comparison between eu and asean directives
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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 - PowerPoint PPT PresentationTRANSCRIPT
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Comparison between EU and
ASEAN Directives
Simon YoungDirector of External AffairsUnilever Asia & Africa
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Overview
Setting the scene
Similarities
Differences
Summary
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Setting the Scene
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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
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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
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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
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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
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Similarities
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Similarities
Common aimsCommon definition of scopeCommon regulation of ingredientsCommon approach to product safetyNo pre-marketing approval processFocus on in-market controlScientific support processesData to be maintained
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Aims
To ensure safety of cosmetic products
To enable free trade of cosmetic products with no pre-marketing registration approval
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Scope
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 cleaning them, perfuming them, changing their appearance, and/or correcting body odours and/or protecting or keeping them in good condition
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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.
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Ingredients
Annex II - The banned listAnnex III - The restricted listAnnex IV - Colourants positive listAnnex VI - Preservatives positive listAnnex VII - UV Filters positive list
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Product Safety
A cosmetic product must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use
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Product Safety
Regulation should be underpinned by sound scientific opinion
International approach to safety assessment has been adopted
Scientific Committee trained by EU experts
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Pre-marketing Approval
Industry is responsible for assessing compliance with regulation prior to launch
No product pre-marketing approval by regulators is required
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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
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Scientific Support
The regulatory processes are supported by committees of experts who provide impartial scientific opinions as requested
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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
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Product information
Qualitative & Quanititative FormulaMaterial & Finished product specificationsSummary of Method of manufacture complying
with GMPSafety AssessmentExisting data on adverse effectsSupporting data for claimed benefits Information on the manufacturing manager Information on the safety assessor
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Differences
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Differences
Pre-marketing notification processScientific Committees Animal testing limitations
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Notification ProcessEurope
Single notification of site of manufacture or import and general product types supplied
Information on each product sent to national poison centreASEAN
Every product individually notified to enable regulators to assist regulators in-market control measures
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Animal Testing in EU
Testing BansAn 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’
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Animal Testing in EUMarketing 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)
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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
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Scientific Committees
EuropeThe Scientific Committee on Cosmetic
Products (SCCP)
ASEANThe ASEAN Cosmetic Scientific Body (ACSB)
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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
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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
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Summary
Intentions in EU and ASEAN are identicalMuch greater commonality than differenceASEAN is not EuropeRegulations will continuously evolveASEAN spirit will succeed
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Thank you all