Transcript Cosmetics Europe The Personal Care Association

Ingredients under the
spotlight
Karolina Brzuska
Issue Manager, Technical Regulatory Affairs
Cosmetics Europe
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Overview:
• Cosmetics Europe The Personal Care Association
• EU and international trends triggering
review of ingredients’ safety
• Mistakes in Ingredients Annexes
• Why preservatives need to be preserved?
• Challenges with the EU approach on CMRs
• Key ingredients under the spotlight
• Recent regulatory proposals
• Overview of the recent SCCS opinions and pending
requests
• Reflection on the coming year(s)
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Congrès Parfums & Cosmétiques – Chartres
Cosmetics Europe
Cosmetics Europe is the European trade
association representing the interests of the
cosmetics, toiletry and perfumery industry.
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Congrès Parfums & Cosmétiques – Chartres
Key Figures 2013
 Europe is the flagship producer and mass consumer market of cosmetics
and personal care products in the world. The European cosmetics industry
represents one-third of the global cosmetics market, which is more than
the US and Japanese markets combined (Source: Euromonitor, 2013)
 More than 4,000 companies operate in the EU cosmetics industry, two
thirds of which are SMEs
 The European Cosmetics industry employs approximately 25,000 scientists
(2013 figures)
 Direct and indirect employment in the European cosmetics industry is
approx. 1.5 million people (Source: Euromonitor, 2013 figures)
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Corporate Members
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Correspondent Members
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National Associations
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Austria -FCIO
Belgium -DETIC
Bulgaria - BNAEOPC
Czech Republic - CSZV
Denmark -SPT
Estonia - FECI
Finland - TY
France - FEBEA
Germany - IKW
Greece - PSVAK
Hungary - KOZMOS
Ireland - ICDA
Italy – COSMETICA ITALIA
Latvia - LAKIFA
Lithuania - LIKOCHEMA
Luxembourg - DETIC
Netherlands - NCV
Norway – KLF
Poland - PACHCP
Poland - PUCI
Portugal - AIC
Romania - RUCODEM
Russia - APCoHM
Russia - PCAR
Serbia - KOZMODET
Slovakia -SZZV
Slovenia - KPC
Spain -STANPA
Sweden - KTF
Switzerland - SKW
Turkey - KTSD
United Kingdom -CTPA
Cosmetics Europe’s Vision, Mission, Goals
Vision
The cosmetics, perfumery and personal care industry and products contribute
significantly to individual and social well-being in everyday life.
Mission
Cosmetics Europe’s mission is to support the development of an innovative,
sustainable, competitive and respected cosmetics industry in Europe, which
best serves consumers.
Goals
As the single, recognised voice of European cosmetics, perfumery and
personal care, Cosmetics Europe must:
 Earn public trust
 Achieve effective public policy
 Enhance member value
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Overview:
• Cosmetics Europe The Personal Care Association
• EU and international trends triggering
review of ingredients’ safety
• Mistakes in Ingredients Annexes
• Why preservatives need to be preserved?
• Challenges with the EU approach on CMRs
• Recent regulatory developments
• Overview of the recent SCCS opinions and pending
requests
• Reflection on the coming year(s)
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
EU and international trends triggering
review of ingredients’ safety
- New scientific studies
- New technologies
- Changes in market behaviour and consumer
expectations (natural vs. high tech)
- Environmental concerns
- Horizontal regulations
- Cross -fertilisation between regions
- Mistakes in Annexes to the Cosmetics Regulation
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Overview:
• Cosmetics Europe The Personal Care Association
• EU and international trends triggering
review of ingredients’ safety
• Mistakes in Ingredients Annexes
• Why preservatives need to be preserved?
• Challenges with the EU approach on CMRs
• Key ingredients under the spotlight
• Recent regulatory proposals
• Overview of the recent SCCS opinions and pending
requests
• Reflection on the coming year(s)
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Ingredients in EU cosmetics legislation
Cosmetics Regulation (1223/2009/EC)
Negative list:
Prohibited ingredients (Annex II)
Ingredients authorised under certain restrictions and
conditions - including hair dyes (Annex III)
Positive lists:
- Authorised colorant ingredients (Annex IV)
- Authorised preservatives (Annex V)
- Authorised UV-filters (Annex VI)
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Congrès Parfums & Cosmétiques – Chartres
Mistakes in Ingredients Annexes
The transition of Cosmetics Directive to
Cosmetics Regulation
- made existing mistakes visible
- created new mistakes (factual and linguistic)
Language versions across the EU are not correct – and the
mistakes are not consistent
Creates confusion in the EU and beyond (!)
 Need urgent EU wide agreement on a correct
‘reference version’ and cascade it down in all
language versions
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Congrès Parfums & Cosmétiques – Chartres
Type of mistakes
Factual mistakes:
– changes in product categories
• e.g. toothpaste vs. oral care products
– changes in the scope of entries,
• e.g. missing or wrong EC and CAS numbers
– changes and mistakes in the labelling provisions
– deleting of substances from Annexes.
Minor mistakes
– typos
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Congrès Parfums & Cosmétiques – Chartres
Ingredients in EU cosmetics legislation
 Discrepancies between Annexes
 European
All ingredients under the
Commission work plan:spotlight…
1. Update (1st ATP)
2. Clean-up all Annexes
 EC Working Group (Member States and other stakeholders,
incl. industry)
1. Correct reference version (English)
2. Translations and work on other language versions
 Timing
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EC work expected to start in December 2014
CE will actively participate
Congrès Parfums & Cosmétiques – Chartres
Industry Approach
Cosmetics Europe reviewed the Annexes line by line
English version of Cosmetic Regulation was used as reference version for the
Annex review prepared by Cosmetics Europe
– All issues are reported:
• both serious as well as minor mistakes
• both unfounded broadening as well as narrowing of the scope
– Regulatory implementation decisions are the basis
– If needed, SCCS opinions or other reports are being consulted
– Intention is to correct mistakes only and to avoid (re)debating diverging
views
The English version would be a good basis for reviewing the other language
versions.
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Overview:
• Cosmetics Europe The Personal Care Association
• EU and international trends triggering
review of ingredients’ safety
• Mistakes in Ingredients Annexes
• Why preservatives need to be preserved?
• Challenges with the EU approach on CMRs
• Key ingredients under the spotlight
• Recent regulatory proposals
• Overview of the recent SCCS opinions and pending
requests
• Reflection on the coming year(s)
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Congrès Parfums & Cosmétiques – Chartres
Because images speak louder than words
http://www.youtube.com/watch?v=UPjoOQDyQMo
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Current Regulatory situation of
preservatives in the EU
Positive list (AnnexV): 58 entries (group entries counted as 1)
Considered as frequently used1: Less than 20
Under regulatory review over past years :
19 (9 of the preservatives considered as frequently used)
Last new applications:
– MIT (1st submission ‘02’05: included but currently
under review)
– ELA (1st submission ‘03’10: included)
– BIT (1st submission ‘04’13: lack of data, not to be
included in Annex V)
– Citric acid/silver citrate (1st submission ‘08’14:
included)
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Estimation based on currently available company information and the US/Canada voluntary reporting
system (D..C. Steinberg; Frequency of preservative use. Cosmetics and Toiletries, 2010: Vol. 125, N°11)
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Congrès Parfums & Cosmétiques – Chartres
Current Regulatory situation of
preservatives in the EU
Critical point reached for industry:
- Increasingly difficult to adequately preserve the wide
range of products
- Augmented use of a very limited number of broadly
used preservatives (broad spectrum)
Increase in exposure (individual and /or
population)
Possible, increase in the incidence of health
concerns for consumers
Safety debate on the remaining preservatives and
possible further reduction of available palette
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Congrès Parfums & Cosmétiques – Chartres
Current Regulatory situation of
preservatives in the EU
- Need for EU and global strategy to maintain
and possibly increase the palette of suitable
preservatives available to industry
- Different pillars (risk assessment, risk
management, communication)
- Actors: Industry, policy makers, regulators,
scientific/medical world, consumer associations
and media
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Congrès Parfums & Cosmétiques – Chartres
Case study
Methylisothiazolinone- broad spectrum preservative, effective at high range of pH
SCCNFP (Scientific Committee on Cosmetic Products and on Non Food Products
Intended for Consumers) composed of leading EU scientists and dermatologists
opinions from 2003 and 2004 with the following conclusion:
“ Use of MIT as a preservative at a maximum concentration of 0.01% (100 ppm) in the
finished cosmetic product does not pose a risk to the health of the consumer”
-prevalence
Actions taken toMIT
address
the issue: in newly marketed products
1200
Industry- Dec 13 - Cosmetics Europe self-regulation to stop the use of MIT in leave-on
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skin products
800
Jun 14- Submission to SCCS to support the safety of MIT in rinse-off and
hair leave-on products
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Number
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EC Authorities:
products
400
- SCCS opinion 2013- MIT safe for use in rinse –off products at 15pmm. No
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data to assess whether at higher level it is also safe.
0 - EC regulatory proposal to ban skin leave-on products currently under
2005
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2010
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2012 2013 (Oct)
discussion
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Overview:
• Cosmetics Europe The Personal Care Association
• EU and international trends triggering
review of ingredients’ safety
• Mistakes in Ingredients Annexes
• Why preservatives need to be preserved?
• Challenges with the EU approach on CMRs
• Key ingredients under the spotlight
• Recent regulatory proposals
• Overview of the recent SCCS opinions and pending
requests
• Reflection on the coming year(s)
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
EC approach to CMRs
Substances classified as CMR (Article 15 (1) and (2))
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Applicable as from 1 December 2010
New element: exemption for CMR 1A and 1B possible
(additional exemption criteria)
How are CMR classified substances regulated in Cosmetics
Regulation?
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Subject to automatic ban: not regulated in Cosm. Reg.
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Need to follow CLP Regulation 1272/2008/EC (Annex VI)
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Registry of intentions, Dossiers submitted, On-going public
consultations on harmonised classification and labelling
The list of substances banned for use in cosmetic products
Congrès Parfums & Cosmétiques – Chartres
EC approach to CMRs
Implementation of CMR related provisions
 European Commission work finalized
 Commission guidance on aggregate exposure assessments
(art.15.3)
 Industry has had discussions with DG Sanco on process
and timelines under the current interpretation of EC
 Informal agreement on evaluation process with deadlines for all
stakeholders
 Initiation of defence work on ingredients needed before
classification is adopted!
Can we expect many « CMR cases »?
What are the learnings from first cases studies?
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Congrès Parfums & Cosmétiques – Chartres
CMRs cases:
• PHMB
• Formaldehyde
• TPO
• cis-CTAC
• Boric acid and boron compounds
• D4
 On the basis of first concrete cases, industry sees a strong need to
have further discussions with COM on the interpretation and
implementation of the CMR related provisions in the CPR
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Overview:
• Cosmetics Europe The Personal Care Association
• EU and international trends triggering
review of ingredients’ safety
• Mistakes in Ingredients Annexes
• Why preservatives need to be preserved?
• Challenges with the EU approach on CMRs
• Review of recent regulatory developments
• Overview of the recent SCCS opinions and pending
requests
• Reflection on the coming year(s)
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Recently adopted regulatory measures
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Alkyl (C16, C18, C22) trimethylammonium chloride
Citric acid and silver citrate
MCI/MI
Parabens (iso, 3 long chain)
Parabens (propyl/butyl)
Polidocanol
Triclosan
Tris-biphenyl triazine (incl. nano)/ ETH 50
Several hair dyes
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Congrès Parfums & Cosmétiques – Chartres
Ingredients dossier in the EU regulatory process:
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3-benzilydene camphor
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Dichloromethane
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Methylisothiazolinone (MIT)
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Climbazole
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Potassium hydroxide (KOH)
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Zinc oxide (nano) and carbon black (nano)
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Titanium dioxide (nano)
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Quaternium-15
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Boric acid and borates (incl. perborates)
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TPO
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DEGEE
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Kojic acid
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Overview:
• Cosmetics Europe The Personal Care Association
• EU and international trends triggering
review of ingredients’ safety
• Mistakes in Ingredients Annexes
• Why preservatives need to be preserved?
• Challenges with the EU approach on CMRs
• Key ingredients under the spotlight
• Review of recent regulatory developments
• Overview of the recent SCCS opinions and pending
requests
• Reflection on the coming year(s)
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Overview of recent SCCS opinions on ingredient safety
Since November 2013, the SCCS issued a total of 30 opinions of which 8 hair dye related and 4 on nano materials.
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27 March 2014 - Opinion on Trimethylbenzoyl diphenylphosphine oxide (TPO)
27 March 2014- Opinion on Potassium hydroxide (KOH) as callosity softener/remover
27 March 2014 - Revision of the opinion on Methylisothiazolinone (P94) Submission II (Sensitisation only)
3 May 2013 Opinion on Parabens - Updated request for a scientific opinion on propyl- and butylparaben 18
June 2013- Opinion on 3-Benzilydene camphor (S61)
18 June 2014 - Opinion on the safety of PHMB in cosmetic products
18 June 2013-Revision of the addendum to the opinion of Climbazole (P64) (Preservatives)
18 June 2013- Revision of the opinion of on Diethylene Glycol Monoethyl Ether (DEGEE) (Preservatives)
11 November 2013 - Opinion on Thioglycolic Acid and its salts (TGA)
12 December 2013- Revision of the opinion on Ethyl Lauroyl Arginate HCl - submission IV (P95)
12 December 2013 - Opinion on the safety of Boron Compounds in cosmetic products
18 June 2014- Revision of the opinion on the safety of Aluminium in cosmetic products
18 June 2014- Revision of the opinion on Zn Pyrithione (P81)
23 September 2014- Revision of the opinion on HAA299 as UV filter in sunscreen products
23 September 2014- Revision of the opinion on Peanut oil (sensitisation only)
22 October 2014- Revision of the opinion on Hydrolysed Wheat Proteins - Sensitisation only
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Overview of pending mandates to the SCCS
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3 mandates on nano ingredients (Hydroxyapatite (nano), Silica (nano), Hydrated
Silica(nano), Silica Sylilate, Silica Dimethyl silylate (nano), Clarification on the
"sprayable applications" for the nano forms of Carbon Black CI 77266, Titanium
Oxide and Zinc Oxide)
3 fragrance ingredients (Tagetes minuta and T. patula extracts and essential oils
(phototoxicity only), 2~(4-tert butylbenzyl) propionaldehyde (BMHCA), Vetiveryl
acetate)
4 preservatives (Phenoxyethanol, Cetylpyridinium chloride (No P97), Preservative
EcoG+, o-Phenylphenol, Sodium ophenylphenate, Potassium o-phenylphenate,
MEA o-Phenylphenate)
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1 UV-filter- Phenylene Bis-Diphenyltriazine,
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5 Others - Ethyl Lauroyl Arginate HCl (ELA) , formaldehyde in nail hardeners,
Cyclopentasiloxane (D5), Vitamin K1 Oxide, Arbutin)
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7 hair dyes
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Overview:
• Cosmetics Europe The Personal Care Association
• EU and international trends triggering
review of ingredients’ safety
• Mistakes in Ingredients Annexes
• Why preservatives need to be preserved?
• Challenges with the EU approach on CMRs
• Key ingredients under the spotlight
• Review of recent regulatory developments
• Overview of the recent SCCS opinions and pending
requests
• Reflection on the coming year(s)
20-11-2014
Congrès Parfums & Cosmétiques – Chartres
Reflection on the coming year(s)
New team of Commissioners impact on key policy directions
Possible increase in ingredient reviews triggered by
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chemicals legislation (CLP/REACH)
environmental/sustainability concerns
criteria for identification of chemicals with possible ED properties
borderlines and scope
vulnerable populations
international harmonization
Expected high profile ingredient discussions:
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aluminium
MIT
fragrance allergens
hair dyes
nano ingredients
traces of unwanted substances (international dimension)
Congrès Parfums & Cosmétiques – Chartres
Merci de votre attention
20-11-2014
Congrès Parfums & Cosmétiques – Chartres