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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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Regulation EC No1223/2009 (CPR)

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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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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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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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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Use of claims referring to animal testing

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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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• Background:







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……..

……..

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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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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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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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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.”


• 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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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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4. Honesty

“Claims should not attribute to the product concerned

specific (i.e. unique) characteristics if similar products

possess the same characteristics“


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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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“


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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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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• Background:







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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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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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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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“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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“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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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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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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Conclusions:

Thank you for your attention

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