Pharmabiz
 

Recent developments in the area of 'naturals'

Dr. DB Anantha NarayanaWednesday, February 15, 2012, 08:00 Hrs  [IST]

It is a fact that more and more consumers want to go back to nature and the preference to buy products which are natural or organic is increasing. The term natural is not very clearly defined as on date in any guideline or regulations. In Asian countries, consumers are more aware of the term herbs or herbals which are a subset of naturals. While all naturals may not be herbals, all herbals will be natural. The dictionary meaning of natural would be “made up of, derived from, and originating from, anything that is available in nature”. However, the need for clarity on this term when used with products more so with cosmetic product has gained wide attention. A common complaint on this area about a decade back used to be that information on herbals/naturals are scanty, not easy to find, many of which even if available are not fully scientific and reliable. However, the last decade has seen a lot of progress and developments in making more credible and scientific information available. This has been made possible by efforts of govt, national labs, academicians, and industrial research organizations.

In 2010, International Organization for Standardization (ISO) took up a new project and constituted a working group namely ISO/TC 217/WG4. This working group is preparing an International Standard for “Definition, Terminologies, and Criteria for Natural and Organic Cosmetics”. This working group has so far met four times, the last of the meeting was held at Paris on 18th March 2011. This working group is preparing two documents:

Definition, terminologies, and criteria for natural and organic cosmetics.

A base document (benchmark document or technical report) documenting available information on the above subject from various countries, listing and reviewing any guideline, provisions, agreements etc. whether mandatory or non-mandatory, whether prepared by any govt or semi-govt or even industry bodies or scientific associations. This document/technical report will serve as a basis on which the main international standard on the subject will be drafted apart from keeping in mind the current scientific, technological and understanding of the area.

The author of this article is a nominee of India through Bureau of Indian Standards (BIS) on this working group and has been attending face-to-face all the meetings of the working group and contributing to the development of the International Standard.  The initial working document prepared by the European Cosmetic Association (COLIPA) was circulated by the author to members of ISTMA (Indian Soap & Toiletry Manufacturer’s Association) and also to the members of the Cosmetics Sectional Committee, PCD-19 of Bureau of Indian Standards (BIS). Based on inputs obtained from them and the author’s own inputs due to the expertise on herbals area, have been submitted to ISO/ TC 217/ WG4, and in the formats provided by ISO.

Developments related to herbals/naturals
In addition to the above, various other developments have taken place in the last one decade related to herbals/naturals. Some of them are listed below:

    * Another working group of ISO is developing a technical report for essential and aromatic oils.
    * An ISO:19235:1997 exists related to Natural Raw Materials - Vocabulary which primarily aimed at aromatic plant materials and produces.
    * A new work introduction process has begun and is in the voting stage for preparing an ISO standard on “Testing for Heavy Metals in Cosmetics”. Indian Standards have already covered the method for determination of heavy metals.
    * CTFA, New Zealand, has already published a document on “Guidelines for Green Cosmetics Advertisement Claims for Cosmetics in New Zealand”, 2008.
    * BIS has already published a standard, IS 15735:2006, “General Guidelines on Herbal Cosmetics”.
    * A number of organizations have undertaken highly scientific work to develop quality specifications for herbs, processed herbs and herbal products. This development is very noteworthy as they provide a reference point providing technical descriptions, tests, methods to perform the test and the acceptable tolerance limits.  This has reduced conflict between buyer and seller, provided quality specifications when naturals are used either for preparing a supplement, or a food product or a medicine or for use in cosmetics. A few of such publications where either extensive data based monographs are published or quality specifications are published, are given below:

a.  Indian Pharmacopoeia Commission, which is entrusted with the objective of laying down standards for drugs & pharmaceuticals have a committee to develop quality monographs on herbals. 89 such monographs providing objectively available quality specifications for raw herbs, herbal extracts, processed herbs and few herbal products have been published in Indian Pharmacopoeia 2010.

b.  US Pharmacopoeia has introduced more than 160 quality monographs on herbals. Such monographs providing objectively available quality specifications for raw herbs, powdered herbs and extracts, processed herbs and few herbal products have been published in latest USP.

c.   British Pharmacopoeia has introduced more than 50 quality monographs on herbals.  Such monographs providing objectively available quality specifications for raw herbs, powdered herbs and extracts, processed herbs and few herbal products have been published in latest BP.

d.    The ICMR has been sphere heading efforts in the same area and as on date have brought out 8 volumes of “Quality Standards & Monographs for Indian Medicinal Plants). This publication is highly valuable as it provides scientific information on many aspects of Indian medicinal plants including photographs, TLC profiles, chromatograms and structures of compound and testing method for each of the plant listed. These plants find use across the spectrum of food, supplements, medicines as well as cosmetics. More than 200 plants have been covered in these volumes.

e.     Ayurvedic Pharmacopoeia of India has also brought out 8 volumes of API which provide quality specifications for more than 300 commonly used medicinal plants that find references in Ayurveda.

f.     Many years ago IDMA brought out “Indian Herbal Pharmacopeia” containing 52 monographs raw herbs.

Concurrently, India is known to be a biodiversity hot spot, large number of medicinal plants and botanicals are available in wild as well as from cultivated sources. The natural products industry that provides quality herbs and herbal extracts which are standardized has also grown and it is estimated that more than Rs.1200 crore worth of herbs and extracts are produced and exported in India. Similarly the aromatic and essential oil growing of plants, extraction of oils, fractionation of these oils, and production of pure compounds from the essential oils is also a leading industry. High quality aromatic oils and aromatic compounds, and oleoresins are produced in India and exported for use in fragrance and flavour industry. India has about 8 to 9% of global market in this area and about Rs 1500 cr turnover. The cosmetic industry in India has a total turnover of Rs 22,307 cr in 2009, out of which cosmetics making natural or herbal claims are increasing.

It is to be recognized that unlike BIS Technical Committees which operate on a consensus approach, ISO operates in a democratic way and puts to vote any issue which may have more than one opinion and no consensus. The decision based on majority vote would be taken forward.

It is important that technical representatives from India take adequate interest and provide timely technical inputs in the development of any standards/guidelines and work closely with and through BIS.

The author feels that as of today, representation and participation in these standards bodies and their work is rather low, and this may impact on acceptability, of Indian herbs/extracts/products, trade, commerce, as also possibility of sophisticated test methods being prescribed. It is also known that limits for contaminants like heavy metals are not uniform across geographies for herbals/traditional medicines, and ISO  can be a suitable place to try and get harmonized standards developed. Industries involved in herbals need to play a proactive role.

(Author is chairman of Herbal Products & Crude Drugs Committee of the Scientific Body of Indian Pharmacopoeia Commission)

 
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