Standards Development

Scope

This document specifies minimum requirements and test methods for Carthamus tinctorius flower that is derived from Carthamus tinctorius L.

It is applicable to Carthamus tinctorius flower that is sold and used as Chinese materia medica.

Purpose

Carthamus tinctorius flower is traditionally used as a herbal medicine for menstrual problems, cardiovascular complications as well as pain and swelling in trauma cases for thousands of years. Carthamus tinctorius flower and its products are widely used around the world. At present, there are at least 60 countries producing or using this herb, with the planting area of around 1.1 million hectares each year. Among them, India, US, Mexico, China and Canada are the major producing countries. The planting area in China is around 50,000 hectares, with the yield of 3800~4500 tons per year. Safflower is also in the top 100 prioritized list of single herbal medicines in ISO/TR23975:2019 based on its great trade volume and record in the pharmacopoeias of over 5 countries/regions. An ISO standard is needed to ensure the quality, safety and the commerce in global markets of Carthamus tinctorius flower. Reasons are given as follows: 1) Carthamus tinctorius flower is widely cultivated or produced worldwide, of which the quality is varied significantly or unstable because of the differences in collection, sampling, processing, transportation and storage methods among different areas. 2) Due to its great demand, trade in Carthamus tinctorius flower has been complicated by adulteration and substitution. For example, the sands, saline or sugar water has been added in the flowers to gain the weight for sale. Some stains are even used to make its color brighter. 3) There are over 5 countries or regions establishing the quality standard for Carthamus tinctorius flower. But the identification indicators, types and limits of marker constituent, and test methods are varied, which makes the trade barriers hard to eliminate. 4) For more than 50 countries using the herb whereas lacking a national standard to follow, an international standard of Carthamus tinctorius flower would be beneficial for those countries to refer. Along with the expansion of Carthamus tinctorius flower in the global market, the establishment of an international standard for it is therefore necessary to support the quality consistency, clinical effectiveness and safety in international trade