Issues Affecting Cosmetic Ingredients
Guidelines on Claims Current EU Commission activities on claims
PCPC Science Symposium
Newark, NJ
October 3, 2012
Silvia Boracchi
AGER, Italy
Overview of presentation
• Background:
• the new Cosmetic Products Regulation (CPR)
and the importance of claims
• the EU rules in the cosmetic sector
• The EU Commission Guidelines on Claims: does the
product’s claims issue affect ingredients suppliers?
• The “free-of” claims
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General, applicable to all sectors
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The applicable EU rules
• Art 3 (a) of CPR on safety of cosmetic products
• e.g. cosmetics which look like foodstuffs
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The applicable EU rules
General, applicable to all sectors
DIRECTIVE 2005/29/EC OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL
of 11 May 2005
concerning unfair business-to-consumer commercial practices
• unfair = is contrary to professional diligence’s requirements
and distorts the economic behaviour of the average
consumer whom it reaches
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The applicable EU rules
General, applicable to all sectors
DIRECTIVE 2006/114/EC OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL
of 12 December 2006
concerning misleading and comparative advertising
• aims at protecting traders against unfair practices deceiving
consumers and injuring competitors
Specific for the cosmetic sector
• Guidance documents on the delimitation between cosmetics and other product categories (EU Com)
• EU Com Recommendation on the use of claims referring to the absence of tests on animal (2006)
• EU Com Recommendation on the efficacy of sunscreen products and related claims (2006)
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The applicable EU rules
http://ec.europa.eu/consumers/sectors/cosmetics/documents/guidelines/index_en.htm
Guidance documents on borderline products:
• on the Demarcation between the Cosmetic Products Directive 76/768/EEC and the Medicinal Products Directive 2001/83/EC (2004)
• Borderline between Directive 98/8/EC concerning the placing on the market of biocidal products and Directive 76/768/EEC concerning cosmetic products (2004) – Manual of decisions (July 2005)
• Manual on the scope of application of the Cosmetic Products Directive 76/768/EEC (June 2011)
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The applicable EU rules
Use of claims referring to animal testing
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The applicable EU rules
http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-testing/
Use of claims referring to animal testing
• It is possible to claim on a cosmetic product that
no animal testing was carried out in relation to its
development
• Conditions for use of the claim:
the manufacturer and his suppliers have not carried
out or commissioned any animal tests on the finished
product, or its prototype or any of the ingredients
contained in it, or used any ingredients that have been
tested on animals by others for the purpose of
developing new cosmetic products
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The applicable EU rules
Overview of presentation
• Background:
• the new Cosmetic Products Regulation (CPR)
and the importance of claims
• the EU rules in the cosmetic sector
• The EU Commission Guidelines on Claims: does the
product’s claims issue affect ingredients suppliers?
• The “free-of” claims
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Regulation EC No1223/2009 (CPR)
The Commission action plan:
• Establish guidelines for general criteria (all claims)
• Establish additional criteria (specific claims)
• Implementation of guidelines……………….. 2012
• Compliance monitoring …………….. 2012 - 2015
• Report for the EP ………………………….... 2016
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• Purpose: to implement the provisions on the CPR and establish a set of common criteria for claims on cosmetics • Sub-working group:
EU Commission (DG Health and Consumers) Member States (Competent Authorities) Industry (Cosmetics Europe, EFfCI, IFRA, …) Consumers (BEUC) • Meetings May 2010 - May 2012 final draft Guidelines approved by the EU Working Party in November 2011 – currently under translation
The EU Commission Guidelines on Claims
LIST OF COMMON CRITERIA FOR CLAIMS
WHICH MAY BE USED WITH RESPECT TO COSMETIC PRODUCTS
ACCORDING TO ARTICLE 20 OF REGULATION (EC) N° 1223/2009
(UPDATED VERSION – 24/02/12)
Identification of general common criteria applicable to
all type of claims, with examples of unacceptable claims
ANNEX I: “Best practices for claim substantiation evidence”
Probably to be implemented as Commission Decision
(legally binding act)
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The EU Commission Guidelines on Claims
How does the product’s claims issue affect
ingredients suppliers?
• In general the majority of claims refer to finished
cosmetic products, but the features of a products can be
referenced directly to its ingredients
• Finished products’ claims can convey denigrating and
misleading messages on certain ingredients, thus leading
to prohibited marketing practices
EFfCI took an active role in the preparation of the
EU Commission Guidelines on claims
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Role of ingredients Suppliers
General common criteria for all type of claims:
1. Legal compliance
2. Truthfulness
3. Evidence support
4. Honesty
5. Fairness
6. Allow informed decisions
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The EU Commission Guidelines on Claims
1. Legal compliance
“Claiming mere compliance with minimum legal requirements
should not be allowed” CPR, Dir 2005/29 (unfair commercial practices),
Dir 2006/114 (misleading and comparative advertising)
Unacceptable claims:
• EXAMPLE: the claim ‘skin care product does not contain
hydroquinone’ is not allowed, as hydroquinone is banned by
EU cosmetics legislation for this use.
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The EU Commission Guidelines on Claims
2. Truthfulness
“….must not be based on false or irrelevant information.
If a product claims that it contains a specific ingredient, the
ingredient must be deliberately present.”
Unacceptable claims:
• EXAMPLE: product claiming ‘contains honey’ must
actually contain honey, and not only honey flavour
• EXAMPLE: the claim ‘contains moisturising aloe vera’
should not be made if the product itself has no moisturising
effect
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The EU Commission Guidelines on Claims
3. Evidence support
“The responsible person determines the appropriate
supporting evidence (must be justified where necessary in
the product information file)”
“A claim extrapolating ingredient properties to the finished
product must be supported by adequate and appropriate
evidence, e.g. by demonstrating the presence of the
ingredient at an effective concentration, etc.”
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The EU Commission Guidelines on Claims
4. Honesty
“Claims should not attribute to the product concerned
specific (i.e. unique) characteristics if similar products
possess the same characteristics“
Unacceptable claims:
EXAMPLE: fine fragrances usually contain such a high
amount of alcohol that the additional use of preservatives is
not necessary. In this case, it would be dishonest to
highlight in advertising the fact that a certain fine fragrance
does not contain any preservatives.
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The EU Commission Guidelines on Claims
5. Fairness
“Claims for cosmetic products shall be objective and shall
not denigrate the competition, nor shall they denigrate
ingredients legally and safely used in cosmetic
products“
Unacceptable claims:
EXAMPLE: ‘well tolerated as it does not contain mineral
oils’ is an unfair statement towards other products which
are equally well tolerated
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The EU Commission Guidelines on Claims
6. Allow informed decisions
“Claims should be clear and understandable to the average
consumer and include the information needed by an
average consumer to take an informed decision”
Annex I
Best practice for claim substantiation evidence
defines “best practices” in relation to the type of support
used (experimental studies, consumer perception test, use
of published information, etc)
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The EU Commission Guidelines on Claims
Overview of presentation
• Background:
• the new Cosmetic Products Regulation (CPR)
and the importance of claims
• the EU rules in the cosmetic sector
• The EU Commission Guidelines on Claims: does the
product’s claims issue affect ingredients suppliers?
• The “free-of” claims
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• October 2011: discussion on so called “free-of” claims
starts
• “Free- of” claims: claims relating to the absence of
particular ingredients (free of, without, does not contain..)
• Such claims were recognized in the sub WG as “specific”
claims, for whom compliance with the general criteria is not
sufficient to ensure fair communication
Need to define additional criteria, to be included in a
separate Annex
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The EU Commission Guidelines on Claims
EFfCI focus:
claims referring to the absence of certain substances in
cosmetic products could be used to suggest that such
products are safer than products containing the ingredients
in question
• unfair denigration of “legal” ingredients which can be
used safely in cosmetics – and are sometimes
explicitly approved
• inconsistency with adopted common criteria and legal
provisions (CPR, Dir 2005/29 Dir 2006/114)
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The EU Commission Guidelines on Claims
Parabens are safe when used at the conditions indicated by
the Safety Committee on Consumer Safety (SCCS/1446/11)
“Parabens free” is a misleading claims because
“it risks conferring a false advantage on the product to
which it is applied, and it is arguably intended to mislead
consumers guiding them to believe the product would be
safer than other products, to the detriment of consumers
and competitors”
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The EU Commission Guidelines on Claims
“parabens free ”: a good example of misleading claim
The claim is often used in a denigrating context,
speculating on the negative public perception on
nanomaterials in cosmetic formulations
“Nano” does not mean unsafe!
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The EU Commission Guidelines on Claims
“nano free ”: again, a misleading claim
free of silicon
free of propylen glycol
free of formaldehyde
free of sulfates
free of ethoxilates
…………… Claims based on a presumed negative perception by the
consumers on the safety of single substances and or
chemical families!
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The EU Commission Guidelines on Claims
Other example of misleading claims:
Free of claims should be permitted when they allow an
informed choice to a consumer sub-population
Some consumers may wish e.g. to avoid certain
ingredients due to life-style choices or religious reasons
alcohol free
free of animal derived ingredients
no perfume added (when no perfuming substance is present)
Kosher
Halal
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The EU Commission Guidelines on Claims
Acceptable claims under discussion
EFfCI would like to see clear indications from the EU COM
criteria to be adopted for a fair use of free of claims
Consumers must not be guided into believing that certain
cosmetic products are safer than others… the CPR does not
prescribe different levels of safety!
From “DOES CONTAIN” to “DOES NOT CONTAIN”?
…a negative feed back for the whole sector
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The EU Commission Guidelines on Claims
Conclusions: