National Pharmaceutical Control Bureau Ministry of Health, Malaysia

1. SURVEILLANCE OF COSMETICS National Pharmaceutical Control Bureau Ministry of Health, Malaysia

2. SURVEILLANCE Involves • Monitoring the SAFETY • Checking the QUALITY • Ensuring COMPLIANCE to allowable claims, labeling requirements Cosmetic Seminar 2001

3. SURVEILLANCE JOINT RESPONSIBILITY of the • Cosmetic industry and • the regulatory authority to monitor and ensure the quality and safety of cosmetics which are available for sale on the market Cosmetic Seminar 2001

4. SURVEILLANCE Generally carried out through: • Investigation of product complaints • Monitoring adverse reactions • Selective surveillance of marketed products Cosmetic Seminar 2001

5. SURVEILLANCE BY DCA Unlike the monitoring and surveillance of pharmaceuticals, the role of the regulatory authority for cosmetics will be mainly investigative when an adverse reaction or a product complaint is received. Active surveillance will be minimal. Cosmetic Seminar 2001

6. Quality & Safety Issues • Ingredients used in cosmetics should be within acceptable levels • Free of all hazardous/ prohibited ingredients • Cosmetics need not be sterile but must be free of contamination with pathogenic microorganisms & the density of non-pathogenic microorganisms must be low Cosmetic Seminar 2001

7. Cosmetic Safety • Almost all cosmetics can cause allergy in certain individuals • Today, serious injury from cosmetics is a rare event but, it still can happen • USFDA survey - almost 25% of people questioned had an allergic reaction to personal care products Cosmetic Seminar 2001

8. Safety Issues Safety of products can be established through • Monitoring of adverse reactions • Testing to ensure contents are within allowable limits and product is free of contaminants Cosmetic Seminar 2001

9. COSMETIC SAFETY Largely dependent on: • Contents • Quality of the finished products • Attitude of the cosmetic industry • Consumer education Cosmetic Seminar 2001

10. Surveillance of Cosmetics Report received by DCA/industry Identify nature of problem Adverse reaction report? Product defect?

11. Adverse Reactions Monitoring Consumers will be encouraged to report adverse reactions through health professionals rather than directly to the DCA but consumer reports will be entertained for cosmetics Cosmetic Seminar 2001

12. Adverse Reactions Monitoring On receiving an adverse reaction report, the DCA will need to ascertain whether it is : • an isolated allergic reaction due to the consumer’s reaction to ingredients in a product, or • a product related problem Cosmetic Seminar 2001

13. Adverse Reactions Monitoring In the case of an allergic reaction • regulators will take note of such reports • Individual consumers should be educated to avoid the use of such products in future. Cosmetic Seminar 2001

14. ADVERSE REACTION REPORT Isolated Allergic Reaction Cluster of similar reports Attempt to identify possible causative agent Attempt to identify possible causative agent Implement precautionary action eg warning labels, restrict usage, withdraw product Enter intodatabase

15. PRODUCT DEFECTS Can occur due to • Manufacturing problems • Transportation • Storage Cosmetic Seminar 2001

16. PRODUCT DEFECT Non- serious/ Minor Product Defect Serious/ Major Product Defect Complaint forwarded to registration holder Investigation conducted by DCA Industry implement corrective action

17. PRODUCT COMPLAINTS - Role of the DCA • When a product complaint is received by the DCA, nature of the problem will be studied. • Minor product defects - complaint will be channeled to the registration holder for their action Cosmetic Seminar 2001

18. PRODUCT COMPLAINTS - Role of the DCA • Serious defects - DCA will conduct its own investigations which may include laboratory testing to ensure compliance to accepted specifications • Products found to be adulterated or containing prohibited substances may face deregistration Cosmetic Seminar 2001

19. Surveillance by DCA Sample collection for examination/analysis based on complaints, suspicion • Follow-up on product complaints • Random inspection to ensure compliance to labelling, packaging, etc. • Removal of adulterated and misbranded products from the market Cosmetic Seminar 2001

20. PRODUCT COMPLAINTS - Role of the DCA • Products found not to be in compliance with acceptable standards - DCA may instruct for a product/batch recall to be done within a stipulated time. • Degree and level of recall will depend on the nature and severity of the problem identified. Cosmetic Seminar 2001

21. FORMS OF PUNITIVE ACTION • If a product is found to contain • adulterants • scheduled poisons • does not comply to limits stipulated in CIR • the DCA can take punitive action such as • instruct a batch/product recall • deregisteration • institute court action with the help of pharmacy • enforcement Cosmetic Seminar 2001

22. Surveillance by the Industry • Surveillance of products in the market especially close to “expiry date” • Random inspection of goods received to ensure compliance to labelling, packaging • Customer satisfaction surveys Cosmetic Seminar 2001

23. Responsibility of the Industry The industry should be responsible enough to impose self-regulation upon itself and to remove substandard or defective products as fast as possible from the market. Cosmetic Seminar 2001

24. PRODUCT RECALLS Product recalls are actions taken by the industry to call back products or batches that present a hazard or are somehow defective Cosmetic Seminar 2001

25. DEGREE OF RECALL • Degree I : Within 24 hours • - usually associated with a serious • safety issue • Degree II: Within 72 hours • - also associated with a safety issue • with a lower risk potential • Degree III: Within 30 days • - due to a product defect Cosmetic Seminar 2001

26. LEVEL OF RECALL • Level A: Up to consumer level • Level B: Up to distributor level • Level C: Up to wholesaler level • Level D: Up to manufacturer/importer’s level Cosmetic Seminar 2001

27. BATCH RECALL PROCEDURE DEFECTIVE PRODUCT -risk to consumers DECISION TO RECALL** 1. Voluntarily by registration holder 2. On DCA’s instruction

28. Information required: i. Quantity manufactured/ imported ii. Quantity sold iii.Quantity in-stock iv. List of purchasers EMBARGO UNSOLD STOCKS PREPARE LIST OF NAMES AND ADDRESSES OF WHOLESALERS/ RETAILERS SUPPLIED WITH BATCH UNDER RECALL REGISTRATION HOLDER PREPARES AND SENDS OUT RECALL LETTERS

29. ARRANGE TO COLLECT BACK ALL STOCKS UNDER RECALL FROM WHOLESALERS/ RETAILERS SEGREGATE ALL RECALLED STOCKS DESTROY AFFECTED STOCKS SEND REPORT TO DCA

30. RECORD KEEPING • The DCA will have the authority to check on investigational methods and recall procedures instituted by the industry. • To facilitate this, industry must keep proper records of all product complaints, adverse reactions and investigations which were done. Cosmetic Seminar 2001

31. SURVEILLANCE -ROLE OF THE INDUSTRY It would be in the interest of the company to set up a department to conduct • surveillance of marketed products • investigate product complaints • identify & rectify product shortcomings • oversee product recalls • monitor adverse reactions Cosmetic Seminar 2001

32. INFORMATION SHARING ADR INDUSTRY REGULATORS PRODUCT COMPLAINTS IMPROVE QUALITY & SAFETY OF MARKETED PRODUCTS Cosmetic Seminar 2001

33. CONCLUSION The registration holder will have the ultimate responsibility of ensuring that all cosmetics available for use in the market are safe for their intended use and meet the quality standards which are expected of it. Cosmetic Seminar 2001