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List of Preservative Which Cosmetic Products May Contain

ANNEX VI

Preamble

1. Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.

2. The substances marked with the symbol (+) may also be added to cosmetic products in concentration other than those laid down in this ANNEX for other purposes apparent from the presentation of the products, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos.

3. Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohols. These substances are not included in the ANNEX.

4. For the purpose of this list
– “Salts” is taken to mean; salts of the cations sodium, potassium, calcium, magnesium, ammonium, and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.
– “Esters” is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.

5. All finished products containing formaldehyde or substances in this ANNEX and which release formaldehyde must be labeled with the warning “contains formaldehyde” where the concentration of formaldehyde in the finished product exceeds 0.05%

ANNEX VI – PART 1

LIST OF PRESERVATIVES ALLOWED

Colipa Number Reference Number Substance Maximum authorized concentration Limitations and requirements Conditions of use and Warnings which must be Printed on the label
  a b c d e
P2 1 Benzoic acid, its salts and esters(+) 0.5% (acid)    
P13 2 Propionic acids and salts (+) 2% (acid)    
P14 3 Salicylic acid and its salts (+) 0.5% (acid)    
P15 4 Sorbic acid (hexa-2-4-dienoic acid) and its salts (+) 0.6% (acid) Not to be use in preparation in children under 3 years of age, excepts for shampoos Not to be use for children under 3 years of age (1)
P39 5 Formaldehyde and paraformaldehyde (+) 0.2% (except for pro- ducts for oral hygiene) 0.1%(products for oral hygiene) express as free formaldehyde Prohibited in aerosol dispensers(spray)  
P47 7 Biphenyl-2-ol (o-phenylpenol) and its >salts (+) 0.2% express as phenol    
P81 8 Pyrithione zinc (NN) (+) 0.50% Authorized in products rinsed off, forbidden in products for oral hygiene  
P51 9 Inorganic sulphites and hydrogensulphites(+) 0.2% expressed as free SO2    
P 66 10 Sodim iodate 0.10% Rinse-off products  
P68 11 Chlorobutanol (INN) 0.50% Prohibited in aerosol dispensers spray Contains chlorobutanol
P82 12 4-hydroxybenzoic acids its salts and esters (+) 0.4%(acid) for ester; 0.8% (acid) for mixtures of esters    
P5 13 3-Acetyl-6-methylperan-2,4(3H)- dione (Dehydroacetic acid) and its salts 0.6% (acid) Prohibited in aerosol dispensers (spray)  
P6 14 Formic acid and its sodium salts (+) 0.5% (expressed as acid)    
P9 15 3,3′-Dibromo-4,4′-hexamethylene- dioxydibenzamidine (Dibromohexamidine)  and its salts (including isethionate) 0.10%    
P12 16 Thiomersal (INN) 0.007% (of Hg) if mixed with other mercurial compounds authorized by this Directive, the maximum concentration of Hg remains fixed at 0.007% For eye make-up and eye make-up remover only Contains thiomersal
P48 17 Phenylmercuric salts (including borate) Ditto Ditto Contains phenylmercuric compounds
P16 18 Undec-10-enoic acid and salts (+) 0.2% (acid)    
P20 19 Hexetidine (INN) (+) 0.10%    
P23 20 5-Bromo-5-nitro-1,3 dioxane 0.10% -Rinse-off products only

-Avoid formation of nitrosamines

 
P24 21 Bronopol (INN) (+) 0.10% Avoid formation of nitrosamines  
P74 22 2,4-Dichlorobenzyl alcohol (+) 0.15%    
P29 23 Triclocarban (INN) (+) 0.20% Purity criteria: 3,3′,4,4′ Tetrachloroazobenzene less than 1 ppm;3,3′,4,4′- Tetrachloroazoxybenzene less than 1 ppm  
P30 24 4-Chloro-m-cresol 0.20% Prohibited in products intended to come into contact with mucous membranes  
P32 25 Triclosan(INN) (+) 0.30%    
P37 26 4-Chloro-3,5-xylenol  (+) 0.50%    
P43 27 3,3′-Bis91-hydroxymethyl-2,5- dioxoimidazolidin 4-yl)-1,1′- methylenediurea (“Imidazolidinyl urea”) (+) 0.60%    
P52 28 Poly(1-hexamethylenebiguanide hydrochloride (+) 2-Phenoxyethanol (+) 0.30%    
P53 29   1.00%
P55 30 Hexamethylenetetramine  (+) Methenamine (INN) 0.15%    
P63 31 Methenamine 3-chloroallylochloride (INNM) 0.20%    
P64 32 1-(4_chlorophenoxy)-1-(imidazol-1yl)3,3-dimethylbutan-2-0n2 (+) 0.50%    
P65 33 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazoli- dine-2,4-dione (+) 0.60%    
P67 34 Benzyl alcohol (+) 1%    
P59 35 1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl)2- pyridon ansits monoenatholamine salt(+) 0.50% 1% For other products Products rinsed -off  
P77 36 1,2-Dibromo-2,4-dicyanobutane 0.10% Not to be used in cosmetic sunscreen products at a concentration exceeding 0.03%  
P25 37 6,6 dibromo-4,4-dichloro-2,2′-methylene-diphenol:Bromochlorophen) (+) 0.10%    
P44 38 4-Isopropyl-m-cresol 0.10%    
P56 39 Mixture of 5-Chloro-2methyl-isothiazol


3(2H) one and 2-methylisothiazol-

2-methylisothiazol-3(2H)-One) with magnesium chloride and magnesium nitrate
0.0015% (of a mixture in the ratio 3:1 of 5-Chloro-2-ethyl- isothiazol-3(2H)-one  and    
P22 40 2-Benzyl-4-chlorophenol  (Chlorophene) 0.20%    
P27 41 2-Chloroacetamide 0.30%   Contains chloroacetamide
P35 42 Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (+) 0.3% expressed as chlorxidine    
P54 43 1-Phenoxypropanpropan-2-ol 1.00% Only for rinse-off products  
P72 44 Alkyl (C12-C22) trimethyl ammonium, bromide 0.10%    
P75 45 4,4-Dimethyl-1,3-oxazolidine 0.10% The pH of the finished product must not be lower than 6  
P79 46 N-(hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolinidyl-4)-N’- (hydroxymethyl)urea 0.50%    
P8 47 1,6-Di(4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxy-benzoate (+) 0.10%    
P76 48 Glutaraldehyde (Pentane-1,5-dial 0.10% Prohibited aerosols (sprays) Contains glutaraldehyde (where glutaraldehyde concentration in the finished products exceeds 0.05%
P90 49 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane 0.30% Prohibited in oral hygiene products and in products intended to come into  
P4 50 3-(p-Chlorophenoxy)-propane-1,2-diol (chlorphenesin) 0.30%    
P84 51 Sodium hydroxymethylamino Acetate (Sodium hydroxymethylglycinate) 0.50%    
P93 52 Silver chloride deposited Titanium dioxide 0.004% calculated as AgCl 20%AgCI (w/w) on TiO2 prohibited in products for children under 3 years of a age, in oral hygiene products intended for application around the eyes and on the Lips
P70 53 Benzenthonium chloride 0.10%   Rinse-off products only
P71 54 Benzalkonium chloride, bromide, and saccharinate 0.1% calculated as Benzalkonium chloride Avoid contact with the Eyes  
  55 Benzylhemiformal 0,15%   Only for products to removed by rinsing
  56 3-lodo-2- propynylbutylcarbamate 0.05%   1. Not to be use for oral hygiene and lip care products

2. If the concentration in pro- ducts intended to remain on the skin exceeds 0.02% add the phrase: contains iodine

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