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ENJEUX SANITAIRES ET RÉGLEMENTAIRES : FAUX

PROBLÈMES ET VRAIES QUESTIONS

Françoise AUDEBERT

Aurore BOUDET MOUFAREK 9 avril 2013

Enjeux sanitaires et réglementaires : faux problèmes et vraies questions - 09/04/2013

PERFUME & REGULATORY ISSUES IN EUROPE

1. Definition Fragrance ingredient Fragrance compound Perfume 2. Regulatory requirements Fragrance compound Perfume

3. Fragrance allergens – SCCS opinion

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Definition – fragrance ingredient

By definition a fragrance ingredient is a substance. Regulation (EC) N°1223/2009 - Article 2 “‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition”

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Definition – fragrance compound

By definition a fragrance compound is a mixture – a mix of fragrance ingredients – that will enter composition of a perfume. Regulation (EC) N°1223/2009 - Article 2 “‘mixture’ means a mixture or solution composed of two or more substances.” For example: Fine fragrance perfume for women contains around 20% of fragrance compound Shower gel contains around 1% of fragrance compound Body cream contains around 0.5% of fragrance compound

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Definition – perfume

By definition a perfume as a finished product is a cosmetic product. Regulation (EC) N°1223/2009 - Article 2 “‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”

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Regulatory requirements fragrance compound

By definition a fragrance compound is a mixture – a mix of fragrance ingredients – that will enter composition of a perfume. As part of a perfume (cosmetic product) a fragrance compound should conform: àREACH/CLP àRegulation (EC) N°1223/2009 (cosmetic regulation) àIFRA Code of Practice àClient’s brief and requirements

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àREACH /CLP As substances and mixtures perfume ingredients must comply to: • Regulation (EC) n°1907/2006: REACH • Regulation (EC) n°1272/2008: CLP Ingredients classified as CMR by Regulation CLP are now automatically forbidden They shall only be used with a positive opinion of the SCCS IFRA has updated its transparency list, which lists ingredients that may be contained in fragrance compounds.


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àRegulation (EC) N°1223/2009 (cosmetic regulation) Annexes of cosmetic regulation

Annex III List of substances which cosmetic products must not contain except subject to the restrictions laid down Example :


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àRegulation (EC) N°1223/2009 (cosmetic regulation) Annexes of cosmetic regulation

Annex V List of preservatives allowed in cosmetic products Example: à Perfume ingredients in Cosmetic Regulation annexes can be: • limited in concentration • labelled on finished product (26 allergens only) Restrictions depend on finished product


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àIFRA Code of Practice (1) The IFRA Code of Practice applies to the manufacture and handling of all fragrance materials, for all types of applications and contains the full set of IFRA Standards. The IFRA Code of Practice is no Regulation (soft law) A binding by the IFRA Code of Practice is only a prerequisite for all fragrance supplier companies that are members of IFRA (either directly or through national associations).


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àIFRA Code of Practice (2) Amendments to the Code, if required, were issued annually until 2011, and are now issued every 2 years starting 2013, based on new scientific developments. These contain either new usage restrictions or revisions of existing usage restrictions. 47th Amendment will be issued this spring (2013)


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By definition a perfume as a finished product is a cosmetic product. As a cosmetic product a perfume should conform: àRegulation (EC) N°1223/2009 (cosmetic regulation) such as:

> Product Information File – new format > Notification – new > Product claims (free of) – new guidelines > Cosmetovigilance – modified > Labeling requirements

Regulatory requirements cosmetic product

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> Product Information File – new format (1) Regulation (EC) N°1223/2009 - Article 11 and Annex I Fragrance suppliers deliver a specific file for each fragrance compound. This file will provide any information needed by cosmetic product manufacturer in order to establish its Product Information File. Nevertheless the exact fragrance formula won’t be disclosed for confidentiality reason (intellectual property doesn’t exist for fragrance formula)


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> Product Information File – new format (2) Annex I Cosmetic Product Safety Report

A – Cosmetic product safety information 1.  Quantitative and qualitative composition of the cosmetic product 2.  Physical/chemical characteristics and stability of the cosmetic product 3.  Microbiological quality 4.  Impurities, traces, information about the packaging material 5.  Normal and reasonably forseeable use 6.  Exposure to the cosmetic product 7.  Exposure to the substances 8.  Toxicogical profile of the substances 9.  Undesirable effects and serious undesirable effects 10.  Information on the cosmetic product B - Cosmetic product safety assessment 1.  Assessment conclusion 2.  Labelled warnings and instructions of use 3.  Reasoning


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> Product Information File – new format (3) Essential Documents

The fragrance compound must still be considered in the safety assessment of the finished product: • Safety data sheet in compliance with the current EU regulation (> 01.12.2010) • Reasoned evaluation of the safety of the fragrance compound for its intended use (see guidelines IFRA/COLIPA below) • Certificate of compliance with IFRA standards currently in place (46th amendment) • List of substances regulated in the annexes of the Cosmetic regulation: presence (INCI names)and concentration(INCI names)

• Statement of compliance of the ingredients used in the compound with relevant EU chemical control legislation

Guidelines on exchange of information between fragrance suppliers and cosmetic manufacturers Final 06-2011.pdf


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> Notification / CPNP – new Regulation (EC) N°1223/2009 - Article 13 Prior to placing the cosmetic product on the market the responsible person shall notify it on the Cosmetic Product Notification Portal (CPNP). Different types of cosmetic product composition declarations: • Predefined frame formulation • Exact concentration • Concentration ranges Fragrance composition will never be disclosed on CPNP.


The easiest for perfume

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> Product claims – new guidelines (1) Regulation (EC) N°1223/2009 - Article 20 The Commission shall adopt a list of common criteria for claims which may be used in respect of cosmetic products, Regulation on common criteria should be published next june and apply on July 11th, 2103. Regulation (EU) n°xx/xxx laying down common criteria for the justification of claims used in relation to cosmetic products « Free of » claims: shall become Annex II to the Regulation on the common criteria shall be published by the end of 2013 (with an update of above Regulation)


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> Product claims – new guidelines (2) « free of fragrance » Discussion on going - 2 positions • The presence of a fragrance compound in a cosmetic product must be declared in the ingredients list by the INCI name 'parfum' or 'perfume'. Consequently, the claim 'fragrance-free' may not be made for any cosmetic that is required to declare 'parfum' or 'perfume' on the label. The claim 'fragrance-free' should not be made for any cosmetic that is required to label one or more of the 26 substances required to be labelled above certain threshold levels (allergens). • In order to justify the use of the claim 'fragrance-free' in respect of a cosmetic product that is clearly not without smell, the manufacturer must be able to demonstrate that all the ingredient in the product from any source have a main function other than fragrance. For ingredients that are typically used in fragrances, like essential oils, the perfuming function should always be considered as one of the main functions.


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> Product claims – new guidelines (3) « hypoallergenic » • The Federation believes that the industry should refrain from any denigrating message regarding the 26 allergens regardless of the type of product. For example, are not allowed expressions such as: - Number of "allergens" reduced. - Better tolerated because contains less "allergens". - Product formulated without "allergen". -  "allergen" free perfume, hypoallergenic perfume.

• The word cannot be used for products whose main function is to perfume, would they contain alcohol or not. For example, are not allowed phrases like: - "Hypoallergenic perfume" - "Fragrance formulated to reduce / minimize the risk of allergy".


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> Product claims – new guidelines (4) « hypoallergenic » • The word can be used for skincare products, hygiene or makeup only if: - The list of ingredients does not contain any of the 26 allergens listed in Annex III of the Cosmetic Regulation

And - The product folder contains the necessary scientific evidence.

BUT We still don’t know European Commission and Member States will choose a definition of hypoallergenic.


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> Cosmetovigilance (1) Article 23 Communication of serious undesirable effects 1. In the event of serious undesirable effects, the

responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred:

(a) all serious undesirable effects which are known to him or which may reasonably be expected to be known to him;

(b) the name of the cosmetic product concerned, enabling its specific identification;

(c) the corrective measures taken by him, if any.


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> Cosmetovigilance (2) Article 23 Communication of serious undesirable effects 2. Where the responsible person/distributor reports serious

undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member states Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer


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> Cosmetovigilance (3) Definition of serious undesirable effects (SUE) Serious undesirable effects are defined as “undesirable effects

which result in: •  temporary or permanent functional incapacity, •  disability, •  hospitalisation, •  congenital anomalies or •  an immediate vital risk or death”. To be notified •  All SUE cases, except those classified as ‘excluded’ in

causality assessment •  Causality assessment is an analysis of causal association,

on a case-by-case basis, in an attempt to determine the probability that a serious undesirable event is attributable to a well identified product used by an end user.


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> Cosmetovigilance (4)

Article 23 Consequences •  Most frequent undesirable effect: allergy to perfumes

and hair dyes

•  Serious undesirable effect will be declared: seriousness and causality to be assessed "before" any declaration.


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> Cosmetovigilance (5) Article 23 Consequences •  Might require specialist medical assessment — this is

recommended in complex cases, the impact on the user’s health is deemed serious.

•  Will need additional examinations reliable and specific to the observed effect and performed by specialist physicians

•  Possible questions from the responsible person and the

competent authorities to the suppliers


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"FAUX PROBLÈMES ET VRAIES QUESTIONS" SCCS opinion on fragrance allergens

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SCCS opinion on fragrance allergens (1)

Regulatory measures suggested by the SCCS opinion •  Ban of the fragrance ingredient Hydroxyisohexyl 3-

cyclohexene carboxaldehyde (HICC)

•  Ban of chloroatranol and atranol, which are constituents of oakmoss and treemoss.

•  Restriction of use concentrations of eleven fragrance materials to 100 ppm. (eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, (DL)-Limonene, linalool, coumarine, cinnamal, cinnamyl alcohol, citral)

•  Significant increase of scope for consumer information

(allergen declaration)

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Critical analysis of this opinion •  Classification of “established allergens” based on results of patch tests with no further analysis, without taking into account the level of exposure •  Comments on evidence and classification quality requirements for a study to be included in evaluation are low

•  Assessment based on hazard not risk

•  Regulatory measures focused on sensitized consumers

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IFRA impact analysis of this opinion: economic 1. Ban of HICC and restrictions to 100ppm (65% of the European market represented): •  reformulation of fragrance formulae for perfumes (about 90%) cosmetics and toiletries (78% - 88%) would represent a total cost of approximately 364 M€ for the entire European fragrance industry.

2. Extended labelling Percentage of formulae concerned •  Leave on products: 99,5% •  Rinse off products: 96,2% For the best selling formulae the number of allergens to label •  Leave on products: from 7 to 21 •  Rinse off products: from 4 to 9 29



FEBEA impact analysis of this opinion IN FRANCE •  Ban of HICC

•  Perfumes and: up to 75% fall with the turnover •  Other cosmetic products: 6650 formulae impacted

•  Restriction to 100 ppm •  Perfumes up to 100% fall with turn over •  Other cosmetic product: about 26000 formulae impacted

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Impact analysis of this opinion: economic… but not only In terms of creativity, some of the allergens concerned are: •  critical (geraniol, citral, coumarin, linalool, limonen) •  important (hydroxycitronellal, eugenol, isoeugenol, cinnamal) Reduction of natural ingredients (essential oil of orange, bergamots, lemon, lavender…) •  391 of the 536 natural ingredients used count at least one of the restricted ingredients at a level > 0.01% •  Would strongly affect the upstream industry, the agriculture sector (southern Europe)

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Impact analysis of this opinion: creativity, innovation, upstream industry •  Disappearance of the European fragrance heritage linked

to known fine fragrance brands •  Significant modification of the olfactive signature •  Uniformisation of fragrance notes on the EU market

(disappearance of key olfactive families) •  Loss of quality and creative potential (natural ingredients

are the only option to provide the high quality compositions for creating fine fragrances)

Would generate massive costs and durably affect the competitiveness and innovation ability of the European fragrance industry.

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Common industry positions for a regulatory follow up HICC: Allow a smooth phase-out of HICC by advocating a restriction to 100 ppm. However, this position has to be reconsidered, should the discussions around HICC risk to jeopardize the outcome of the remaining 11 substances, by far the more important and strategic ones. Atranol/chloroatranol: Reduce content to confirmed safe levels, which are still of benefit for the use of the material.

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Common industry positions for a regulatory follow up Restriction of 11 allergens to 100ppm:

Use QRA approach and apply restrictions based on induction risk assessment. Implement eventual refinements (such as aggregate exposures) according to recommendations from IFRA work plan.

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Theoretical number of allergens (82 allergens i.e. Table 13.1)

Application of a threshold for declaration (today 10/100ppm)

Number of fragrance allergens to be

declared per product

Scope of consumer information

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Consumer information: Industry objectives •  Equip DG Sanco with the elements for a constructive

regulatory follow-up on consumer information, which is at the same time workable for the industry

•  keeping the existing declaration threshold in the finished product (10/100ppm)

•  addressing the full list of 82 ingredients, although via a step by step approach. The steps will be defined based on a substance by substance analysis with regard to analytical feasibility, safety parameters like allergy potency and exposure considerations

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Thank you for your attention

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