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Comparison between EU and ASEAN Directives

Comparison between EU and ASEAN Directives. Simon Young Director of External Affairs Unilever Asia & Africa. Overview. Setting the scene Similarities Differences Summary. Setting the Scene. Europe. 76/768/EC has been in place for 29 years

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Comparison between EU and ASEAN Directives

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  1. Comparison between EU and ASEAN Directives Simon YoungDirector of External AffairsUnilever Asia & Africa

  2. Overview • Setting the scene • Similarities • Differences • Summary

  3. Setting the Scene

  4. Europe • 76/768/EC has been in place for 29 years • Has successfully regulated a multicultural, multilingual marketplace of 15 countries • Has been modified many times to reflect technical and cultural developments

  5. Europe • Is currently being extended into 10 new member countries as a pre-requisite to EU entry • Has formed the basis of an internationally-recognised approach now adopted in Latin America, South Africa and many other countries

  6. ASEAN • The ASEAN Harmonised Cosmetic Regulatory Scheme • An agreement to work together to ensure safe cosmetic products & to eliminate trade barriers • Signed by member governments on 2 September 2003 for implementation in 2008

  7. ASEAN • Schedule AThe ASEAN Mutual Recognition (of Product Approvals) Scheme (MRA) • Schedule BThe ASEAN Cosmetics Directive, based upon the learnings of the European Cosmetic Directive

  8. Similarities

  9. Similarities • Common aims • Common definition of scope • Common regulation of ingredients • Common approach to product safety • No pre-marketing approval process • Focus on in-market control • Scientific support processes • Data to be maintained

  10. Aims • To ensure safety of cosmetic products • To enable free trade of cosmetic products with no pre-marketing registration approval

  11. Any substance or preparation intended to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly for cleaningthem,perfuming them, changing theirappearance,and/or correcting body odours and/or protecting or keeping them in good condition Scope

  12. Illustrative List • Skin creams etc • Powders • Soaps • Perfumes • Depilatories • Deodorants and Antiperspirants • Sunbathing products • Sunless tanning products • Hair care products • Products for the care of the teeth & mouth • Skin-whitening products • Anti-wrinkle products • Shower & bath preparations • Lip products, etc.

  13. Ingredients • Annex II - The banned list • Annex III - The restricted list • Annex IV - Colourants positive list • Annex VI - Preservatives positive list • Annex VII - UV Filters positive list

  14. Product Safety A cosmetic product must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use

  15. Product Safety • Regulation should be underpinned by sound scientific opinion • International approach to safety assessment has been adopted • Scientific Committee trained by EU experts

  16. Pre-marketing Approval • Industry is responsible for assessing compliance with regulation prior to launch • No product pre-marketing approval by regulators is required

  17. In-market control • Product compliance is assessed by in-market control by regulatory bodies • In-market inspection is required to catch counterfeit and other non-conforming products • All products on the market may be inspected. Unethical companies cannot give one set of samples to the authorities and then market a different product

  18. Scientific Support • The regulatory processes are supported by committees of experts who provide impartial scientific opinions as requested

  19. Product information • A common set of data to be maintained by the person responsible for placing the product on the market • Belongs to industry but must be made available to the authorities on demand

  20. Product information • Qualitative & Quanititative Formula • Material & Finished product specifications • Summary of Method of manufacture complying with GMP • Safety Assessment • Existing data on adverse effects • Supporting data for claimed benefits • Information on the manufacturing manager • Information on the safety assessor

  21. Differences

  22. Differences • Pre-marketing notification process • Scientific Committees • Animal testing limitations

  23. Notification Process • Europe • Single notification of site of manufacture or import and general product types supplied • Information on each product sent to national poison centre • ASEAN • Every product individually notified to enable regulators to assist regulators in-market control measures

  24. Animal Testing in EU • Testing Bans • An immediate testing ban as soon as validated alternatives are available from 01 July 2002 • A testing ban on finished products & prototypes from September 2004 • A testing ban on cosmetic ingredients no later than March 2009 Note ‘testing’ means ‘testing for the purposes of the EU Cosmetic Products Directive’

  25. Animal Testing in EU • Marketing Bans • An immediate marketing ban as soon as validated alternative test methods are available. From 01 July 2002 • For finished products and prototypes the marketing ban is effective from Sept. 2004 • For cosmetic ingredients the marketing ban comes into effect no later than March 2009* * For repeat dose toxicity, reproductive toxicity & toxicokinetics the deadline is no later than March 2013 (With the possibility of extension dependent on technical progress)

  26. Animal testing in ASEAN • All countries accept data generated using animals, some countries require it • The issue of animal testing has become extremely politicised by a small number of activists in Europe and is no longer a purely technical discussion. • The situation will continue to be assessed, including trade implications

  27. Scientific Committees • Europe • The Scientific Committee on Cosmetic Products (SCCP) • ASEAN • The ASEAN Cosmetic Scientific Body (ACSB)

  28. Europe - The SCCP • A group of independent academic scientists and clinicians funded by the European Commission • Provide impartial scientific opinions when requested by the commission

  29. ASEAN - The ACSB • A group of scientists drawn from academia, regulatory bodies and industry • Assess all changes to the EU Directive for applicability to the ASEAN market and make impartial recommendations for changes to ASEAN regulation • Assess ASEAN specific safety and technical issues as requested

  30. Summary • Intentions in EU and ASEAN are identical • Much greater commonality than difference • ASEAN is not Europe • Regulations will continuously evolve • ASEAN spirit will succeed

  31. Thank you all

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