The globalisation of markets:

How to comply

Pr Philippe Masson, PhD

Chairman of the EVIC Inernational Group
Chairman of the CEN/TC 392
1- Practical issues

2- Professional rules

3- Regulatory provisions

4- Need for standardization

5- Conclusions
Practical issues

Free circulation of the products

Biological
effects
Physical Physiological
effects effects

COSMETICS
A SOCIAL
FUNCTION
Psychological Sensorial
impact effects

Recovering effects
for health
Practical issues

Free circulation of the products

 Free circulation of the persons
Practical issues

Free circulation of the products

 Free circulation of the persons
 Different cultural habits and expectations

Decision to use cosmetics is closely linked to lifestyle.

This makes research and

development vital to the
cosmetics’  industry  as  
manufacturers respond to
more and more diversified
consumers’  demands.
Practical issues

Free circulation of the products

 Free circulation of the persons
 Different cultural habits
 Requirement of safety

Consists in assessing the threshold and nature of a potential acceptable risk

Manufacturer Authority Consumer

 Perception is a subjective and qualitative notion

 The risk assessment must first focus on the consumer’s interests
Practical issues

Free circulation of the products

 Free circulation of the persons
 Different cultural habits
 Requirement of safety
 Expectation of efficacy

Consumers’  expectations  
A truthful and understandable information,
A safe cosmetic product
A quickly perceptible effect,
An acceptable cost/quality ratio,
 but first of all the right to dream !
Practical issues

Free circulation of the products

 Free circulation of the persons
 Different cultural habits
 Requirement of safety
 Expectation of efficacy
Make up
A permanent evolution
Hygiene

Personal Care
Mix of products according to
the personality Well being
 Free circulation of the products
 Free circulation of the persons
 Different cultural habits
 Requirement of safety
 Expectation of efficacy

Consumers’  requirements depend on

Their technical and

Their cultural evolution scientific knowledge Their economical means
Practical issues

Cosmetic products are not medicines

• by their function
• by their presentation
but all of them have an activity

ADDITIONAL CHRONOLOGICAL AGING

ENVIRONMENTAL AGING

Restricted to exposed areas cutaneous coating

Ambiental aggressions
Physiological
in addition to the
and morphological changes
chronological changes
Practical issues

Free circulation of the products

 Free circulation of the persons
 Different cultural habits
 Requirement of safety
 Expectation of efficacy
 Requirement of clear information and advertising
Practical issues

According  to  the  consumers’  expectations,  an  appropriate    

labeling should include:

- Manufacturer,  importer  or  distributor’s  name  and  address

- The function of the product
- Conditions of use , if not explicit
- Precautions to be observed in use
- The ingredients and more accurately the allergens
- Potential risks involved
- Nominal content by weight or volume
- Goods identification reference, for example a batch number or
manufacturing code
- Date of minimum durability, or period after opening
Practical issues

Free circulation of the products

 Free circulation of the persons
 Different cultural habits
 Requirement of safety
 Expectation of efficacy
 Requirement of clear information and advertising
 Importance of the reputation
Practical issues

Free circulation of the products

 Free circulation of the persons
 Different cultural habits
 Requirement of safety
 Expectation of efficacy
 Requirement of clear information and advertising
 Importance of the reputation
 Impact of the media
Practical issues
Impact of the media

RISK PERCEPTION ATTENTION OF THE MEDIA

REGULATION POLITICAL PRESSURE

relevance ?
REDUCTION OF THE RISK
economical incidence ?

Source: Nohyneck, 1999

Practical issues

Free circulation of the products

 Free circulation of the persons
 Different cultural habits
 Requirement of safety
 Expectation of efficacy
 Requirement of clear information and advertising
 Importance of the reputation
 Impact of the media
 Local/regional regulatory contraints
1- Practical issues

2- Professional rules

3- Regulatory provisions

4- Need for standardization

5- Conclusions
Professional rules

Basically, the manufacturers ground their activity on the

information and orientations provided by their professional
organizations :
 These may have a national seating. Among others, ANVISA.,
FEBEA,  JCIA,  PCPC,  PCAR,  CTFA…
 They may correspond to international organizations., notably
European,  Asian,  South  American…

The  main  purpose  of  all  these  organizations  “  is  to  promote  the  
cosmetic industry and furthering its scientific, technical, economic
and  legal  objectives”*  and  doing  so,    to  help  their  members  to  
continuing development of safe, innovative and effective products.

* from statutes Cosmetics Europe AISBL-2012

Professional rules

The purpose is achieved mainly by: *

 The joint study of scientific data on substances used in perfumery,
cosmetics, toiletries and hair products, in particular their effects on
human health and safety as well as on the environment.
 The collection and study of laws and regulations applicable to
the industry, then their dissemination to its members and to
appropriate international organizations.
 Fostering transparent and reliable relationships with public
authorities and stakeholders.
 Contributing to the shaping of workable and fair policy frameworks
regulating the cosmetics industry.
 Addressing  members’  needs  through    information  and  decision  
making and focusing on issues and activities relevant for the
cosmetics industry.
* from statutes Cosmetics Europe AISBL-2012
Professional rules

Practically, these organizations, whatever their positioning, resort to

very similar means and proceedings :
 Trying to coordinate and harmonize the activities within the
profession and partners.
 Providing technical and scientific supports.
 Generating professional policies and rules.
 When possible, contributing to simplify, clarify and harmonize
the regulations at national and international level in order to
reduce the barriers for trading.
However, difficulties remain as:
 Number of major members favour own marketing policies
 Number of manufacturers correspond to SMEs, out of control
 Regulations are still different from country to country s
1- Practical issues

2- Professional rules

3- Regulatory provisions

4- Need for standardization

5- Conclusions
Regulatory provisions

Historically cosmetic products have demonstrated to be able to

have effects competing with those of other categories of products:

DRUG

FOOD COSMETICS
Regulatory provisions

Historically cosmetic products have demonstrated to be able to

have effects competing with those of other categories of products:
Benzoyl
Peroxide

Acnea

Selenium Chlorphenesin

It was then necessary to clarify the situation in accordance with the

progress of knowledge and sciences at the time
Regulatory provisions

There is in each country an accurate definition of the cosmetic

product :
It usually refers to a substance or a preparation intended to be
placed in contact with the various external parts of the human
body with a view mainly to cleaning , protecting them,
modifying the aspect, correcting body odours,…

However such a global definition does not correspond to a worldwide

acceptance and a product considered as cosmetic in a given country
may not be seen as such in another.

That mostly concerns the so called « active products » that may

impact on personal and public health
Regulatory provisions

Illustrative examples of product categorisation in different markets

Market
Product type
EU USA Japan Canada
Soap for hands Cosmetic Cosmetic Cosmetic Cosmetic
Lipstick Cosmetic Cosmetic Cosmetic Cosmetic
Over-the-counter Non-prescription
Sunscreen Cosmetic Cosmetic
(OTC drug) drug
Hair dye Cosmetic Cosmetic Quasi-drug Cosmetic
Anti-caries Non-prescription
Cosmetic OTC drug Quasi-drug
toothpaste drug
Non-prescription
Anti-perspirant Cosmetic OTC drug Quasi-drug
drug
Cosmetic or Non-prescription
Anti-acne lotion OTC drug Quasi-drug
Medicinal product drug
Regulatory provisions

For products categorised as cosmetics the regulation is broadly similar

between the major markets:
 Full responsibility of the manufacturer for the safety of products
 In-market surveillance by regulatory authorities
 No requirement for pre-registration
 No restriction on sales channels
 GMP guidelines specially developed for cosmetics

 Regulations focussing on product safety (rather than on efficacy)

... Even if differences remain in the details of the regulations:
 Ingredients allowed or restricted or forbidden
 Nomenclature of the ingredients
 Requirements concerning the labelling
 Information to be kept at disposal or submitted
Regulatory provisions

Cosmetics Cosmeti c
Cosmetics by degrees

1 definition, 4 functions, 1 definition, 6 functions, Cosmetic

2 definitions, 6 functions,
OTC • cleansing
• cleansing • cleansing
•
2d degree
perfuming
• beautifying • perfuming
• promoting • changing the appearance
• changing the appearance
attractiveness • correcting body odours
Drug
• correcting body odours
Drug
• changing the
appearance • protecting Drug
• protecting
• keeping in good conditions
• keeping in good conditions

USA EU BRAZIL
Regulatory provisions

In the E.U, number of countries and Economic Communities

have implemented agreements and even common policy
Regulatory provisions

National Regulations

Cosmetics Directive 76/7608 EEC

6 - Cosmetics Directive 93/35 EEC

7 - Cosmetics Directive EEC

Cosmetics Regulation 1223/2009 EC

Now on new common rules are combating misleading data and reinforcing safety
Regulatory provisions

Since the origin, safety protection and information of the

consumers remain the main objectives of the European cosmetics
legislation

The Regulation establishes rules to be complied with by any

cosmetic product made available on the market, in order to ensure
the functioning of the internal market and a high level of
protection of human health

Information cover now all aspects related to and concern all third
parties involved in the distribution chain of the cosmetic product
Regulatory provisions
Product Information File
Manufacturing method
Description of the Statement on GMP
Cosmetic Product
cosmetic product Safety Report If necessary proof of efficacy
List of animal tests

Part A - Cosmetic Part B - Cosmetic

Product Safety Information Product Safety Assessment

1-Quantitative and qualitative 2-Physical/ chemical characteristics

composition of the product and stability of the cosmetic product 1-Assessment conclusion

4-Impurities,traces,information 2-Labelled warnings and

3- Microbiological quality about the packaging material instructions of use

5-Normal and reasonably 6-Exposure to the

foreseeable use cosmetic product 3-Reasoning

8-Toxicological profile of the 4-Assessor’s  credentials  and  

7-Exposure to the substance substances approval of part B

9-Undesirable effects and 10-Information on the

serious undesirable effects cosmetic product
Regulatory provisions

What about the US situation?

 Everyone agrees with the need to adapt
the old US cosmetics regulation which doesn’t meet anymore the
current expectations

 Following the historical hearing held in Washington by the House

of Representatives in March 2012 concerning the cosmetics’  safety,
three propositions of law have been submitted in order to modify
the federal rules regarding the cosmetic products:

-The Safe Cosmetics Act, HR 2359

targeting the substances well known for their carcinogenic
potential or their toxicitiy on reproduction
Regulatory provisions

-The Cosmetics Safety Enhancement Act, HR 4262

proposing to give to the FDA the power to withdraw cosmetic
products from the market

-The Cosmetics Safety Amendments Act, HR 4395

This main project involves more transparency from the industry
side, aiming to create procedures allowing more involvement of
the FDA ( control of the ingredients, definition of thresholds for
impurities and traces, harmonization of the cosmetic regulation
within the US, examination of the assessments made by the CIR,
implementation of cosmetic GMPs,…)
Regulatory provisions

Summarizing: Two main models of reference

 EU Regulation
Broad definition of cosmetics with safety ensured through controls
over ingredients in the form of lists, specific requirements
concerning safety testing and maintenance of data files

 US Regulation
Narrow definition of cosmetics with few restrictions on the
ingredients and on the type of safety testing
Products that do not meet the definition are regulated as drugs

 Other models are somewhere between

Canada closer to the US model
Japan closer to the EU model
Brazil closer to the EU model
Regulatory provisions

Aside the European Union, number of other countries and

Economic Communities are also implementing agreements
and even common policies:

Mercosul / Cumbre
ASEAN full members
ASEAN observers
ASEAN candidate members
ASEAN Plus Three
East Asia Summit
ASEAN Regional Forum

However in practice and up to now, only few of these communities apply

a common regulation with regard to cosmetic products, most of the
countries keeping their own regulation and generating by the way
difficulties for trading
Regulatory provisions

What about the Chinese situation?

Changing the competent Authority

Food Safety
SFDA Committeee

AQSIQ
CFDA
AIC Food
Food

State Council
Regulatory provisions
CFDA
Commissioner
Zhang Yong

Medical Device
Food Dept. Drug &
Cosmetics Dept. Dept.

Registration Supervision Technology &

Dpt. Dpt. Standards
Wang Lifeng Li Guoqing Dpt.

Drugs Cosmetics
Registration Experts
Registration Huang Min Committee
Regulatory provisions

 Procedure to obtain the Hygiene Permit unchanged

Non special use cosmetics: minimum 8 months for registration
Special use cosmetics: 1 to 2 years for registration

In practice since the Notification made in 2010 only 4 files among the 120
submitted were registered:
- Phenylethylresorcinol
- Dimetthoxytolyl Propylresorcinol
- Polymethacryloyl lysine
- Elaeaginus mollis diel oil
Regulatory provisions

 Procedure to register new ingredients unclear

2 batches among the 6 announced have been published
( only 2085 ingredients are listed)

Special use cosmetics: 1 to 2 years for registration

The proceedings are completely unclear:

- No visibility concerning the file to be submitted
- Requirements concerning chemical, analytical, toxicological data
are very heavy and sometimes irrelevant
- No visibility concerning the file for natural ingredients
- No visibility concerning the possible questioning of the experts
Regulatory provisions

UV filters, colorants, hairdyes,

authorised preservatives

New ingredient
Ingredient in
a Chinese
positive list
Ingredient in
the unofficial
SFDA
inventory (= Ingredient in
CTFA Batch CFDA
2002/2004 ) concentration  ≤  
to the one
mentioned
New ingredient
Regulatory provisions

 A first signal of evolution?

China plans to remove its mandatory animal test

requirements for domestically manufactured cosmetic
products.

For the first time ever, Chinese companies producing "non-special

use cosmetics" such as shampoo or perfume will have the option
to substantiate product safety using existing safety data for raw
ingredients, or European Union-validated non-animal tests
instead of having to submit product samples to the government
for testing on rabbits, mice and rats.
1- Practical issues

2- Professional rules

3- Regulatory provisions

4- Need for standardization

5- Conclusions
Need for standardization

 Due to the differences existing around the world concerning the

technical knowledge and innovation levels in the cosmetics area,
 Due to the differences still remaining between legislations in the
main countries where the majority of cosmetic products are
produced and/or consumed,
 Due also to the different level of consumers’  expectations
 Then considering the practical difficulties to find in the short
time any possibility in implementing a global legislation acceptable
internationally,
 Considering as well the practical incapacity for the own
stakeholders to develop in common professional guidances
acceptable worldwide by the concerned authorities,
Need for standardization

It appeared necessary to have a pragmatic approach, allowing to

develop in common, step by step, reference documents covering
specific technical aspects and proceedings, at least allowing to
avoid useless repetitions of techniques and procedures.

Reference document : - reached by consensus

- applied voluntarily (usually)
- providing solutions to specific items
- covering all economical areas

Professional specifications application is voluntary

Standard application is voluntary

(except in specific cases)
Regulatory document application is mandatory
Need for standardization

Definitions of  'Standardization‘
Standardization may have different meanings:
1 - making something conforming with a given standard
2 - making something conforming with an unique model

- Standardization can help to maximize compatibility, interoperability,

safety, repeatability or quality. It can also facilitate commoditization of
formerly custom processes. Wikipedia

- A framework of agreements to which all relevant parties in an industry

or organization must adhere to ensure that all processes associated with
the creation of a good or performance of a service are performed within
set guidelines. This is done to ensure the end product has consistent
quality, and that any conclusions made are comparable with all other
equivalent items in the same class. Investopedia
Need for standardization

Definitions  of  'Standardization‘

- Activity of establishing, with regard to actual or potential problems,
provisions for common and repeated use, aimed at the achievement
of the optimum degree of order in a given context.
NOTE 1 In particular, the activity consists in the processes of
formulating, issuing and implementing standards.
NOTE 2 Important benefits of standardization are improvement of
the suitability of products, processes and services for their intended
purposes, prevention of barriers to trade and facilitation of
technological cooperation.

European Standard EN 45020 200

Need for standardization

Definitions  of  'Standardization‘

- Standardization corresponds to an activity of general interest aiming to
provide frames of reference reached by consensus by all relevant parties
concerning rules, characteristics, recommendations, or good practices,
related to products, services, methods, process or organizations.
It aims to encourage the economical development and innovation while
taking into consideration long lasting development
French Decree n° 2009-697 du 16 juin 2009

- Consensus
Frame of reference
refers to is a document
a general elaborated,
agreement, applied voluntarily,
characterized by the absence
providing
of in opposition
sustained all economical areas practical
to substantial issuessolutions to repetitive
by any important parttechnical,
of the
commercial,
concerned societaland
interests questions
by a process that involves seeking to take into
account the views of all parties concerned and to reconcile any conflicting
arguments NOTE : Consensus does not imply unanimity.
European Standard EN 45020 2007
Need for standardization

The expert : function, competences and role

Functions Competences Role

Expert Technical  To anticipate

 To prepare
Delegate Economical  To participate
Poject leader  Good command  To explain
of presentation  To try to find
Organizer and writing alliances
Linguistic  To liase
President
Animation  To negotiate
Need for standardization

International, European and National Standards

International standards : transpositions are voluntary

International
CEN
ISO level

BSI National
level

European
CEN level

European standards : transpositions are mandatory

Need for standardization

Organisation, structure of the standardization program

Founding : 1961
Head office : Brussels
CEN members are members of the Technical Committee

Experts
(drafting of standards)
Work Program
and Strategy WG 1

WG n

Adoption of the European standards by the Member States based on qualified

majority

Three official languages : English, French, German

Need for standardization

Technical Committee CEN TC 392

Scope : to cover all methodological aspects related to the cosmetic area

Organization :

Chairmanship : France WG1 –Analytical methods

WG2 – Microbiological methods

Created in 2009

Secretaryship : France WG4- Efficacy and sun protection products

Finalities :
 to refer to recognized references when exporting the products
 to have methods at disposal for the control and survey of the market
Need for standardization

Technical Committee ISO TC 217

Scope : to cover all methodological aspects related to the cosmetic area

Organization : WG1 – Microbiological methods

WG2 – Packaging and labelling

Chairmanship : England
GT3 – Analytical methods

Created in 1998 WG4- Terminology

WG6 – Good Manufacturing Practices

Secretaryship : Iran
WG7- Sun protection products

WG8 – Nanotechnologies
Finalities :
 to refer to recognized references when exporting the products
 to have methods at disposal for the control and survey of the market
Need for standardization

Steps for implementing a standard

New Work Item Proposal (NWIP)
Status, target dates

Setting up
Inscription to the
Working Program

Elaboration of the project WD

Follow up
3 years

CD Inquiry (3 months)

DIS Inquiry (5 months)

FDIS Vote (2 months)

Adoption
Publication
Need for standardization

Example: Method for analysis of the allergens

 Title
NWIP 0347007 : Method for analysis of the allergens – Quantification of
perfuming substances suspected of being allergenic in the consumer products
Step 1: Analysis by CG of sample ready to be injected
 Stakes
 To support public policies
 To protect the consumers
 To meet the main requirements of the directive concerning the
harmonization of the legislations of the Member States relating t
cosmetic products
Regulation 1223/2009 EC – Annex III – List of the substances that
the cosmetic products cannot contain apart from the restrictions
and conditions forecasted
Need for standardization

Example: Method for analysis of the allergens

 Objectives
To describe a method for identification and assay of 24 volatile allergens
suspected of being present in the cosmetic products.
The analysis is carried through CG-MS coupling on samples previously
prepared.
The standard does not refer to the preparation of the cosmetic samples
but only to the method to be used concerning the product ready to be
injected.
 Purpose
 Implementation of a common set of references
 Enhancement of the contractual relations between the different
intervening parties
Need for standardization

Pitfalls met from a normative point of view

 Difficulty in mobilizing experts to participate in the preparation of

horizontal standards

 Lack of balance in the involvement of the different sectors concerned

 Difficulty in remaining within the framework of the mandate given to
the working group

 Difficulty in respecting the time allowed when additional works prove

to be necessary

The standardization must reach a consensus

from preexisting data or methods
Need for standardization

Satisfactions resulting from the standardization

 Approach accessible to all the persons concerned

 Meeting with qualified experts of different origins and training
favouring the solutions by consensus

 Preparation of documents contributing to solve technical, commercial,

societal and regulatory questions

 Economical impact as voluntary means favouring a better mutual

understanding, world harmonization, and market globalization

The last meeting of the TC 217 was in Auckland

.... therefore also a way to discover the world!
1- Practical issues

2- Professional rules

3- Regulatory provisions

4- Need for standardization

5- Conclusions
Conclusions

What to say?

1- With the space and time between locations becoming

smaller as communications and technology increase
worldwide, it continues to get easier to sell products to the far
corners of the world.
But when a product is made in one country and sold in or
bought online from a variety of locations, at which point do
the various global regulations become relevant for the
product?
Conclusions

What to say?

2- Will there rules currently in place regarding standards to

include regulatory, compliance and commercial /trading
standards within the EU for cosmetic and personal care
products?

3- Building awareness of similar standards that may exist

beyond the Eurozone i.e. in other trading regions of the
world - will it be true harmony across all boarders or will
there still remain national / regional distinctions?
Conclusions

What to say?
4- What has been the practical contribution of the
standardization in the cosmetic universe over the last 50
years and what the future could look like?
Conclusions

Benefits of the standardization

Rationalize the production
Clarify Transfer new
transactions technologies

Develop
Help for
markets Standardization
strategic decisions

Select
Protect consumers
products

Sustain public policies

Conclusions

General overview of the standardization works carried out

in the cosmetic field

Microbiological methods

Good Manufacturing Practices

Analytical methods
19 standards
published since Terminology
2009
Photoprotection efficacy
Packaging, labelling and Marking

17 new subjects enrolled in the

working programme
Thank you for your attention