Presented by Nazarita T. Lanuza, R. Ph., M. M.

1. BANNED INGREDIENTS Presented by Nazarita T. Lanuza, R. Ph., M. M.

2. Banned Substances inCosmetic RegulationThe EU Example : History • Present Status • Benefit & draw-backs

3. The EU example: History Origin: * EU cosmetic Directive was compiled within years 1973~1976 and was finally adopted during 1976.* Legislators were inspired by rules governing food or pharmaceuticals. This led to a system partly based on the safety of ingredients involved in cosmetic products, and to the adoption of lists of substances.

4. The EU example: History Among these lists, the negative list has been defined as the list of substances that cannot be used in cosmetic products. NEGATIVE LIST = BANNED SUBSTANCES Reason:- The rational leading to the ban of substances in cosmetic products is based on safety consideration.

5. The EU Example: present status Banned ingredients consist of substances which when used in cosmetic products may be harmful for human health according to the present knowledge of science, and therefore cannot be part of the composition of cosmetic products.

6. The EU Example: present status Presence of traces of banned substances can be allowed provided it is technically unavoidable in GMP practice and it does not make the finished cosmetic product to cause damage to human health when applied under normal or reasonably foreseeable condition of use, taking into account product presentation, instruction for use or any other relevant instruction

7. The EU Example: present status Banned substances are decided by authorities on the basis of evaluation made by scientific experts and after discussion with interested bodies. • Decision should be based on the concept of risk to the consumer and not only on the hazard of substance.

8. The EU Example: present status Risk is related to Hazard through: Probability of Exposure and Dose Response Decision for banning a substance from its use in cosmetics should be established after an in depth evaluation of the toxicity of the substance.

9. The EU Example: Composition Negative list contains 451 substances. At the origin, the first 361 designated ingredients were selected from the French <<Table of Venenous substances >>, because of their specific use in pharmaceuticals. Recently added substances came from the deepening of the scientific knowledge on the toxicity of chemicals. (colouring agents, perfume ingredients, etc.)

10. The EU Example: Future Recent trends show that safety evaluation is more and more taking into account the chemical field in general and position cosmetics as elements derived from this field. Environmental factor enter into consideration. CMR substances banned in the Dangerous Chemical Substances Directive may all be added to the present negative list of the Cosmetic Directive regardless of any relevance to cosmetic products.

11. The EU Example: benefits and draw -backs Benefit:- Safety of consumers- Environment friendlyDraw-backs:- Growing complexity of the banned substances list leading to confusion and exaggerated restrictions

12. TOXIC EFFECTS OF HEAVY METALS Arsenic - is perhaps the most infamous poison to date.- Elemental arsenic is not toxic but other forms are extremely toxic- Paralysis of the extremities is symptomatic of chronic inorganic arsenic poisoning- Vascular disorder of the toes known as “blackfoot desease” (gangrane)- Can cause skin and lung cancer

13. TOXIC EFFECTS OF HEAVY METALS Cadmium– has incredibly long half in the body of 10-30 years.- Chronic exposure results notably in us accumulation in the kidney- First sign of poisoning is tubular proterenuria- Long exposure results in calcium metabolism, osteoporosis and osteomalacia

14. TOXIC EFFECTS OF HEAVY METALS Cadmium(cont. . .)- A single report of the chronic of the chronic effect comes from Toyoma Prefacture. The synchromone suffered was called Itai-Itai, translates as Ouch Ouch associated with painful cuts.- In extreme cases load-bearing bones of the skeleton suffered deformation, fracture and collapse

15. TOXIC EFFECTS OF HEAVY METALS Lead– in adults and children there are different profiles of inorganic lead toxicity. Children are more susceptible t lead.- Even low levels of lead can limit the (bodily) growth and intelligence of children- Gastrointestinal colic and anaemia

16. TOXIC EFFECTS OF HEAVY METALS Lead(cont. . . .)- Nephropathy, renal tubular disorder- Segmental demycolination of motor neutron i.e. wrist drop caused by pheripheral neuropathy

17. TOXIC EFFECTS OF HEAVY METALS Chromium– the known harmful effects of chromium in humans have been attributed to hexavalent form.- Renal tubular necroses- Chromium dusts cause lung cancer, ulceration and perforation of the nasal system

18. TOXIC EFFECTS OF HEAVY METALS Mercury– are not required for any specific biological function in living tissues.- Inhalation results in respiratory irritation and bronchitis- Ingestion of inorganic salts produce local GI tract neciosis and renal failure- Nephrotic sydrome is classical for chronic ingestion

19. TOXIC EFFECTS OF HEAVY METALS Mercury(cont. . . .)- “Minimata” victims had symptoms of: * numbness of fingers and lips * difficulty in hearing * impaired ability to walk and speak * tremon ad violent involuntary muscular convulsion * organic alkyl mercury salts are teratogenic

20. TOXIC EFFECTS OF HEAVY METALS Mercury(cont. . . .)- Prolonged allergic dermatitis- Prolonged use may cause local pigmentation of skin or eyelids- Absorption following vigorous dermal application has been reported with resulting ptyalism

21. TOXIC EFFECTS OF HEAVY METALS Mercury(cont. . . .)- Oral ingestion causes epigastric pain, nausea, purging

22. THANK YOU ! ! !