Comparison between EU and

ASEAN Directives

Simon YoungDirector of External AffairsUnilever Asia & Africa

Overview

Setting the scene

Similarities

Differences

Summary

Setting the Scene

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

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

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

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

Similarities

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

Aims

To ensure safety of cosmetic products

To enable free trade of cosmetic products with no pre-marketing registration approval

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

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.

Ingredients

Annex II - The banned listAnnex III - The restricted listAnnex IV - Colourants positive listAnnex VI - Preservatives positive listAnnex VII - UV Filters positive list

Product Safety

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

Product Safety

Regulation should be underpinned by sound scientific opinion

International approach to safety assessment has been adopted

Scientific Committee trained by EU experts

Pre-marketing Approval

Industry is responsible for assessing compliance with regulation prior to launch

No product pre-marketing approval by regulators is required

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

Scientific Support

The regulatory processes are supported by committees of experts who provide impartial scientific opinions as requested

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

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

Differences

Differences

Pre-marketing notification processScientific Committees Animal testing limitations

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

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’

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)

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

Scientific Committees

EuropeThe Scientific Committee on Cosmetic

Products (SCCP)

ASEANThe ASEAN Cosmetic Scientific Body (ACSB)

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

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

Summary

Intentions in EU and ASEAN are identicalMuch greater commonality than differenceASEAN is not EuropeRegulations will continuously evolveASEAN spirit will succeed

Thank you all