Tiêu Chuẩn Iso Tr 19838-2016.Pdf

© ISO 2016 Microbiology — Cosmetics — Guidelines for the application of ISO standards on Cosmetic Microbiology Microbiologie — Cosmétique — Lignes directrices pour l’application des normes ISO relativ[.]

Microbiolog y — Cosmetics —

Micro iolo ie — Cosmétique — Lignes directrice s p ur l’a plication

des n rme s ISO re latives à la mic ro iolo ie cosmétique

Fir t edition

2 16-0 -1

COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, P blshed in Sw itz rlan

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or b an me ns, ele tr onic or me hanic l, inclu in p oto opying , or postin on the internet or an intranet , w ithout prior

written permis ion Permis ion c n be req esed from either ISO at the ad r es below or ISO’s member bod y in the c u try of

F reword i v

Introduction v

1 Sc ope 1

2 Terms an definitions 1

3 Micr obial c ontent 2

3.1 General r eq ir ements 2

3.2 En mer ation of meso hi c microor ganisms (b cte ia, yeas s an moulds) 3

3.3 Dete tion of spe ified microor ganisms 3

3.4 Dete tion of spe ified an non-spe ified microor ganisms 4

4 A ntimicrobial preser vation 5

4.1 General r eq ir ements 5

4.2 Ev luation of the pr ese v tion of a cosmetic formulation 5

4.3 Ev luation of the pr ese v tion of a cosmetic pr od ct 6

5 Examples of micr obial c ontent results 6

5.1 General 6

5.2 Eye make-up remo e 6

5.3 Mascara 6

5.4 Fac cr eam 7

5.5 Shampo 8

6 Examples of interpretation of preser vatio eficacy test sults 8

A nne x A (informative)Relatio ship betwe n the ISO c osmetic micr obiolog y standards 11

A nne x B (informative)Relatio ship betwe n the ISO standards de lng w ith the microbial c ontent of c osmetic 12

A nne x C (informative) E aluation of the micr obial c ontent of a c osmetic pr oduct 13

A nne x D (informative) Interpretatio of test r esults 14

Biblog raphy .15

ISO (he Int ernational Org nization for Stan ardization) is a worldwidefede ation of national s an ards

b dies (ISO membe b dies) The work of pr p ring Int ernational Stan ards is normaly car ied out

through ISO t ech ical committ ees Each membe b dy int er st ed in a subje t for w hich a t ech ical

committ ee has be n es a lshed has the right t o be r pr sent ed on that committ ee Int ernational

org nizations, g overnmental an non-g ove nmental, in laison with ISO, also take part in the work

ISO cola orat es closely with the Int ernational Ele trot ech ical C mmis ion (IEC) on al matt ers of

ele trot ech ical s an ardization

The proc d r s used t o develo this document an those int en ed for it furthe maint enanc ar

desc ibed in the ISO/IEC Dir ctives, Part 1 In p rticular the dife ent a pro al c it eria ne ded for the

dife ent ty es of ISO document should be not ed This document was draft ed in ac ordanc with the

edit orial rules of the ISO/IEC Dir ctives, Part 2 ( e www.iso.org dir ctives)

A tt ention is drawn t o the p s ibi ity that some of the element of this document ma be the subje t of

p t ent right ISO shal not be held r sponsible for identifying any or al such p t ent right Detais of

any p t ent right identified d ring the develo ment of the document wi be in the Introd ction an / r

on the ISO ls of p t ent de larations r c ived ( e www.iso.org p t ent )

Any trade name used in this document is information given for the convenienc of use s an does not

cons itut e an en orsement

F or an ex lanation on the meaning of ISO spe ific t erms an ex r s ions r lat ed t o conformity

as es ment, as wel as information a out ISO’ s adhe enc t o the WTO principles in the Te h ical

Bar ie s t o Trade (TBT) se the fol owing URL: F or word - Sup lementary information

The committ ee r sp nsible for thisdocument is ISO/TC2 7, Cos metic s

Eve y cosmetic man factur r has a d al r sp nsibi ty r lative t o the mic o iolo ical q alty of it

prod ct

— The firs is t o ensur that the prod ct, as pur hased, is fr e from the n mbe s an ty es of

mic o rg nisms that could afe t prod ct q alty an consume health This is g ene aly ensur d

b a plying cosmetic g ood man facturing practic (GMP) ( e ISO 2 7 6) d ring the man facturing

an packa ing o e ations an , if ne es ary, b using mic o ial co tent tests on finished prod ct

— The se on is t o ensur that mic o rg nisms introd c d d ring normal prod ct use wi l not

adve sely afe t the q alty or safety of the prod ct This is g ene aly ensur d b cond cting

preservatio ef icacy tests (or chaleng e tests) d ring the develo ment tag e of the new prod ct

In orde t o ensur prod ct q alty an safety for consume s, it is advisa le that an a pro riat e

mic o iolo ical risk analysis be pe formed t o det ermine the ty es of cosmetic prod ct t o w hich this

Te hnical R ep rt would be a plca le

— Prod ct conside ed t o pr sent a low mic o iolo ical risk ar desc ibed in ISO 2 6 1 These

prod ct identif ied as “hos ie” an prod c d in compl anc with GMP pose a ve y low o e al risk

t o the use The efor , prod ct that comply with the charact eris ics outlned in ISO 2 6 1 do not

r q ir mic o iolo ical t es ing inclu ing b th chal eng e t es an end prod ct t es ing

— F or those prod ct w hich ar not conside ed “hos i e” , the mic o iolo ical q alty has t o be

as es ed b con ucting t es s with a pro riat e methods ISO TC 2 7 pro ides a compr hensive set

of s an ards t o as es the antimic o ial pr se v tion ofcosmetic prod ct an the mic o iolo ical

q alty of f inished prod ct (methods an l mit ) Man factur rs can de ide not t o t es if they can

demons rat e that their prod ct comply with those r q ir ment spe if ied in ISO 1 5 6 an / r

ISO 1 9 0

Microbiolog y — Cosmetics — Guidelines for the

This Te h ical R ep rt gives g ene al guidelnes t o ex lain the use of ISO cosmetic mic o iolo ical

s an ards depen ing on the o je tive ( in-market control, prod ct develo ment, et c ) an the prod ct

t o be t est ed

This Te hnical R ep rt can be used t o fulf il the r q ir ment of the ISO s an ard on mic o iolo ical

l mit (ISO 1 5 6)

2 Terms and definitions

F or the purposes of this document, the folowing t ermsand definitions a ply

finished cosmetic prod ct that has u de g one al s ag es of prod ction, inclu ing p cka ing in it f inal

containe for shipment

2.3

sample

one or mor r pr sentative element sele t ed from a set t o o tain information a out that set

2.4.1

mic o ial co tent

<q antitative> es imat ed n mbe of via le ae o ic meso hi c mic o rg nisms (b ct eria, yeas s an

moulds) within a cosmetic

2.4.2

mic o ial co tent

<q altatative> det ecta le spe if ied or non-spe if ied mic o rg nisms within a cosmetic sample

2.5

preserv atio of a cosmetic formulation

set of means used t o a oid mic o ial prolfe ation in a cosmetic formulation

E AMP E Preservatives, multifu ctionalcompou ds, hostile raw materials, e treme pH, low water activity

values, et c

2.6

antimic o ial prot ectio of a cosmetic prod ct

a i ity of a cosmetic prod ct t o o e come mic o ial contamination that might pr sent a p t ential risk

t o the use

Note 1 t o entry: T e overal antimic o ial protection inclu es preservation of the formulation, the specif ic

man facturing proces an protective packa ing

2 7

mic o iologicaly low-risk prod cts

prod ct w hose environment denies mic o rg nisms the phy sical an chemical r q ir ment for

growth an / r surviv l (hos i e prod ct )

Not e 1 t o entry: T is cate ory of low-risk prod cts ap lies to mic o iolo ical contamination which may oc ur

d ring man facturing an / r use by the consumer

Not e 2 to entry: A prod ct whose packa ing prevents the ingres of mic o rg nisms is considered a

mic o iolo ical low-risk prod ct d ring its use

Not e 3 t o entry: T e inclusion of preservatives or other antimic o ial compou ds in a formulation by itself would

not neces arily constitute a low-risk prod ct

2.8

mic o iological Risk As es ment (low risk prod cts)

ev luation of prod ct charact eris ics t o det ermine if that prod ct ma be subje t t o mic o ial

contamination

Not e 1 t o entry: T ese characteristic inclu e the composition of the prod ct, the prod ction con itions,

packa ing an a combination of these factor (se ISO 2 62 )

A dditional y, ISO 2 148 gives g ene al ins ructions for car ying out mic o iolo ical ex minations of

cosmetic prod ct

Be ause of the larg e v riety of cosmetic prod ct within this field of a pl cation, the methods desc ibed

in theseInt ernational Stan ards ma not be a pro riat e for some prod ct in eve y detai (e.g c rtain

wat er immiscible prod ct )

Othe methods (e.g aut omat ed) ma be subs itut ed for the t es s pr sent ed he e pro ided that their

eq iv lenc hasbe n demons rat ed or the method has be n othe wise ve ified

The pos ible inhibition of mic o ial growth b the sample should be neutral z d t o alow the det ection

of via le mic o rg nisms In al cases an w hat eve the methodolo y, the neutral zation of the

antimic o ial pro e tiesof the prod ct should be che ked an demons rat ed

The s u y of the neutral zation ofthe antimic o ial a ctivity should be pe formed when the tes s ha e to

be car ied out on new prod ct an wheneve the e is a change in the ex e imental con itions of the tes

The given Int ernational Stan ards wi l alow the folowing:

— the en me ation an det ection of meso hi c mic o rg nisms w hich ma grow u de ae o ic

conditions;

— the det ermination of the a senc of spe ified mic o rg nisms that ar of int er s for cosmetic

prod ct ;

an , the efor , t o es imat e if the prod ct u de t es comples with the r q ir ment of the Int ernational

Stan ard on mic o iolo ical lmit (ISO 1 5 6)

The t es methods ar desc ibed in the in ivid al s an ards The choic of a spe ific method, or

combination of methods, wi l depen on the purp se for pe forming the t es It is up t o the use t o

de ide w hich a pro ch is bes for each a plcation

Depen ing on the ex e t ed level of contamination of the sample t o be t est ed, two dife ent a pro ches

can be used ( e An ex A)

— Quantitative t es s (en me ation)ar t o be used w hen the e is no information on the mic o iolo ical

q alty of the sample or if it is ex e t ed t o be contaminat ed

— Qualtative t es s (det ection) can be used if the sample is pr suma ly fr e from mic o ial

contamination (e.g based on prod ct hist ory) an can be ve y useful from an e onomical an

prod ction time s an point

In the event w he e mic o rg nisms ar det ect ed, the pr senc of spe if ied mic o rg nisms should be

che ked ac ording t o 3.3 or 3.4

3.2 Enumeration ofmesophi ic microor ganisms (bacter ia, ye sts and moulds)

F or b ct eria, the en me ation method desc ibed in ISO 2 149 inv lves en me ation of colonies on a

non-sele tive a ar medium En me ation of colonies can be pe formed b a plat e count method or a

filtration method using a spe if ied cultur medium incub t ed u de defined conditions

The r sult ar ex r s ed as folow s:

“[n mbe of] ae o ic meso hi ic b ct eria pe gram or pe mi i itr of prod ct, ex r s ed as cfu/

or cfu/ ml”

F or yeas s an moulds, the method desc ibed in ISO 1 2 2 inv lves en me ation of colonies b a plat e

count method or a f iltration method using a spe ified cultur medium with antibiotic incub t ed un e

def ined con itions

An alt ernative con ition using thecultur medium without antibiotic is pro osed in ISO 1 2 2

The r sult ar ex r s ed as folow s:

“[n mbe of]yeas an mould pe gram or pe mi i tr of prod ct ex r s ed, as cfu/ or cfu/ml”

3.3 Detection of specified micr oor ganisms

The det ection of skin p thog ens such as Sta h loc occ us a r us , Ps eudomo as ae u in s a an Ca dida

albic ans ma be r lev nt The det ection of othe kin s of mic o rg nisms might be of int er s sinc

these mic o rg nisms ( inclu ing indicat ors of fe al contamination e.g Esche ichia c ol sugg es hy gienic

faiur d ring the man facturing proc s

The methods ar desc ibed in ISO 1 41 (C.albic ans), ISO 2 1 0 ( E c ol ISO 2 7 7 (P aerugin s a), an

ISO 2 7 8 (S.a r us)

The main st eps of the methods ar the folowing:

— an enrichment using a non-sele tive broth medium incub t ed u de def ined con itions t o inc ease

the n mbe of mic o rg nisms w hie a oiding the risk of inhibition b the sele tive ingr dient

pr sent in sele tive /dife ential growth media;

— then, if growth is det ect ed, an isolation on a sele tive medium folowed b identification t es s

If the identif ication of the coloniesconfirmsthe pr senc of the spe ified mic o rg nism (Sta h loc oc c us

a r us , Pseudomo as aerugin s a, Ca dida albic ans or Esche ichia c ol the r sult is ex r s ed as folow s:

“ Pr senc of the spe if ied mic o rg nism (n me o the s pec ies) in the sample S.”

If no growth aft er enrichment is o se ved an / r if the identification of the colonies does not con rm

the pr senc of the spe if ied mic o rg nism (Sta h loc occ us a r us , Ps eudomo as aerugin s a, Ca dida

albic ans or Es che ichia c ol), the r sult is ex r s ed as folow s:

“Absenc of the spe if ied mic o rg nism (n me o the s pec ies) in thesample, S.”

3.4 Detection of specified and non-specified microor ganisms

Two Int ernational Stan ards desc ibe how t o det ect pe if ied an non-spe ified mic o rg nisms

— The principle of ISO 1 41 is t o pe form an enrichment b using a non-sele tive broth incub t ed un e

defined con itions t o inc ease the n mbe of mic o rg nisms without the risk of in ibition b the

sele tive ingr dient that ar pr sent in sele tive /dife ential growth media folowed b isolation on

a non-sele tive medium incub t ed u de defined con itions and identification con uct ed ac ording

t o ne d b using a pro riat e incub tion con itions an suita le identification t es s

F or each spe ies of spe if ied mic o rg nism, an if the identif ication of the colonies con rms the

pr senc of this spe ies, the r sult isex r s ed as folow s:

“Pr senc of (n me o the s pec ies) in the sample, S”

If growth is o se ved aft er enrichment an if the colonies ar isolat ed an r co niz d as

non-spe if ied mic o rg nisms, the r sult is ex r s ed as folow s:

“ Pr senc of (n me o the s pec ies or main morpholo ical charact eris ics) in the sample, S, an

a senc of spe ified mic o rg nisms”

If no growth aft er enrichment is o se ved, the r sult is ex r s ed as folow s:

“Absenc of ae o ic meso hi ic bact eria an yeas ( pe ified mic o rg nisms inclu ed) in the

sample, S”

— ISO 2 149 desc ibes a method for the det ection of ae o ic meso hi c b ct eria

The enrichment method desc ibed in ISO 2 149 consis s ofincub tion u de def ined con itions

of a defined q antity of the sample (S) in a non-sele tive broth containing suita le neutral z rs

an / r dispe sing ag ent folowed b a trans e of a def ined q antity of the pr vious suspension on

non-sele tive sold a ar medium u de defined con itions The dife enc betwe n ISO 1 41 an

ISO 2 149 is that the neutral zation of the antimic o ial activity in ISO 2 149 is only che ked for

bact eria, w hie ISO 1 41 r fe s t o b th b ct eria an yeas

The efor , if no growth aft er enrichment is o se ved, the r sult ar ex r s ed as folows:

“Absenc of ae o ic meso hi ic b ct eria ( pe if ied b ct eria inclu ed) in the sample S

If growth is o se ved aft er enrichment, the r sult ar ex r s ed as:

“Pr senc of ae o ic meso hi c b ct eria in the sample S

NOT E richment methods are not ap ropriate ( emperature, culture media) t o detect moulds.

Therefore, even if no growth aft er enrichment is o served, it is neces ary to lo k for moulds using

ap ropriate culture con itions (se ISO 162 2)

4 A ntimicrobial preserv tion

4.1 General requir ements

The antimic o ial prot ection of a cosmetic prod ct (cosmetic formulation in it f inal containe ) can

come from many sour es, such as the folowing:

— chemical pr se v tion;

— inhe ent charact eris ics of the formulation;

— packag edesign;

— man facturing proc s

When ev luating the o e al antimic o ial prot ection of a cosmetic prod ct, these dife ent sour es

should be taken int o ac ou t in a mic o iolo ical risk as es ment

ISO 1 9 0 desc ibes a proc d r for the int erpr tation of data g ene at ed b the pr se v tion eff icacy

t es ( if a pro riat e) and b the mic o iolo ical risk as es ment

4.2 Evaluation of the preservation ofa cosmetic for mulation

A pr se v tion efficacy t es or chaleng e t es is commonly used t o ev luat e the pr se v tion of a cosmetic

formulation This t es is not r q ir d for those cosmetic prod ct for w hich the mic o iolo ical risk has

be n det ermined t o be low ( e ISO 2 6 1)

This t es is primari y designed for wat er-soluble or wat er-miscible cosmetic prod ct an can r q ir

ada tation, for ex mple, t o t es prod ct in w hich wat er is the int ernal phase The t es desc ibed in

ISO 1 9 0 inv lves, for each t es mic o rg nism, placing the formulation in contact with a calbrat ed

inoculum, an then measuring the chang es in the mic o rg nism cou t at set time int erv ls for a set

pe iod an at a set t empe atur

As for the mic o ial cont ent t es s, the p s ible in ibition of mic o ial growth b the sample should be

neutralz d t o alow the det ection of via le mic o rg nism In al cases an w hat eve the methodolo y,

the neutralzation of the antimic o ial pro e ties of theprod ct should be che ked an demons rat ed

The mic o rg nism cou t ar conve t ed in lo r d ction v lues an comp r d with 2 set of c it eria

ex r s ed as minimum lo r d ction

— Crit eria A, w he eb the formulation is prot ect ed a ains mic o ial prolfe ation that ma pr sent a

pot ential risk for the use an no ad itional fact ors ar conside ed

— Crit eria B, w he eb the level of prot ection is ac epta le if the risk analy sis demons rat es the

exist enc of control fact ors not r lat ed t o the formulation in icating that the mic o iolo ical risk is

t ole a le for the cosmetic prod ct

The in e ent v ria i ty in mic o ial cou t should be taken int o conside ation w hen comp ring the

o tained v lues an the pr set c it eria A or B A deviation of 0,5 lo unit from the pr set c it eria is

conside ed ac epta le