Separate Registration Requirements for New Botanic Ingredients Issued in China

10 Nov2015, CFDA invite public comments on the draft registration requirements for the new botanic ingredients. Any opinions shall be sent to 010-88330729 by fax or sent to cosmetic registration department of CFDA. The electronic versionshould be sent to hzpc@cfda.gov.cn by email as well before Dec 10, 2015.

Background

China is one of the earliest country using natural plants in food and drug. Recently, more and more plant materials are going to be applied in cosmetics. The finalized IECIC (Inventory of Existing Cosmetic Ingredients in China) published by CFDA (China Food and Drug Administration) on 30 Jun 2014 only includes thousands of plant cosmetic ingredients. Nevertheless, there are still large amounts of new plant cosmetic ingredients out of this inventory. As we know, all kinds of new cosmetic ingredients should be registered according to the Guidelines on the Registration and Assessment of New Cosmetic Ingredients (GUIDELINES) issued in 2011. Recently, CFDA reissuedthe Cosmetics Supervision and Administration Regulationsfor public opinions on 20 Jul 2015. One of the most important issues is new cosmetic ingredients will be managed depending on the level of safety risk.

Main contents

l Definition of new plants cosmetic ingredients

Natural plant-derived raw materials including algae have never been used in cosmetics in China, except the mono-substance or high purified substance extracted from plants.

l Nomenclature

• Standard Chinese name (reference: Inventory of Standard Chinese Name of International Cosmetic Ingredients(INCI 2010)or Nomenclature of Standard Chinese Name).
• Latin name and usage position.
• Medical effectbanned to be claimed as the function of cosmetic ingredients.

l Required toxicology data and exemptions.

In general, the following toxicology data is required.

1. acute oral or dermal toxicity; (originally “and”used)

2. skin and eye irritation/corrosion;

3. skinsensitisation;

4. skinphototoxicity and photosensitivity (required if the ingredient is used as UV-filters);

5. mutagenicity (should at least include a gene mutation test and a chromosome aberrationtest);

6. sub-chronic oral or dermal toxicity; (originally “and”used)

7. teratogenicity;

8. chronic toxicity/carcinogenicity

Table 1 Exemption criteriaand test requirements for the registration of new plant cosmetic ingredient

Exemption criteria		Required test items
Completely new at home and abroad	(1) Used as preservatives, colorants, hair dyes, sunscreen agents, whitening agents and other high safety risk new ingredients used for special use.	1,2,3,4,5,6,7,8
	(2)Not used as preservatives, colorants, hair dyes, sunscreen agents, whitening agents and other high safety risk new ingredients used for special use.	1,2,3,4,5,6
	(3) The ingredient has met criteria (2) and there is adequate proof indicating the ingredient has safety edible history more than 5 years.	2,3,4
	(4) The ingredient has met criteria (2) +(3) and theproduction process is different with other traditional edible ingredients.	1,2,3,4,5,6
Only new in China	(5) The ingredient has met criteria (1) and there is adequate proof indicating that new plant ingredient is safe to be used in cosmetics sold abroad for more than 5 years	2,3,4,5
	(6)The ingredient has met criteria (2) and there is adequate proof indicating that new plant ingredient is safe to be used in cosmetics sold abroad for more than 5 years	2,3,4
	(7) The ingredient has met criteria (2) and an official conclusion of safety risk assessment issued by foreign authority indicates the new plant ingredient is safety to be used in cosmetics.*	n/a

* Both the safety risk assessment report and conclusion have to be submitted. The toxicological test methods, evaluation items and methods have to comply with the Chinese cosmetic regulations .

l How to judge whether a plant ingredient has a safety edible history?

• Getting food safety or another kind of certification issued by competent authority. Or
• Being edible and/or pharmaceutic ingredients approved by domestic or overseas competent authority, technical institution or other authoritative organization

CIRS comments

• It is really a good news for all plant ingredient suppliers. More waiving conditions and less toxicology data will be available for the registration of new botanic ingredients. However, it is not available to a mono-substance or high

purified substance extracted from the plant.

• Compared with the earlier GUIDELINES (2011), the required toxicology data is a bit different.For both the acute and sub-chronic toxicity, it is optional to test via oral or dermal. Moreover, the toxicokinetics test is not required.
• The exempt conditions can be summarized as follows:

- Whether the new plant ingredientis new in other countries

- Whether the new plant ingredient is regarded as high safety risk substance

- Whether the new plant ingredient has been used in food safely for many years

- Whether the new plant ingredient has been used in cosmetics sold abroad safely for many years

- Whether the safety of the new plant ingredient is evaluated by foreign authorities

• A self-declaration issued by the applicant will be not accepted to prove the notified ingredient is safe to be used in food

Source: http://w ww.sda.gov.cn/WS01/CL0781/134400.html