
of any particular container.
Manufacturing records should be kept providing a complete record of the manufacturing history of each batch of a
fragrance material, showing that it has been manufactured according to the relevant process documentation and that
its properties have been measured and controlled in accordance with relevant specifications.
For each batch meeting the requirements of the relevant specifications, a quality control report should be made, duly
authorized by the person responsible for quality assurance.
All packages and containers of finished products should be identified by labels complying with applicable legislation
and mentioning the name, code and batch number of the product, its weight, and any special storage and handling
instructions.
Field of Application
This section applies to the manufacture and handling of all fragrance materials, including storage, production and
plant design. It may require revision if future developments in the industry make it necessary.
The application of this section does not exempt individual manufacturers from the obligation to comply with all national
or international regulations, which are relevant to their operations.
Basic Principles
The protection of health in the workplace and the protection of the environment are of primary concern to the
fragrance industry. This section expresses a determination to protect human health and the environment from
adverse effects.
Risks to human health and the environment shall be minimized by taking all appropriate precautions and actions
which are practicable, compatible with operational requirements and consistent with local conditions and national
regulations. Measures taken should be appropriate to the degree of risk involved.
Free exchange of information on health and environmental subjects among individual companies is encouraged.
Health Protection
All personnel involved in the manufacture and handling of fragrance materials should be protected from health
hazards of a physical nature (e.g. noise, radiation, vibration) or chemical effects of gases, vapors or dusts.
Efforts should be made to eliminate or minimize exposure to health hazards by taking those precautions, which are
necessary in the light of experience, feasible according to the state of technology and appropriate to the operating
conditions.
If technical and organizational measures are not sufficiently effective, personal protective clothing and equipment
should be worn such as respiratory protection (face mask, breathing apparatus, etc), eye and ear protection (safety
glasses, face visor, ear plugs, etc.), hand and body protection (gloves, suit, apron, shoes, etc.).
Specific information and instructions on required protective measures should be provided to personnel in order to
avoid health hazards in the workplace.
Companies should periodically audit any of their workplaces which have potential health hazards, with regard to
health protection performance. If necessary, exposure-monitoring surveys should be carried out.
Where law requires no safety data sheets, recommendations on storage and handling should nevertheless be
provided to customers.
Environmental Protection
The environment should be protected from adverse effects by appropriate organizational and technical measures.
Pollution affecting water, air, soil and public health should be avoided.
Emissions, which can have an adverse effect on the environment, should be identified, assessed and, if necessary,
reduced.
Provision should be made to avoid accidental discharges into the environment, which could pose a risk to health of
personnel or the general public, or could have adverse effects on the environment.
Awareness of environmental protection should be developed among all personnel handling materials and they should
be instructed on emergency procedures in case of accidental discharge.
Recommendations should be provided to customers on storage and handling precautions in those cases where this
is required to protect the environment.
Provision should be made to avoid discharging polluting materials into surface water drains.
Technical and administrative measures should be taken to avoid the accidental discharge into the
atmosphere of quantities of materials hazardous to health or to the environment.
Technical and administrative measures should be taken to avoid contamination of groundwater arising
from soil contamination.
Chemical wastes shall be disposed of according to local, national or international legal requirements.
Only officially approved disposal sites shall be used.
The most appropriate disposal methods should be selected for each waste so as to ensure adequate
protection of the public and the environment. Currently, incineration is to be preferred to land filling,
wherever possible.
Appropriate waste management methods should be applied. Adequate records of all disposed wastes
should be kept. Landfill disposal records should be held indefinitely.
Definitions
Batch: A specific quantity of material of homogeneous composition that can be unambiguously identified,
manufactured in a single operation or a series of operations according to a well-defined process.
Batch number: A unique combination of letters and/or numbers printed, stamped or written on labels or packaging
materials, which uniquely identifies a batch and which permits the tracing and review of all stages of its production
history.
Environment: Water, air and soil and their inter-relationship as well as relationship between them and any living
organisms.
Fragrance or Fragrance compound: A mixture of fragrance ingredients and functional components formulated to
impart an odor/flavor* or for its malodor coverage/taste making*.
*in the case of oral care and related products, please see respective explanations and requirements in the
Introduction to the Standards
Existing fragrance compound (see also New submission): A compound currently sold for use or already the
subject of evaluation for performance in a defined consumer product.
Explanatory note: the period of time permitted to achieve compliance with a new or revised Standard (see section
3.2 of the Code) applies only to that compound in that defined consumer product.
Fragrance ingredient/material: Any basic substance used as a fragrance material for its odor properties or
malodor coverage.
Fragrance Functional Component: Any basic substance necessary for the functionality and/or, stability of a
fragrance ingredient or compound (e.g. antioxidant, preservative, diluents, solvent, etc.).
Manufacturing: All operations involved in the production of a fragrance material including processing, compounding,
packaging and labeling.
Fragrance manufacturer: A company engaged in the production of a fragrance including processing, compounding,
packaging and labeling.
Fragrance material manufacturer: A company engaged in the production of any basic substance used as a
fragrance material for its odor properties or malodor coverage.
New submission (see also Existing fragrance compound): Any fragrance, new or existing, which does not fall
within the definition of an existing fragrance compound.
Quality: Conformity of a fragrance material with its olfactory, physical and chemical specifications and conformity of
its production and control with the basic standards of good manufacturing practice.
Standard: Mandatory restriction to the usage of a fragrance ingredient following a safety assessment by the
REXPAN. (In this meaning the word starts with a capital S).
Toy: Toys under the scope of IFRA Standards follow the definition as contained in the EU Toy directive (2009/48/EC)
and the American National Standard ASTM F963, in its latest version.
Waste: Any unavoidable material, resulting from an industrial process, which must be disposed of.
Phototoxic Ingredients
Combination effects of phototoxic ingredients are only taken into consideration for
furocoumarin containing ingredients (extracts).
The scope of application of restrictions based on phototoxic effects excludes certain skin
contact applications where the area of the body where the product will be applied would not
reasonably be expected to be exposed to light (e.g., tampons or intimate wipes). The
comprehensive list of product applications within the scope is contained in Table 4 of the QRA
booklet, which is distributed with each Amendment.
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Contributions from Other Sources
Prohibited Substances
An IFRA Standard may ban the use of a substance when it is intended to be used as such in
a fragrance compound. However, this does not necessarily exclude the use of a fragrance
material (natural or synthetic) which contains the same substance as a component or
contaminant provided, in the judgment of the RIFM Expert Panel (REXPAN), there are
sufficient data supporting the safe use of the fragrance material, and that it is not being used
to provide an alternative, indirect source of the banned substance.
One source of prohibited substances is the small amounts of organic solvents that might be
carried over into a synthetic fragrance ingredient or an organic extract during the
manufacturing process. There are specific steps within a synthetic pathway that are designed
to remove minor amounts of solvents, but these steps are inevitably not completely successful
in removing traces of the substances. These processes may result in extremely low, technically
unavoidable traces of substances in the final fragrance material. Where feasible, IFRA
develops guidance regarding maximum accepted limits for these substances that have been
reviewed and approved by the RIFM Expert Panel.
In general, fragrance materials which are single chemicals or essential oils (in any form) should
be analyzed to identify components or impurities (especially those that are prohibited) at levels
that allow a meaningful safety assessment.
Every IFRA member becoming aware of IFRA prohibited materials in fragrance ingredients at
levels not addressed by the respective IFRA Standards (in the Standard or as an impurity), is
obliged to inform IFRA/RIFM, so that an adequate safety evaluation by REXPAN can be carried
out. Certain essential oils may act as a second source from which the banned substance
cannot be removed.
If REXPAN based on a risk assessment of the presence of a banned substance in other
fragrance materials (either a synthetic chemical or natural complex substance) finds this
presence cannot be supported, the chemical or natural complex substance will itself be
prohibited from use.
However, if the levels of the banned substance as such are assessed as being of no concern
or can be reduced to a safe level, then an IFRA Standard will be established to allow the use
of the chemical or natural complex substance by setting a limit for the presence of the banned
substance (e.g. Atranol and Chloroatranol in Oakmoss and Treemoss, or Toluene as a solvent
residue).
Restricted Substances
IFRA Standards establishing use restrictions for specific fragrance materials in final consumer
products shall apply regardless of whether the restricted substance is added directly or
indirectly. Those contributions from other sources must be taken into account in the calculation
of the levels of the restricted substance.
Annex I to the IFRA Standards provides indicative levels of restricted substances in a non-
exhaustive list of various fragrance ingredients of complex composition, including essential
oils. These indicative levels should be taken into account when determining the compliance of
a fragrance compound under its conditions of use. However, if actual analysis has shown that
the level of the limited substance in a specific fragrance ingredient is not the same as the
indicative level given in Annex I, then the analyzed level can be used instead of the indicative
level.
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Fragrance manufacturers are invited to:
(a) Also use for the purpose of calculation additional information they may have on levels
of the restricted substances in any other essential oil, extract, etc. used as fragrance
ingredients, but not already mentioned in Annex I to the IFRA Standards;
(b) Provide to IFRA/RIFM information on those substances and levels.
Oral Care Products and other products with the potential of ingestion
In general, IFRA Standards are applicable for fragrance compounds used in non-food
products.
To avoid confusion, for the purpose of the IFRA Code of Practice, when referring to single
ingredients and mixtures we talk about fragrance ingredients and fragrance compounds
(perfume) respectively, even if the ingredients and mixtures in the end are fulfilling flavour
requirements and are in fact produced as flavour compounds and could thus be legitimately
termed flavour.
All oral care products that carry a fragrance, like any other fragranced product, must follow the
IFRA Standards and general guidelines as contained in the IFRA Code of Practice.
Standards for oral care products, when based on the dermal sensitization QRA, only address
the issue of the endpoint of sensitization.
Mouthwash and toothpaste are the principal oral care products currently identified in the
respective category resulting from the QRA. Exposure limits for these products are established
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to reduce the risk of peri-oral skin sensitization and, as such, are not related to considerations
of safe levels for ingestion.
Besides oral care products there are certain other products containing fragrance materials that
are not intended for ingestion but have the possibility of ingestion of minute amounts of the
fragrance ingredients, like lip products of all types (solid and liquid lipsticks, balms etc.) or
specific types of toys.
Due to the possibility of ingestion of small amounts of fragrance ingredients from the use of
the aforementioned allowable product categories (such as oral care, lip products or certain
types of toys), materials present in the fragrance compound must not only comply with IFRA
Standards but must also have an approved flavour materials status as defined by the IOFI
Code of Practice. Such materials are those that meet one or more of the following
requirements:
(a) Accepted by the authoritative body the Joint FAO/WHO Expert Committee on Food
Additives (JECFA) as acceptable flavoring materials that pose no safety concerns at
current levels of intake;
(b) Have been evaluated and found, using the same or similar methodology as used by
JECFA, to present no safety concern under conditions of intended use by
authoritative bodies such as the European Food Safety Authority (EFSA) or the
Japanese Food safety Authority (FSC);
(c) Deemed to be Generally Recognized As Safe (GRAS) or approved food additives by
the US Food and Drug Administration (FDA) including GRAS determinations published
by the independent Expert Panel of the Flavor and Extract Manufacturers Association
of the United States (FEMA);
(d) Are compliant with appropriate national/regional regulation covering the use of
flavorings for local use and respective product uses as outlined above.
Materials without an approved flavor status according to the criteria above are not permitted in
products where incidental oral ingestion may occur.
The safety of (fragrance) materials present in products intended for ingestion (like ingestible
perfumes or deodorants) is outside the scope of IFRAs risk assessment process.
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