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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