COSMETIC INGREDIENTS & PRODUCT SAFETY

Transcription

1 WHO Collaborating Centre for Regulatory Control of Pharmaceuticals COSMETIC INGREDIENTS & PRODUCT SAFETY Penang International Halal Expo & Conference 2012 Member of Pharmaceutical Inspection Cooperation Scheme Certified to ISO 9001:2008 Cert. No: AR 2293 ZURAIDA ABDULLAH Biro Pengawalan Farmaseutikal Kebangsaan Kementerian Kesihatan Malaysia Jalan Universiti Petaling Jaya, Selangor Tel : Fax : Website :

2 Presentation Outline Introduction Cosmetic Ingredients Approach on Product Safety 2

3 Definition A cosmetic product shall mean : any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition 3

4 Regulation of Cosmetics in Malaysia (1) Cosmetics are regulated under the Sale of Drugs Act 1952 (Revised 1989) and the Control of Drugs and Cosmetics Regulations 1984 (amendment 2009) No person shall manufacture, sell, supply, import or possess any cosmetic unless the cosmetic is a notified cosmetic. The person responsible for placing the notified cosmetic in the market shall comply to any directives or guidelines issued under regulation 29 and any conditions imposed by the Director of Pharmaceutical Services (DPS) 4

5 Regulation of Cosmetics in Malaysia (2) The company or person placing the product in the market must be responsible for ensuring safety, quality and claimed benefit of the cosmetic product placed in the local market and to ensure that the product complies with all existing regulations 5

6 Regulation of Cosmetics in Malaysia (3) Cosmetic Manufacturers need to ensure: - products are manufactured in facilities that comply with the ASEAN Guidelines on Good Manufacturing Practice (GMP) 6

7 Regulation of Cosmetics in Malaysia (4) No person shall possess or publish any label, information, pictorial, statement or document which describes the claim of the cosmetics otherwise than in the manner as determined in the directives or guidelines issued by the DPS. 7

8 Guidelines for Control of Cosmetic Products in Malaysia (1) The Guidelines comprises of : ASEAN Guidelines for Product Information File (PIF) ASEAN Guidelines for Safety Assessment of Cosmetic Product ASEAN Cosmetic Labeling Requirements ASEAN Cosmetic Claims Guidelines ASEAN Guidelines on Good Manufacturing Practice (GMP) for Cosmetic Guide Manual For Adverse Event Reporting Cosmetic Advertising Code 8

9 Guidelines for Control of Cosmetic Products in Malaysia (2) Ingredients Annexes Annex II : List of Substances Which Must Not Form Part of The Composition of Cosmetic Products Annex III : List of Substances that Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down Annex IV : List of Colouring Agents Allowed for Use in Cosmetic Products Annex VI : List of Preservatives Allowed for Use in Cosmetic Products Annex VII : List of UV Filters which Cosmetic Products May Contain 9

10 Basic of product safety requirement must not cause damage to human health when applied under normal or reasonably foreseeable condition of use manufacturer has to gather the necessary technical information component & finished product evaluated for aspect of safety products produced under GMP safety data available labeling meets the labeling requirement

11 Ingredients (1) Cosmetics a mixture of ingredients Eg : colorants, preservatives, UV Filters, fragrance & etc Adopt EU Directives + ASEAN list Negative list Prohibited list (Annex II 1371) Restricted list Annex III part substances Annex III part 2 61 substances Positive list Annex IV (Colorants) -160 substances Annex VI (Preservatives) Annex VII (UV Filters) FOR MORE INFO... Guidelines for Control of Cosmetic product in Malaysia 11

12 Ingredients (2) To be avoided: Ingredients prohibited under Annex II Ingredients from Annex III when used beyond permissible use Ingredients with toxicological data incompatible with the intended concentration and use Ingredients which do not have sufficient toxicological data and/or safety in-use experience Ingredients which are not properly characterized either chemically or through the extraction process for naturals 12

13 Ingredients (3) Cosmetic product should be free from the ingredients listed in the poison list such as: Hydroquinone Tretinoin Theophylline Azelaic Acid Steroid (refer posion list:

14 Article 3 ASEAN Cosmetic Directive - Safety requirements A cosmetic product placed on the market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product s presentation, its labeling, instructions for its use and disposal, warning statements as well as any other indication or information provided by the manufacturer or his authorised agent or by any other person responsible for placing the product on the market 14

15 Cosmetic products have to be safe for: Consumers Professionals -e.g. hairdressers, beauticians

16 Main concern on safety: Skin irritation Skin sensitization Photo irritation/sensitization Eye tolerance Lip tolerance Systemic toxicity -e.g. percutaneous absorption, accidents (children), reasonably foreseeable intake (oral,lip)

17 CONSUMERS EXPECTATIONS (1) The cosmetics placed on the market are safe and free from banned substances/harmful ingredients i.e. Hydroquinone, Tretinoin, Theophylline, Azelaic Acid & Steroid To provide with adequate information on cosmetics for an informed choice and correct usage - Obtained from: Good labeled product Appropriate/substantiated cosmetic claims Proper packaging vs product packed in ampoule, vial, eye dropper bottle

18 CONSUMERS EXPECTATIONS (2) Product complaint Competent personnel to handle and entertain product compliant Provide a platform for them to lodge complaint Regulators & company to be proactive and responsive towards complaint

19 CONSUMERS EXPECTATIONS (3) Advertising - To provide them with reliable, accurate, truthful, informative, balanced, up to date information as well as capable of substantiated - Keep away from misleading or unverifiable statements/claims

20 HOW TO GET A SAFE PRODUCT? Sharing of full responsibilities 1. Raw material suppliers 2. Formulators 3. Manufacturers 4. Notification holder 5. Regulators

21 RAW MATERIAL SUPPLIER RESPONSIBILITIES (1) 1. Chemical -Provide adequate information as to safety of ingredients -Physical/chemical/microbiological specifications-purity 2. Botanical extracts - Provide adequate information as to the safety of the ingredients - Proper identification of the plant/part used - Physical/chemical/microbiological specifications-purity - Pesticide level - Toxicity studies e.g. Skin irritation, Photo toxicity, Mutagenicity

22 RAW MATERIAL SUPPLIER RESPONSIBILITIES (2) 3. Animal extracts -Proper identification of the animal/part used -Physical/chemical/microbiological specifications-purity -Absence of Transmissible Spongiform Encephalopathy (TSE) - Absence of banned ingredients beyond unavoidable traces (e.g. hormones, antibiotics, etc)

23 FORMULATOR RESPONSIBILITIES Select safe cosmetic ingredients Checking local tolerance of finished product Select appropriate packaging -maintain the quality -avoid risks of misuse or accident

24 MANUFACTURER RESPONSIBILITIES Comply to ASEAN Cosmetic GMP Quality control chemical microbiological Appropriate labeling presentation of the product instruction for use, warnings (if relevant) Adequate complaint/adr handling procedure

25 NOTIFICATION HOLDER RESPONSIBILITIES To ensure that manufacturer manufactures safe product -has good adequate system to ensure product safety -comply to ASEAN Cosmetic GMP requirements Collect information on post marketing experience and transfer such information to the manufacturer on a timely basis, determine trends and keep adequate records Competent personnel to handle product complaint and recall Report any Serious Adverse Event to the authorities

26 REGULATOR RESPONSIBILITIES To ensure public health and safety; -PMS activities; product sampling, PIF audit Good collaboration with industry -to investigate complaint/serious adverse events & take proper action To remove unsafe products from the market -product recalls, notification cancellation, media announcement

27 SAFETY ASSESSMENT (1) Raw material selection Safe Right concentration Impurities Ingredients interactions Packaging Product integrity Product quality Minimize misuse

28 SAFETY ASSESSMENT (2) ASEAN Cosmetic GMP Quality Control Chemical heavy metals, impurities Microbiological Appropriate labeling Complaint management Product post market surveillance Product Change (stability) Adulteration

29 PRODUCT SAFETY Under normal/reasonable use conditions - Safety of the ingredients depends on exposure conditions i.e.: Type of formulation Concentration Frequency Duration of contact Body area involved Effect of the sun Foreseeable misuse

30 PRODUCT SAFETY EVALUATION Safety evaluation of finished products Manner of use Absorbed through skin Absorbed through mucous membrane Ingested Inhaled Evaluation methods -i.e. in vitro testing, clinical (in vivo testing)

31 SAFETY ASSESSOR Must have relevant competency -Qualification, example, diploma in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline and be suitably trained in the safety assessment of cosmetics Knowledgeable in safety evaluation on cosmetics Responsible and ethical Need not be an employee of the company -i.e. Can belong to an external organization or institution

32 SAFETY ASSESSOR RESPONSIBILITIES Ensure product s compliance to ACD -e.g. Ingredients Data available Ingredients safety data Relevant Sufficient Interactions of toxicological relevance Penetration is likely to occur Complementary data are needed On-pack product claims Ingredients Finished product

33 SAFETY ASSESSOR JUDGEMENTS Should be based on: Knowledge & experience of ingredient toxicological properties Safety-in-use of the known ingredients History of safety-in-use of products containing the same or similar ingredients Expert judgment of the set of data available on an unknown, new or novel ingredient Results of additional data obtained either on one or more ingredients or on the finished product

34 POSSIBLE SAFETY ASSESSMENT RESULTS Product is safe, Without special warnings or precautions Provided a given type of packaging is used Provided a warning is added Mode of use and usage instructions are defined Provided a complementary test with favorable results is performed Product is not safe for proposed use Available data insufficient to determine the safe use of the product Further studies need to be carried out Specific safety claims may or may not be used

35 Conclusion Cosmetic ingredients are mostly chemicals and often mixtures of chemicals of synthetic origin or natural extracts. The careful selection of ingredients is the key issue for the product safety and efficacy. Ensuring the safety of a cosmetic product requires a global approach throughout the life of the product from the choice of raw materials to the marketing follow-up. 35

36 Thank you very much for your kind attention 36