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PCPC Annual Science Symposium October 2013, Newark

Preservatives

EU Regulatory Landscape and Safety

Overview

Evelyn Coelis

Issue Manager Technical Regulatory Affairs

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Content

• Cosmetics Europe The Personal Care

Association

• Preservatives in EU Cosmetics Regulation and

general state-of-play

• Preservatives under the spotlight – safety and

regulatory status

• Conclusions

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In Brief

Cosmetics Europe is the European trade

association representing the interests of the

cosmetics, toiletry and perfumery industry.

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Corporate Members

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National Associations

• 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 - UNIPRO

• Latvia - LAKIFA

• Lithuania - LIKOCHEMA

• Luxembourg - DETIC

• Netherlands - NCV

• Norway – KLF

• Poland - PACHCP

• Poland - PUCI

• Portugal - AIC

• Russia - APCoHM

• Russia - PCAR

• Romania - RUCODEM

• Serbia - KOZMODET

• Slovakia -SZZV

• Slovenia - KPC

• Spain -STANPA

• weden - KTF

• Switzerland - SKW

• Turkey - KTSD

• United Kingdom -CTPA

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Correspondent Members

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International collaboration

• Lowering trade barriers

• Bilateral and multilateral

• Different levels (FTAs (TTIP), ICCR, ISO)

https://www.cosmeticseurope.eu

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II. Preservatives in the EU Cosmetics

Regulation & General State-of-Play

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Anything new?

Preservation:

• Adequate product preservation

• Annex I – Cosmetic Product Safety Report – Part

A.3 Microbiological requirements (incl. results of

preservation challenge test)

– Only what, no guidance on how

– ISO EN standards (EN ISO 29621:2010; EN ISO 11930:2012

Preservatives:

• Positive list (Annex V) – Primary fuction product

preservation

• Application process for new preservatives

Definition: “substances which are exclusively

or mainly intended to inhibit the development

of microorganisms in cosmetic products”

Some guidance on germ limits and efficient

preservation testing in SCCS Notes of Guidance

(Dec. 2012)

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Other relevant EU Regulatory schemes

• Biocidal Products Regulation

– New regulation applicable (Sept. ‘13)

– Cosmetic products exempted

• REACH

– Hazard based, risk considerations only at 2nd

stage

– Cosmetic products use exempted for human

safety related measures

• CLP

– Hazard, human & environmental safety

– Link with Cosmetics Regulation (Art. 15 – CMR)

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Current state-of-play

• Annex V: 54 entries

• Frequently used1: 12

• Under regulatory review over past years :

19 (9 of the 12 frequently used)

• Last new applications:

– MIT (1st submission ‘02’05: included but currently under

review)

– ELA (1st submission ‘03’10: regulated)

– BIT (1st submission ‘04’13: lack of data, ban expected)

– Citric acid/silver citrate (1st submission ‘08’13: regulation

expected)

• Multi functional ingredients

1D.C. Steinberg; Frequency of preservative use. Cosmetics and Toiletries, 2010: Vol. 125, N°11

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III.Preservatives under the spotlight –

Safety and Regulatory Status

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Parabens – lineair chain Most recent SCCS opinion and consequences

• SCCS assessment of lineair chain parabens re-opened due

to new data (repr. tox) and Member State concern

Revised SCCS opinion (adopted in May 2013)

Main SCCS conclusions unchanged:

Methyl and ethyl paraben remain safe as used.

Propyl and butyl paraben: use levels should be reduced to 0.19 %

expressed as ester.

Regulatory process restarted (proposal and public consultation

(deadline for comments 1 Nov. ‘13)

CE comments (transition period and expression of conc.)

Adoption of regulation expected in Feb ‘13

In the absence of sufficient information on the metabolism of

parabens in humans, which differs significantly from the rodent

metabolism, the SCCS can not revise its conclusions on maximum

use levels.

The current way of assessing the exposure to sunscreens is

sufficiently protective for all age groups. The SCCS also

emphasised that small children up to six months should not be

exposed to direct sunlight at all.

http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/parabens/parabens_pc_en.pdf

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Parabens (2) Ban of five parabens

• Scope: isopropyl-, isobutyl-, benzyl-, phenyl-,

and pentyl paraben

• Ban adopted on 10 Oct ‘13

• Expected publication of the legislation: ~ Feb ’14

Transition periods:

For new products: date of publication + 20d

+ 6 months

For existing products: date of publication

+ 20d + 15 months

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Phenoxytehanol

Regulated in cosmetics: Annex V, 29 (max. conc. 1.0%)

• Re-evaluation of safety by French Health Authorities, focus:

children < 3 years

Recommendation of French authorities: (i) Ban of use in

products for nappy zone, (ii) Max. conc. Of 4.0% in all other

products for children < 3 years

EC follow up:

Stakeholders call for data (deadline: 8 Dec. ’13)

Mandate to SCCS to evaluate safe use (expected in Dec. ‘13)

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Phenoxytehanol (2)

CE position and approach:

French assessment (i) not in accordance with EU (SCCS)

requirements for baby safety assessments and (ii) based on

outdated safety data

Preparation (by CE interested parties group) of complete safety

dossier for submission to EC/SCCS

Based on correct safety assessment approach and latest

available safety data: No safety concern, all current use can be

supported

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Methylisothiazolinone (MIT)

Regulated in cosmetics: Annex V, 57 (max. conc. 0.01%)

Relatively recent (2005)

• Recent clinical data showing increase in positive patch

test reactions to MIT in patients with dermatitis

• Request by Member States and dermatologists to re-

evaluate safe use of MIT

EC follow-up:

Sept. ‘13 - Mandate to SCCS to re-evaluate current use based

on clinical data, SCCS opinion due in Dec ‘13

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Methylisothiazolinone (MIT) (2)

CE position and approach:

• Assess clinical data (indication only) and determine

relevant risk management measures (primary, secondary

prevention)

• Based on available risk assessment assessment tools

(QRA), certain applications cannot be supported

• Engage in discussions with dermatologists, present

industry approach and work towards joint solution

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Relation preservatives - allergy

Dillarstone effect

P1

Prevalence of

contact dermatitis

Use cycle of

Preservatives

P2

C1

C2

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Formaldehyde

Regulated in cosmetics (Preservative (Annex V, 5): max. conc. (free

FA) 0.1% in oral care, 0.2% in other products, prohibited in aerosol

products, labelling requirement > 0.05% and Nail hardeners (Annex III,

13): max. conc. 5%, use instruction and labelling)

• Reclassification (CMR Carc. Cat. 1A) - 5th ATP to CLP (application

date: Jan ’15)

Under EUCosReg (Art. 15.2): Automatic ban unless exemption

criteria fulfilled

Lack of suitable alternatives

Naturally present in food or regulated in EU Food Legislation

Evaluated and found safe by SCCS (incl. aggregate exposure

assessment)

CE interested parties group – support of released FA coming from

current use of FA releasing preservatives (0.05 % (free FA)) and use of

FA in nail hardeners (2.2% (free FA))

Formaldehyde (CAS 50-00-0),

not the FA releasing

preservatives

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Polyaminopropylbiguanide

Regulated in cosmetics (Annex V, 28): max. conc.

0.3%)

• Classification (CMR Carc. Cat. 2) - 6th ATP to

CLP (application date: April ‘15)

Under EUCosReg (Art. 15.1): Automatic ban

unless exemption criterion fulfilled Evaluated and found safe by SCCS

CE interested parties group – support of current

use except use in aerosol products

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And…

Substance Status in EU

Benzoic acid Human health, proposal for harmonised classification (not CMR)

Benzyl alcohol Considered as a potential fragrance allergen

BIT Application for preservative use, SCCS review and unfavourable

opinion (sensitisation, also non-preservative use), adoption of

ban awaited

Cetyl Pyridinium

Chloride

Application for use as preservative (antimicrobial use, oral care).

SCCS opinion awaited.

Chloroacetamide CMR, SCCS review and unfavourable opinion (not supported,

lack of data), adoption of ban awaited

Chlorphenesin,

chlorhexidine)

Regular media/NGO attention in Northern Europe

Cis-CTAC CMR 2 class., SCCS review and unfavourable opinion (Dec. ‘11).

Cis-CTAC considered as banned. Still to be delisted.

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And… (2)

Status in EU

Citric acid/silver citrate Application for use as preservative and active in deodorant and

APs, SCCS review and favourable opinion (‘09), adoption of

regulation awaited.

Climbazole Additional non preservative use (foot care); SCCS review (cross-

resistance, borderline) and favourable opinion (Feb ‘13);

regulatory follow-up awaited

Ethyl Lauroyl Arginate Additional use (oral care); SCCS review and opinion (Sep. ‘13)

(mouthwash only) – public consultation

Glutaraldehyde Human and environmental safety, CLP (not CMR) and BPD review

ongoing.

IPBC Regulated. Part of EC survey on iodine exposure. Harmonised

classification expected (human health not CMR)

Mercury containing

preservatives

(phenylmercury salts

and thiomersal)

Environmental safety – New Minamata Convention (Apr. ‘13)

(phase out by 2020, cosmetics > 1ppm except preservative use in

eye area)

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And… (3)

Substance Status in EU

MIT/CMIT State-of-the art submission request; SCCS review (sensitisation,

only rinse-off supported) and favourable opinion; regulation

awaited (discussion on label warning)

O-phenylphenol Human health, Member State recommendation to EC to ban

preservative, public call for data (deadline 9 Dec ‘13), SCCS

evaluation and regulation expected

Triclosan Antimicrobial resistance and alleged ED, SCCS review and

favourable opinion (acceptable reduction for mouthwash),

regulation adopted (Oct. ‘13) – EU biocides and REACH (ED)

review ongoing

4-hydroxybenzoic acid Alleged ED, included on REACH substance review list (Feb’ ’12)

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IV.Conclusions

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Conclusions

RISK PERCEPTION NGO/MEDIA ATTENTION

RISK ASSESSMENT

RISK MANAGEMENT

RISK COMMUNCIATION

POLITICAL PRESURE

RISK REDUCTION

Downwards spiral in EU

knock-on effect internationally

Consumer/ public

Health authorities/ scientific world

Heavy EU

regulatory

environment

EU animal testing ban

Free of

preservative

claims

Actions by

retailers

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Ingredients

Parabens

Citric acid and silver citrate

Acetaldehyde

Kojic Acid MCI/MI

Aluminium

Po

lido

ca

no

l H

air d

ye

s

D4/D5

EU Cosmetics Regulation

Annex I

Annex reviews

Roles &

Responsib.

Notification

CPNP

GMP

Labelling

Undesirable

effects

Claims Nanomaterials

International convergence Upstream/sidestream Regulations

Cosmetics

Regulation

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Conclusions (2)

Need for global industry « one voice »

ingredient defence strategy

– Not only « one-by-one » approach, but general

strategy

– Communication, positive messaging, vocal

industry

– Science (also independent scientists)

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Thank you for your attention