Form 1: Proposal for a new field oftechnical activity
Circulation date:2016-10-15
Closing date for voting:2017-01-15

Reference number(to be given by Central Secretariat)

Proposer :ISO/TS/P

ISIRITS/P 264

A proposal for a new field of technical activity shall be submitted to the Central Secretariat, which
will assign it a reference number and process the proposal in accordance with the ISO/IEC
Directives (part 1, subclause 1.5). The proposer may be a member body of ISO, a technicalcommittee, subcommittee or project committee, the Technical Management Board or a General
Assembly committee, the Secretary-General, a body responsible for managing a certification system
operating under the auspices of ISO, or another international organization with national bodymembership. Guidelines for proposing and justifying a new field of technical activity are given in theISO/IEC Directives (part 1, Annex C).
The proposal (to be completed by the proposer)
Title of the proposed new committee (The title shall indicate clearly yet concisely the newfield of technical activity which the proposal is intended to cover.)
Medicinal Plants
Scope statement of the proposed new committee (The scope shall precisely define thelimits of the field of activity. Scopes shall not repeat general aims and principles
governing the work of the organization but shall indicate the specific area concerned.)Standardization in the field of medicinal plants as well as medicinal plants propagation materials,
in particular terminology, sampling, test methods and analysis, product specifications, safety andquality requirements for packaging, storage and transportation . Medicinal plants substances withregard to safety and quality such as content of active material, values for physical, chemical
specifications and microbial contaminants, chemical residues and heavy metals etc., must be
based on recognised international standards or deliverables and should be laid down in written
form.
Excluded from its scope are products covered by ISO/TC 54 Essential oils, ISO/TC 245
Traditional Chinese Medicine and ISO/TC 215 Health Informatics.

FORM 1 – Proposal for a new field of technical activity
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Proposed initial programme of work (The proposed programme of work shall correspondto and clearly reflect the aims of the standardization activities and shall, therefore, show
the relationship between the subject proposed. Each item on the programme of wo rk shallbe defined by both the subject aspect(s) to be standardized (for products, for example,
the items would be the types of products, characteristics, other requirements, data to besupplied, test methods, etc.). Supplementary justification may be com bined withparticular items in the programme of work. The proposed programme of work shall alsosuggest priorities and target dates.
Medicinal plants committee is mainly responsible for making medicinal plants development planof international standards, developing and revising the international standard. Initial work
programme in the proposal as follows :-Basic standards such as “Terminology of Medicinal Plants”;-Hygiene requirements for Medicinal Plants;-Safety requirements for Medicinal Plants;-Technical requirements for Medicinal Plants;-Quality control standard for Medicinal Plants ;-Characterization and specification requirement for Medicinal Plants;-Transportation and storage requirements for Medicinal Plants;-Packaging requirements for Medicinal Plants;
Medicinal Plants terminology is fundamental for standard development in the field.
Hygiene and safety requirements can be used by medicinal plants handling and processing
system to provide assurance to consumers on safety and quality of products .
The priority of work will be establishing Terminology, classification, cost and productivity
standards that will resonate with the market place and provide immediate value to consumers
Indication(s) of the preferred type or types of deliverable(s) to be produced under theproposal (This may be combined with the "Proposed initial programme of work" if moreconvenient.)
The deliverables from this work would include ISO standards.
A listing of relevant existing documents at the international, regional and national levels.
(Any known relevant document (such as standards and regulations) shall be listed,regardless of their source and should be accompanied by an indication of theirsignificance.)
The relevant existing documents are as follows:
WHO: Guideline and EC directive on traceability of Herbal raw material:
ISO standards: ISO 17351:2014, ISO 15378:2011
Iran national standards: IS 5103:2000, IS 5310:2001, IS 2599:2003, IS 3741:2005, IS 410:2000,IS 6399:2001, IS 438:2000, IS 433:2001, IS 2459:1989, IS 3277 :1991, IS 11078:2000, IS 2815:1988,IS 251:1995, IS 3358:1998, IS 3359:1998.
British national standard : BS EN 16679:2014 .
A statement from the proposer as to how the proposed work may relate to or impact on
existing work, especially existing ISO and IEC deliverables. (The proposer should explain
how the work differs from apparently similar work, or explain how duplication and conflict
will be minimized. If seemingly similar or related work is already in the scope of othercommittees of the organization or in other organizations, the proposed scope shalldistinguish between the proposed work and the other work. The proposer shall indicate
whether his or her proposal could be dealt with by widening the scope of an existingcommittee or by establishing a new committee.)
There will be no work scope and deliverable overlap or conflict between the proposal and othertechnical committees or sub-committee of ISO and IEC .

A listing of relevant countries where the subject of the proposal is important to theirnational commercial interests.
This proposal will be commercially beneficial to all countries that manufacture or use medicinal
plants, especially to those countries that produce large numbers of medicinal plants, such as
China, USA, India, Iran, Germany, Britain, Japan, Turkey, Italy , South Africa, Australia, Pakistan,Afghanistan, etc. Those countries that export large numbers of medicinal plants, such as China,UAS, Iran, India, Italy, South Africa, Australia, Canada, Spain , Pakistan, etc .

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A listing of relevant external international organizations or internal parties (other ISOand/or IEC committees) to be engaged as liaisons in the development of thedeliverable(s). (In order to avoid conflict with, or duplication of efforts of, other bodies, itis important to indicate all points of possible conflict or overlap. The result of any
communication with other interested bodies shall also be included.)
Medicinal technical committee will actively seek opportunities to coordi nate and liaison withmany international organizations below. As propose of this proposal does not overlap orconflict with work scope or deliverable of any technical committee of ISO.
However, Medicinal plants are used in the production of medicine. Medicinal plants also
requires development of special safety and quality standards, thus the proposal would seek
contact with the following technical committee or subcommittee for communication in the studyof standardization:
ISO/IEC Technical committees:
ISO/TC 34, Food products;
ISO/TC 54, Essential oils;
ISO/TC 84, Devices for administration of medicinal products and catheters;
ISO/TC 215, Health informatics;
ISO/TC 217, Cosmetics;
ISO/TC 249, Traditional Chinese Medicine;
ISO/TC 276, Biotechnology;
ISO/TC 34/SC 7, Spices;
ISO/TC 34/SC 8, Tea.
The proposal would seek contact with the following international organizations in the study ofstandardization:
WFAS (World Federation of Acupuncture and Moxibustion Societies);
WHO (World Health Organization);
FAO (Food and Agriculture Organization);
UNESCO (UN Economic and Social Council);
UNDP (United Nations Development Program);
UN (United Nation);
WFPMM(World Federation of Propertary Medicine Manufactures);
WWF(World Wild Fund for Nature);
IUCN(International UNION for Conservation of Nature and Natural Resources);
IHTSDO (International Health Terminology Standards Development Organization).

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A simple and concise statement identifying and describing relevant affected stakeholder
categories (including small and medium sized enterprises) and how they will each benefit
from or be impacted by the proposed deliverable(s).
All medicinal plants at stakeholders, including consumers, industries, governments/regulatoryorganizations, national and international traders and researchers will benefit from and be
affected by the proposed deliverables.
Medicinal plants obtained from wild habitats are found in different natural ecosystems of theforests, grasslands, woodlands, wetlands, in field margins a nd garden fences, as weeds and inmany other microhabitats from where they are harvested when the need arises. These are freeaccess resources to all who want to use them for practicing traditional medicine or for sales.
Today, as many as 80% of the world’s people depend on traditional medicine for their primary
health care needs, according to the World Health Organization(WHO). The greater part of
traditional therapy involves the use of plant extracts or their active principles.
The preliminary results of a study on behalf of WHO has shown that the number of individuals
using medicinal plants is large and on the increase, even among young people. It is not just in
developing countries that medicinal plants are important. In the USA, for example, 25% of allprescriptions from community pharmacies between 1959 and 1980 contained materials fromhigher plants.
As harvesting of natural resources is an economic activity recognized both locally andinternationally, the use and commercialization of traditional me dicinal plants can improveincome and living standards in developing countries where rural people are economicallyvulnerable. As far as SMEs are concerned, both national and international trades in thiscategory are affected by the standardization of medicinal plants, because standardized
products are more welcomed by consumers and comparing with other products, they are taken
more confidently.
In the absence of regulatory control, product quality is too variable to accept. Inadequate post harvest storage and processing techniques often lead to high levels of biological/no biologicalcontamination and significant stock/losses. Little attention is paid to product packaging andmarketing, and the most significant value-adding takes place when the remedies areprescribed. Consumers’ safety is also an issue, although largely unmonitored at present. On theother hand, implementing such technical committees and new standard development will resultin market expansion, valid analytical methods for researchers and t he authorities, composition
and active component uniformity and a value added product for the industries, in addition toprotecting health and preventing commercial fraud .
An expression of commitment from the proposer to provide the committee secretariat if theproposal succeeds.
ISIRI is willingly to undertake the secretariat work of “Medicinal Plants Technical Committee”
when the proposal is accepted by ISO .

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Purpose and justification for the proposal. (The purpose and justification for the creation ofa new technical committee shall be made clear and the need for standardization in this fieldshall be justified. Clause C.4.13.3 of Annex C of the ISO/IEC Directives, Part 1 contains amenu of suggestions or ideas for possible documentation to support and purpose andjustification of proposals. Proposers should consider these suggestions, but they are notlimited to them, nor are they required to comply strictly w ith them. What is most important isthat proposers develop and provide purpose and justification information that is mostrelevant to their proposals and that makes a substantial business case for the market
relevance and the need for their proposals. Thorough, well-developed and robust purpose
and justification documentation will lead to more informed consideration of proposals andultimately their possible success in the ISO IEC system.)
Medicinal plants have been used in treating human diseases for thous ands of years. It appears that
Neanderthal man (about 60,000 years ago) valued plants as medicinal agents; this conclusion isbased on a grave in Iran in which pollen grains of eight medicinal plants were found (Solecki andShanidar, 1975). With the constant increase in the use of herbal medicines worldwide and the rapid
expansion of the global market, the safety and quality of herbal materials and finished herbal
products have become a major concern for health authorities, pharmaceutical industries and thepublic. The safety and efficacy of herbal medicines largely depend on their quality. Requirements
and methods for quality control of finished herbal products, particularly for combining/mixing herbal
products, are far more complex than for chemical drugs. The quality of finished herbal products isalso influenced by the quality of the raw materials used.
The latest World Health Assembly resolution on traditional medicine (WHA56.31) requested WHO toprovide technical support to develop methodology to monito r or ensure the quality, efficacy andsafety of products. In answer to WHO’s call, health authorities in developing countries have decided
to take traditional medicine more seriously and to explore the possibility of utilizing them in primary
health care. The quality of herbal medicines can directly affect their safety and efficacy.
Member States face complicated technical issues in the quality control of herbal medicines. In orderto promote and improve the quality of herbal medicines and also to reduce the proportion of adverse
events attributable to the poor quality of herbal medicines, WHO has committed to the developmentof a series of technical guidelines related to quality assurance and control of herbal medicines, aswell as to updating existing guidelines.
It appears to the health authorities that defining medicinal plants from cultivation to end product(both dried and liquid extracts using different solvent composition), tablet has a great necessity.
Monitoring and surveillance of the promotion of the use of medicinal plants is another issue thatneeds upstream documentation which will be achieve by implementing this committee anddeveloping the standard protocols(even developing a comprehensive document on medicinalplants). To promote traditional use of medicinal plants based on the latest scientific findings aboutsuch plants, transferring the technologies and developed countries are other benefits of theproposed deliverables. Theorizing and future frontiers of knowledge in all aspects of plant medicine
and aromatic plants will be achieved through this technical committee.
Unlike conventional pharmaceutical products, which are usually produced from synthetic materials
by means of reproducible manufacturing techniques and procedures, medicin al plants are preparedfrom materials of herbal origin, which are often obtained from varied geographical and/or commercial
sources. As a result it may not always be possible to ascertain the conditions to which they may
have been subjected. In addition, they may vary in composition and properties.
The list of the experts whose disciplines can contribute most to the conservation and utilization of
medicinal plants as follows:
To improve techniques for cultivating medicinal plants;
To persuade the public of the need to conserve medicinal plants;
To understand the ecosystems in which medicinal plants grow ;To identify the use of plants as medicines in traditional societies ;To include conservation and utilization of medicinal plants in their policy and planning;
To cultivate medicinal plants;
To develop effective legal mechanisms that ensure that collection of medicinal plants is at levels;
To study the application of medicinal plants;
To evaluate the patterns of use and the economic values of medicinal plants ;To understand the germination and storage requirements of the seed of different medicinal ;To protect the cultivated medicinal plants from pests and diseases without using dangerous ;To identify the medicinal plants accurately;
To provide information on the uses and availability of medicinal plants.
The economic and industrial environment in the medicinal plants field is changing, since due toeconomic requirements their production is moving to less developed countries, while quality control
and consumption occur in more developed ones. Moreover, it should be considered that markets
tend to globalization and dropping of some trade barriers. In this respect, the new committee
contributes greatly, by developing International Standardization of methods of analysi s andspecifications, to facilitate trade and commercial exchanges in the Medicinal plants sector, as theabove mentioned globalization has involved a growing demand of International standards on
medicinal plants.
Note: The scope and deliverables of this proposal aim at specific work of medicinal plants characterizations and do
not overlap or conflict with any scope or deliverables of ISO/IEC committees.
FORM 1 – Proposal for a new field of technical activity
Version 01/2015

Signature of the proposer
ISIRI

Further information to assist with understanding the requirements for the items above can be foundin the Directives, Part 1, Annex C.

FORM 1 – Proposal for a new field of technical activity
Version 01/2015