Workshop on the Guidelines for the Safety Assessment of a Cosmetic Product

The workshop on the Guidelines for the Safety Assessment of a Cosmetic Product was held in Siem Reap, Cambodia on 12 – 13 June, 2006.

The draft of the guidelines was presented to the meeting and finalized with minimal amendments. Key points of the guidelines are as follows:

1. Objective and general approach
• Product safety under normal and reasonably foreseeable conditions of use is of top priority
• The main purpose of the guidelines is:
(a) to help the industry assess the safety of their products
(b) to help the authorities audit the data in the product information files
(c) to highlight important considerations in the safety assessment process

2. Main concerns
• Skin irritation & sensitization for all products, and
• Photo-irritation & photo-sensitization for products used when sun exposure is possible
• Eye tolerance for products used on the face and scalp, and
• Systemic toxicity of product via percutaneous absorption and/or ingestion

3. Approach
• Major basis is the toxicity profile of the ingredients, together with local tolerance of the finished product
• Other important aspects include application of cosmetic GMP, adequate packaging, QC, appropriate labeling, adequate processes for handling & management of consumer complaints, management of product changes and corrective action for adulteration.
• Finished product toxicity tests on animals is not necessary, nor is it recommended

4. Ingredients
• Careful selection on ingredients is critical
• Important points to note include raw material impurities, interactions between ingredients, the potentiation of skin penetration and exposure conditions
• Ingredients need to comply with current legislative requirements and those with insufficient/incompatible data or not properly characterized should be avoided
• The main source of toxicity data for ingredients should be the supplier. There are times when additional testing by the supplier need to be conducted. Additional data can also be obtained via public literature
• For fragrances, a safety evaluation by the supplier together with certification declaring conformity to current IFRA guidelines should suffice
• Ingredients listed in Annex III to VI do not need supporting data if used within conditions specified in the Directive

5. Safety assessment of Products
• Safety assessment of products is related to the manner of use and is based on the properties the ingredients, interpreted with consideration of human exposure
• For new products which are simple variants of existing products or are using existing raw materials at the same level in the same type of products, probably no additional data is required
• However, new and/or additional data would be required for new ingredients or existing ingredients used in new ways
• Local tolerance testing of the finished formulation is necessary when data on ingredients is not enough to define local tolerance
• Tolerance testing on humans is to be conducted under Good Clinical Practice

6. Safety claims
For example, dermatologist tested, ophthalmologist tested:
• These claims need to be supported by evidence from human testing of the finished product
• Testing needs to be conducted ethically and pre-test safety evaluation is necessary

7. Safety Assessor responsibilities
• The safety assessor is responsible for making sure that legislative requirements are met, all necessary endpoints have been considered and that data is relevant and sufficient. He/she will also need to consider if ingredient interactions or potentiation of penetration will occur and also if complementary data is required
• There should be close collaboration between assessor and formulator so that requirements are met while the formulating process occurs
• All information on the ingredients and the formulation should be made accessible by the suppliers and formulators to the assessor
• The safety assessor needs to be qualified in a relevant field and be suitably trained in cosmetic safety assessment
• He/she should not have involvement in commercial aspects of the product
• Recommendations of the safety assessor has to be followed, e.g. product cannot be marketed if assessor concludes that the product cannot be marketed safely
• This recommendation signed by the Safety Assessor is to form part of the safety statement in the product information file
• The meeting also clarified that
(a) The selection of a suitable safety assessor is the responsibility of the manufacturer and as such, a wrong assessment made by the assessor is the responsibility of the manufacturer
(b) However, safety concerns with a product will be the responsibility of the company placing the product in the local market
(c) The product information file is to contain a safety assessment/statement and a copy of the safety assessor’s qualifications

8. Raw material supplier responsibilities
• To provide customers with adequate information regarding safety of the ingredient supplied
• Type of information required for chemicals, botanical extracts and ingredients of animal origin are also lined out, e.g. pesticide levels and identification of plant/part for botanical extracts, declaration on absence of TSE and identification of animal/part for materials of animal origin

9. Manufacturer, distributor and regulator responsibilities
The meeting also agreed to make the following recommendations to the ASEAN Cosmetic Committee
• To adopt the safety evaluation
• To disseminate the guidelines to regulators & industry via training seminars
• To create a curriculum, including examinations, for the training of industry and authority safety assessors and to involve the ASEAN Cosmetic Scientific Body in the preparation of the training modules and examination
• To look into involving institutions of higher learning for the longer term

The ASEAN Member States will go through the guidelines and recommendations before they are finalized at the next ACC meeting in December 2006.

RM supplier Responsibilities
Chemical
Physical/ chemical/ micro specifications, purity
Absence of Annex II ingredients
Tox data (acute tox, dermal absorption, skin & eye irritation, mucus membrane irritation (if applicable), skin sensitization, subchronic tox, mutagenicity, phototox, photomutagenicity (if applicable), human data (if available)

Botanical extracts
Physical/ chemical/ microb specifications, purity,
Pesticide levels, proper identification of plant & parts used
Tox data

Material of animal origin
Physical/ chemical/ microb specifications, purity,
Proper identification of plant & parts used
Absence of TSE & Annex II ingredients beyond unavoidable traces e.g. hormones

Tox data

4th meeting of the ASEAN Cosmetic Scientific Committee (ACSB)

The meeting was held on June 14, 2006 in Siem Reap Cambodia.

A review of ingredients in the ASEAN Handbook of Cosmetic Ingredients was conducted. The results of the review include recommendations to

Review of Azelaic Acid, Tranexamic Acid, Dichloromethane, Thiolactic Acid, Henna and Ethyl-4-[bis(hydroxypropyl)]aminobenzoate were not finalized and will be further discussed at the next meeting when additional information is available.

A proposal made by Singapore to regulate hydrogen peroxide for home-use tooth whitening products at a maximum permissible level of 6% was accepted and would be implemented for 12 months to enable member states to evaluate market impact. Singapore was also tasked to develop a proposal for the regulation of hydrogen peroxide in tooth whitening products at levels over 6%, for use by dentists only.

Thailand reported that the ASEAN fluoride workshop was for the Thai limit for fluoride in oral care products to remain as 1100ppm, due to high fluoride in the local water supply. Thailand also proposed that the ASEAN limits in the Directive be lowered from the current 1500ppm to 1100ppm, citing high occurrence of fluorosis in ASEAN in general. ACSB members are to consult their local dental associations for input for further discussion at the next meeting.

The microbial test limits proposed by the ASEAN Cosmetic Association (ACA) as follows was also accepted.

* In talc and herbal products only

The ACSB also agreed to propose to the ACC that ACSB would form a team to come up with a list containing examples of non-permissible cosmetic claims. The ACC later tasked the ACSB to do so.

The ACSB will also work to issue an updated version of the ACD Annexes, which would include all changes approved by the ACC. All ingredients will also be rearranged in alphabetical order of their INCI names.

The ACC accepted and approved the ACSB proposals.

6th meeting of the ASEAN Cosmetic Committee

The meeting took place on 15 - 16 June 2006 in Siem Reap Cambodia. Highlights of the meeting are as follows.

Follow up from the 27th ACCSQ meeting

ASEAN and China are working actively towards the establishment of a Free Trade Area (FTA) by 2010. ASEAN has expressed interest in technical cooperation for the healthcare sector, specifically for Traditional Chinese Medicine, Cosmetics and Health Supplements.

FTAs’ with Japan, India, Korea, Australia and New Zealand are also in negotiation.

Report of the Good Regulatory Workshop

The workshop was held in March 2006 in Jakarta Indonesia. Main discussions included GMP implementation in the context of the ASEAN Cosmetic Directive (ACD) and the classification of borderline products.

Where GMP implementation is concerned, the ACD states that all cosmetic products introduced into the ASEAN market needs to comply with the ASEAN Cosmetic GMP Guidelines and that self-declaration by the manufacturer is allowed. Some issues raised at the workshop were the impact on imported products and if GMP equivalency will be considered.

The ACC agreed for the GMP Task Force to consider this issue and to present a proposal at the next meeting.

For borderline products, the concluding recommendations from the workshop were:

The ACC noted the recommendations and tasked the ACSB to discuss the above and make a proposal.

Implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme
All countries reported on the status for amendment of their national legislation to align with the ACD. Laos & Vietnam are working with a Transposition Project Group to draft the transposed regulations.
All countries have re-committed to implement the ACD by January 1, 2008.
Malaysia & Philippines have decided not to enter into Mutual Recognition Agreement.

Training projects under the external assistance
ASEAN was able to receive funding from the International Trade Centre (ITC). A series of regional, sub-regional and national trainings for cosmetic post-marketing surveillance have been carried out under this project. There will also be a series of regional and national GMP trainings carried out from July to November 2006.
GRP workshop funded by Australia was completed.
ASEAN was also able to receive funding from PTB Germany for further training activities. These have covered the Notification Workshop and the Safety Guidelines Workshop. Further workshops will be on PMS-SE and the finalization of the Safety Guidelines.

Post-Marketing Alert (PMA) System
Member states have agreed to implement the PMA system proposed by Singapore for a period of 1 year, with immediate effect. Amendments and improvements to the system will be discussed at the ACC meeting in June 2007 before formal adoption of the system.

Notification Template & Guidance Document
The finalized draft of the “Template for Notification of a Cosmetic Product” and the guidance document on product notification was adopted by the meeting.
Member states may choose if they would like to make the submission of the product ingredient list and packaging material mandatory in their country.
Questions were raised on whether cosmetic samples in hotels need to comply with the ACD. The meeting agreed that these samples would need to comply and as such be notified before launch on the local market.

The next meeting will be held in the 1st week of December 2006 in Philippines.