Beruflich Dokumente
Kultur Dokumente
CLINICAL TOXICOLOGISTS
(EAPCCT)
&
THE EUROPEAN COSMETICS TOILETRY AND
PERFUMERY
ASSOCIATION
(COLIPA)
COSMETIC
FRAMEFORMULATIONS
January 2000
2
2000/020 - MC
Page 1 of 5
EAPCCT / COLIPA
COSMETIC FRAME FORMULATIONS FOR
EU POISON CENTRES
- PREAMBLE
The EL Cosmetcs Directive specifies that Member States may require the provisicr of safety
information to the competent authority (in the majority of cases : Poison Centres) fcr products marketed
in the EJ. The puraose of this is to enable the correct rnedica treatment to be given promptly in the event
of an accident, such as a chid consuming a cosmetic product.
The exact wording given under Article 7 (3) is :
"Furthe-nore, a Member State may, for purposes of prompt and appropriate medica :reatment in the event of
difficulties, recuire that appropriate and adequate informscon on substances used in cosmetic products be made
available to the competent authory, which shall ensure that tre information is used only for the purposes of such
reatment".
. Both industry and the European Association of Poison Centres and Clinical Toxicobgists (EAFCCT)
were keen to introduce a simple system that is workable and avods the need to deal with unnecessary
cetailed paperwork. The concept of Frame formulations is based on a system developed jointly by the
UK Cosmetic, Toiletry and Perf-imery Trade Association (CTPA) with the National Poisons
lnforma:on Service (London), which has been ir use for many years.
The Frame Formulations detail the type of ingredients and their maximum concentration for most
cosmetic products on the European market. If a product "fits" the Frame Formulation, then only basic
nformation needs to be provided to the competent atthorities at national level, a st of whicn was
published in the Official journal of the European Communities (N C36, 10.C2.99).
It is planned to update the Frame Formulations on a regular basis - more or less once every two years
depending on the product type. Therefore a loose leaf system s foreseen where each Frame Formulation
will be identified by its number and the edition date - e.g. 2.12-2000 which means that it is Frame
Formulation 2.12 pupished in the year 2000.
More information should be given to Poison Centres upon request. These additions details will be
available from the emergency contact mentioned on the declaration form. This person should have
access to the qualitative and quantitatve composition of the product.
The majcrity of cosmetic products represent a relatively low risk on ingestion. The Frame
Formulations system enables rapid identification of a cosmetic product which is unlikely to result in
serious effects to health, when ingested or used inapprorriately.
Howeve under the Frame Formulations system some cosmetic products need to be declared in detail
or require additional information to be provided.
3
CONTENTS
PREAMBLE
QUICK REFERENCE FLOWCHART
DECLARATION FORM 1
DECLARATION FORM 2
DECLARATION FORM 3
UPDATE FORM
4
HAIR LOTION ............................................................................................................................................14
5
BATH OIL (INCLUDING BATH BEADS) ................................................................................................24
6
Frame Formulation Number: 9.2 - 2000 ............................................................................................ 33
SUN TAN OIL .............................................................................................................................................33
7
Frame Formulation Number: 12.2 - 2000 ........................................................................................ 43
BABY CREAM ............................................................................................................................................43
FRAME FORMULATIONS
Maximum
levels (% w/w)
95
25
25
25
20
20
12
10
10
10
5
5
3
2
1
to
100
8
Ingredients.
Silicones (e.g. z/clomethicone)
Oils and waxes e.g. mineral oils, lanolin)
Emollients, humectants (e.g. glycerin, propylene glycol)
Viscosity controling agents (e.g. carbomer, cellulose-ethers)
Additional ingredients (e.g. vitamins, antioxidants, plant extracts)
UV filters
Emulsifying agents, surfactants (e.g. PEG stearate, ceteareth)
Ethanol (alcohc . alcohol denat.)
Preservatives, a~:imicrobials
Parfum
Cosmetic colora~:s (e.g. iron oxide and pearl scent agents)
Aqua
Maximum
levels (% w/w)
20
20
15
12
10
10
5
3
2
1
1
to 100
Maximum
levels (% w/w)
50
30
15
10
10
5
2
2
1
1
to
100
Maximum
levels (% w/w)
90
80
50
30
10
5
1.5
0.1
Maximum
levels (% w/w)
10
10
10
9
Humectants (e.g. glycerin)
Parfum
Additional ingredients (e.g. antioxidants, cosmetic colorants)
Oils (mineral and/or vegetable) and s licones
5
5
1
to 100
Maximum
levels (% w/w)
50
25
20
10
8
5
5
3
2
1
1
to
100
Maximum
levels (% w/w)
40
30
20
10
5
5
2
1
to
100
Maximum
levels (% w/w)
70
25
10
5
5
4
3
2
2
1,5
1
1
to
100
10
FRAME FORMULATION NUMBER: 1.9 - 2000
FACIAL WASH
Ingredients.
Anionic surfactants e.g. sodium laureth sulfate, disodium laureth sufosuccinate ;
Emollients (e.g. glycerin)
Non-ionic / amphoieric surfactants (e.g. cocamide MIPA, ceteth-20, ethoxylerad
fatty alccnols)
Viscosity controlling agents (e.g. carbomer)
Additional ingredient (e.g. peartescent agents such as g/ycol distearate)
Emulsifying agents e.g. cetyl alcohol)
preservatives, antimicrcbials
Parfum
Cosmetic colorants
Chelating agents
Aqua
Maximum
levels (% w/w)
55
20
20
6
5
5
2
1
1
0.5
to 100
Maximum
levels (% w/w)
50
10
0.1
to 100
Maximum
levels (% w/w)
40
15
6
5
5
5
2
1
to 100
Maximum
levels (% w/w)
90
60
40
30
25
11
Ethanol (alcohol, alcohol denat.)
Additional ingredients (e.g. plant extracts, UV filters, antioxidants)
Emollients (e.g. isopropyl myristate)
Preservatives, antimicrobials
Parfum
Cosmetic colorants
Chelating agents
Aqua
20
5
5
2
1
1
0.5
to
100
Maximum
levels (% w/w)
50
25
25
10
10
2
1
1
to
100
Maximum
levels (% w/w)
90
25
5
Maximum
levels (% w/w)
40
20
10
6
3.5
2
1
0.5
to
100
12
ANTISEPTIC FOAMING GEL / FEMININE CLEANSING GEL
Ingredients.
Anionic surfactants (e.g. sodium lauroyl sarcosinate, disodium laureth
sulfosuccinate)
Non-ionic / amphoteric surfactants (e.g. betaine derivatives, glucose derivatives)
Emollients (e.g. glycerin)
Foam boosting agents (e.g. cocamide MIPA)
Additional ingredients (e.g. pearlescent agents, plant extracts)
Inorganic salts (e.g. sodium chloride)
Viscosity controlling agents (e.g. hydroxypropyl methylellulose)
Preservatives, antimicrobials
Parfum
Cosmetic colorants
Chelating agents
Aqua
Maximum
levels (% w/w)
20
15
10
5
5
3
3
2
1
1
0.5
to
100
Maximum
levels (% w/w)
30
20
15
10
5
each up to
5
each up to
5
1
0.5
to
100
mixed
sodium/potassium
stearates
and
Maximum
levels (% w/w)
70
30
10
1
Maximum
13
Anionic surfactants (e.g. sodium laureth sulfate)
Non-ionic surfactants (e.g. sodium dodecylbenzenesulfonate )
Amphoteric surfactants (e.g. betaine derivatives)
Viscosity controlling agents (e.g. fatty alcohols, stearyl alcohol)
Oils, waxes (e.g. mineral oil)
Silicones (e.g. cyclomethicone)
Cationic surfaciants > Ci2 (e.g. distearyldimonium chloride)
Cationic polymers (e.g. polyquaternium-11)
Humectants, emollients (e.g. glycerin)
Additional ingredients (e.g. UV filters, pearlescent agents)
Preservatives, antimicrobials
Cosmetic colorants
Chelating agents
Pnrfum
Aqua
levels (% w/w)
20
20
20
10
10
10
5
5
5
5
1
1
0.5
0.5
to
100
Maximum
levels (% w/w)
20
15
10
10
10
5
5
5
11
5
3
1
1
1
to
100
Maximum
levels (% w/w)
99
10
6
5
Maximum
levels (% w/w)
14
Oils and waxes (mineral and vegetable) (e.g. petrolatum, glyceryl stearate)
Hair conditioning agents (e.g. proteins and derivatives, cellulose
derivatives,cationic copolymers)
Silicones (e.g. dimethicone)
Emulsifying agents, surfactants (e.g. ethoxylated fatty acids)
Humectants (e.g. propylene glycol, glycerin)
Resins, polymers (e.g PVPA/A copolymer, acrylates copolymer)
Additional ingredients (e.g. UV filters, vitamins)
Parfum
Preservatives, antimicrobials
Aqua
60
20
20
15
10
5
2
1
1
to
100
Maximum
levels (% w/w)
99
3
3
2
1
1
Maximum
levels (% w/w)
60
20
10
3
2
2
2
1
0.5
to
100
Maximum
levels (% w/w)
80
10
10
10
5
2
15
Humectants (e.g. propylene glycol)
Ethoxylated glycols
Neutralising agents (e.g. aminomethyl propanol)
Additional ingredients (e.g. UV filters, vitamins)
Preservatives, antimicrobials
Cationic surfactants
Isopropyl esters of fatty acids
Hair eyeing agents, cosmetic colorants
Aqua
2
2
2
2
2
1
1
1
to
100
Maximum
levels (% w/w)
50
25
20
10
5
5
2
2
1.5
1
1
to
100
Maximum
levels (% w/w)
30
30
10
10
5
5
5
2
2
1
1
0.2
to
100
16
Ingredients.
Elhanol and/or isopropanol (alcohol, alcohol denat., isopropyl alcohol)
Propollants (e.g. dimethyl ether, hydrocarbons, hydrofluorocarbons)
Solvents (e.g. acetone, volatile silicones)
Resins, polymers (e.g. PVP/VA copolymer, VA/crotonates copolymer, butyl ester
of PVM/MA copolymer)
Neutralising agent (e.g. aminomethyl propanol) Alkoxylated glucose derivatives
Additional ingredients (e.g. UV filters, vitamins)
Plasticisers (e.g. lanolin derivatives, silicone oil)
Preservatives, antimicrobials
Parfum
Aqua
Maximum
levels (% w/w)
95
90
25
8.5
2
2
1
1
to
100
Maximum
levels (% w/w)
95
25
8.5
2
2
1
1
to
100
Maximum
levels (% w/w)
13
9.5*
10
7
5
6
3
3
2.5
2.5
1
1
0.5
0.3
to
100
17
Maximum
levels (% w/w)
9.5 *
10
3
7
5
3
3
2.5
2.5
2.5
1
1
0.5
0.3
to
100
Maximum
levels (% w/w)
12
5
7
5
3
3
2.5
2.5
1
1
0.5
0.3
to
100
PART1
Maximum
levels (% w/w)
18
Hydrogen peroxide
Non-ionic surfactants
Hair conditioning agents (e.g. proteins)
Stabilising agents
Aqua
pH value: 2.5-3.5
12
5
1
0.5
to 100
PART 2
Ammonium thiogiycolate
Alkalies (e.g. ammonium hydroxide or amines)
Ammonium salts (e.g. ammonium bicarbonate)
Anionic / non-ionic / amphoteric / cationic C12 surfactants (e.g. betaine
derivatives, dicetyldimonium chloride)
Parfum
Cosmetic colorants
Opacifying agents
Aqua
* before exothermic reaction with hydrogen peroxide
pH value: 7-9.5
Parts 1 and 2 are combined for use, the mixing of 1 and 2 is exothermic
pH value of combined ready-to-use mixture: 7 - 9.5
* after mixing : 11 % ammonium thiogiycolate calculated as thioglycolic acid
(professional use)
8 % ammonium thiogiycolate calculated as thioglycolic acid (general use)
20
5
5
3
1
1
0.5
to 100
Maximum
levels (% w/w)
PART 1
Thioglycolate ester (e.g. glyceryl thioglycolate)
Glycerin
99
50
PART 2
Reducing agents:
- ammonium thioglycolate
- cysteine HCI
Anionic / non-ionic / amphoteric surfactants (e.g. betaine derivatives)
Cationic surfactants > d2 (e.g. dicetyldimonium chloride)
Alkalies (e.g. ammonium hydroxide or amines)
Diammonium dithiodiglycolate
Silicones (e.g. amodimethicone)
Hair conditioning agents (e.g. proteins, polymers)
Opacifying agents
Paiium
Aqua
pH value of Part 2: 8-9.5
pH value of Parts 1 and 2 mixed ready-for-use: 6.5 - 9
5
10
10
5
5
4
3
2
1
1
to
100
Maximum
levels (% w/w)
8
19
Hydrogen peroxide
Viscosity controlling agents (e.g. carbomer)
Hair conditioning agents (e.g. silicone)
Parfum
Cosmetic colorants
Hydrogen peroxide stabilising agents (e.g. phenacetin, sodium siannate,
oxyquinoline sulfate )
Opacifying agents (e.g. styrene/PVP copolymer)
Preservatives, antimicrobials
Chelating agents
pH adjuster (e.g. citric acid)
Aqua
2-6
2
2
1
1
0.5
0.5
0.2
0.2
qs pH 2.5-3.5
to
100
Maximum
levels (% w/w)
80
30
15
15
5
4.5
2
2
1
to
100
Maximum
levels (% w/w)
CREAM BASE
Calcium hydroxide
Waxes and oils (e.g. mineral such as petrolatum)
Humectants, emollients (e.g. lanolin, cholesterol)
Anionic / non-ionic / amphoteric surfactants (e.g. betaine derivat^.es)
Emulsifying agents (e.g. fatty alcohols and their ethoxylates)
Hair conditioning agents (e.g. proteins, polymers)
Additional ingredients (e.g. plant extracts)
Parfum
Aqua
pH value: 11-13
10
80
30
10
10
5
5
1
to 100
ACTIVATOR
Guanidine carbonate
Polymers, resins, hair conditioning agents
Additional ingredients (e.g. humectants such as sorbitol)
Parfum
Cosmetic colorants
30
5
5
1
1
20
Aqua
pH value: 10- 13
Mixed with cream base at the time of use to generate an alkaline mix of up to
5 % alkali calculated as calcium hydroxide.
pH value of cream base and activator mixed prior to use: 11 -13.5
to 100
Maximum
levels (% w/w)
15
10
7
5
5
1
1
to
100
Maximum
levels (% w/w)
10
5
5
5
5
3
1
1
to
100
Maximum
levels (% w/w)
60
5
4
1
1
0.2
cs pH 3 - 9
to
100
10
21
Maximum
levels (% w/w)
50
11
10
10
10
5
5
5
5
3
2
1
1
qs pH 6 - 1 0
to
100
10
Maximum
levels (% w/w)
PART - I
Anionic / non-ionic / amphoteric surfactants (e.g. ammonium laureth sulfate,
laureth-12)
Emulsifying agents (e.g. ethoxylated fatty alcohols)
Soaps (e.g. ammonium hydroxide/ethanolamine oleates)
Solvents (e.g. propy/ene glycol, benzyl alcohol, glycol ethers such as
butoxydiglycol)
Ethanol and/or isopropanol (alcohol, alcohol denat., isopropyl alcohol)
Hair dyeing agents
Alkaline agents (e.g. ammonium hydroxide*, ethanolamine)
Viscosity controlling agents (e.g. carbomer, fatty alcohols)
Cationic surfactants > C12 (e.g. dicetyldimonium chloride, PEG-2 oleamine)
Cationic polymers (e.g. polyquaternium-34)
Additional ingredients (e.g. hair conditioning agents, pearlescent agents)
Reducing agents (e.g. sodium metabisulfite)
Parfum
Chelating agents (e.g. EDTA)
Aqua
pH value: 8-11.5
* maximum concentration of ammonium hydroxide permitted is 6 %
60
30
30
20
16
12
10
10
5
5
5
3
2
-1
to
100
22
Maximum
levels (% w/w)
PART II
Hydrogen peroxide
Surfactants, emulsifying agents (e.g. ethoxylated fatty alcohols)
Humectants (e.g. glycerin)
Chelating agents
Hydrogen peroxide stabilising agents (e.g. sodium stannate, phenacetin)
pH adjuster (e.g. phosphoric acid)
Aqua
pH value of Part I and Part II mixed prior to use: 8 -11.5
12
10
5
0.5
0.5
qs pH 2-3
to
100
Maximum
levels (% w/w)
35
20
10
10
3
1
0.6 calculated
as lead
to
100
Maximum
levels (% w/w)
to
13
100
to
20
100
Maximum
levels (% w/w)
70
50
23
Humectants (e.g. sodium lauryi sulfate)
pH adjusters (e.g. sodium metasilicate)
Ammonium hydroxide liberators (e.g. ammonium chloride, diammonium
phosphate)
Viscosity controlling agents (e.g. guar gum)
Additional ingredients (e.g. cosmetic colorants, chelating agents)
" pH adjuster qs 10 < pH < 11 at 1 % powder in water
HAIR BLEACHING SOLUTION
NB: solutions A and B are mixed immediately prior to
use Solution A
Hydrogen peroxide
Surfactants, emulsifying agents (e.g. ethoxylated fatty alcohols)
Humectants (e.g. glycerin)
Chelating agents (e.g. tetrasodium pyrophosphate)
Hydrogen peroxide stabilising agents (e.g. sodium stannate)
pH adjusters (e.g. phosphoric acid)
Aqua
15
15
12
5
5
12
10
5
0.5
0.5
qs pH 2-3
to
100
Ingredients.
Solution B
Anicnic / non-ionic surfactants (e.g. ammonium laureth sulfate, laureth-12)
Emulsifying agents (e.g. fatty alcohols)
Soaps (e.g. ammonium oleate)
Ethanoi and/or isopropanol (alcohol, alcohol denat., isopropyl alcohol)
Solvents (e.g. propylene glycol)
Ammonium hydroxide
Parium
Additional ingredients (e.g. cosmetic colorants, chelating agents,
conditioning agents)
Aqua
pH value solution B: 8 - 10
pH value of the different mixtures: 9.5 -11.5
60
30
30
20
20
3.5
1
5
hair
to
100
Maximum
levels (% w/w)
50
40
20
10
10
6
6
5
3
3
24
Cosmetic colorants
Preservatives, antimicrobials
Cheiaung agents
Aqua
1
1
0,5
130
Maximum
levels (% w/w)
40
30
15
10
10
5
5
1
1
0.5
to 100
bicarbonate,
sodium
Maximum
levels (% w/w)
99
5
5
1
1
1
0.5
6
Maximum
levels (% w/w)
90
15
10
10
1.5
1
0.1
25
Maximum
levels (% w/w)
22
10
10
10
5
5
to
100
Maximum
levels (% w/w)
60
30
15
15
10
5
2
2
1
1
0.5
0.5
0.5
0.1
to
100
40
20
10
10
2
2
0.5
to
100
Maximum
levels (% w/w)
26
'Film forming agents (e.g. glyceryl polymethacrylate)
Silicones (e.g. dimethicone)
Viscosity controlling agents (e.g. hydroxyethylcellulose)
emulsifying agents, surfactants (e.g. sodium laureth sulfate)
Additional ingredients (e.g. vitamins, plant extracts)
Parfum
Cosmetic colorants
Preservatives, antimicrobials
Aqua
10
5
3
3
2
1
1
1
to 100
Maximum
levels (% w/w)
30
15
10
5
5
2
2
2
2
1
0.2
0.2
to
100
Maximum
levels (% w/w)
30
15
15
10
10
10
5
2
1
1
1
0.5
to 100
Maximum
levels (% w/w)
90
27
Humectants (e.g. glycerin)
Non-ionic surfactants (e.g. polysorbates)
Silicones (e.g. dimethicone)
Additional ingredients (e.g. vitamins, plant extracts, chelating agents)
Parfum
Titanium dioxide
Preservatives, antimicrobials
Antioxidants
Menthol
15
5
5
2
2
1
1
0,1
0.1
Maximum
levels (% w/w)
40
20
20
20
10
5
5
1
1
1
0.5
to
100
Maximum
levels (% w/w)
90
15
10
10
1
0.5
to
100
60
Maximum
levels (% w/w)
98
40
10
2
28
UV filters
Viscosity controlling agents (e.g. carbomer)
Cosmetic colorants
Additional ingredients (e.g. chelating agents)
Antioxidants
Aqua
For aerosol products: propellants (e.g. hydrocarbons)
2
2
1
1
0.1
to
100
60
Maximum
levels (% w/w)
95
10
10
10
10
5
5
4
3
0.1
Maximum
levels (% w/w)
95
95
25
15
10
5
4
3
1
to
100
Maximum
levels (% w/w)
65
65
29
waxes (e.g. petrolatum, isoparaffins)
Antiperspirant salts (e.g. aluminium salt or aluminium/zirconium complex)
Viscosity controlling agents (e.g. starch), emollients (e.g. glycerin),emulsifying
agents (e.g. steareths, PPG ethers)
Additional ingredients (e.g. plant extracts)
Deodorants (e.g. zinc ricinoleate)
Parfum
Preservatives, antimicrobials
A qua
25
25
5
5
3
1.5
to 100
Maximum
levels (% w/w)
75
65
25
5
5
3
1.5
to
100
Maximum
levels (% w/w)
80
80
70
30
25
15
15
15
5
5
3
1
to
100
30
Ingredients.
Ethanol (alcohol, alcohol denat.)
Humectants (e.g. propylene glycol, glycerin)
Silicones, volatile silicones (e.g. cyclomethicone, dimethicone), mineral oils and
waxes (e.g. petrolatum, isoparaffins)
Emollients, waxes (e.g. isopropyl myristate, cetyl alcohol, stearyl alcohol)
Soaps, emulsifying agents (e.g. sodium stearate)
Talc
Fillers (e.g. stearalkonium bentonite)
Additional ingredients (e.g. plant extracts, EDTA)
Deodorants (e.g. zinc ricinoleate)
Parfurn
Preservatives, antimicrobials
Aqua
Maximum
levels (% w/w)
80
80
70
30
15
15
15
5
5
3
1
to
100
Maximum
levels (% w/w)
80
30
15
8
5
4
3
1
to
100
Maximum
levels (% w/w)
95
15
8
5
4
3
1
to
100
Maximum
levels (% w/w)
31
Antiperspirant salts (e.g. aluminium or zirconium salts)
Humectants (e.g. propylene glycol)
Emollients (e.g. fatty alcohols, vegetable oil)
Emulsifying agents (e.g. ceteareth-30, PEG stearate)
Additional ingredients (e.g. plant extracts, EDTA)
Deodorants (e.g. zinc ricinoleate)
Paiium
Preservatives, antimicrobials
Aqua
30
25
10
10
5
5
3
0.5
to 100
Maximum
levels (% w/w)
99
20
10
5
5
5
2.5
2
2
2
1
to
100
Maximum
levels (% w/w)
40
40
20
20
10
5
5
5
5
2
2
1
to
100
Maximum
levels (% w/w)
32
Sorbitol
Abrasives (e.g. dicalcium phosphate dihydrate and/or alumina and/or calcium
carbonate and/or s/7/ca and silicates)
Glycerin
Insoluble metaphosphate (IMP)
Ethanol (alcohol, alcohol denat.)
Sodium pyrophosphate, potassium pyrophosphate
PEG, PPG
Oral care-protecting agents (e.g. strontium chloride)
Anionic surfactants (e.g. sodium lauryl sulfate)
Viscosity controlling agents (e.g. cellulose derivatives)
Additional ingredients (e.g. pH stabilisers such as sodium/potassium phosphate)
Flavour (mostly essential oils, e.g. mint)
Titnnium dioxide
Cosmetic colorants
Oral care-antiplaque (e.g. zinc citrate, bromochlorophene)
Oral care-sweetening agents (e.g. saccharin)
Esters of hydroxybenzoic acid
Calcium glycerophosphate
Fluoride compounds (calculated as Fluorine)
*
actual weight present will depend on M.Wt. of fluorine donor, e.g. 0.15%
fluorine = 1.14 % MFP (monofluorophosphate) or 0.333 % NaF (sodium fluoride)
70
55
40
35
30
15
10
10
6
5
5
3
2
1
1
0.5
0.4
0.15
0.15 *
Maximum
levels (% w/w)
25
22
5
3
3
3
0,5
0,5
0,5
0,2
0,15 *
to
100
Maximum
levels (% w/w)
80
80
7.5
5
3
33
Emulsifying agents, surfactants (e.g. ethoxylated fatty alcohols)
Preservatives, antimicrobials
Oral care-sweetening agents (e.g. sodium saccharin)
Aqua to
100
2
1
0.2
Maximum
levels (% w/w)
99
30
2
0.5
0.2
0.2
0.1
to
100
Maximum
levels (% w/w)
70
30
20
15
10
10
6
5
5
3
2
1
to
100
Maximum
levels (% w/w)
40
15
6
5
3
1
1
1
to 100
34
Maximum
levels (% w/w)
60
20
20
15
15
6
1
to
100
Maximum
levels (% w/w)
60
15
6
5
5
5
5
1
1
1
to
100
Maximum
levels (% w/w)
20
10
6
1
1
0.5
to
100
Maximum
levels (% w/w)
50
35
Emulsifying agents (e.g. glyceryl stearate, PEG stearate)
Humectants (e.g. glycerin, PEG)
Silicones (e.g. cyclomethicone)
Surfactants (e.g. sodium cocoyl isethionate, sodium laureth sulfate)
UV filters
Reflecting agents (e.g. titanium dioxide, zinc oxide)
Additional ingredients (e.g. plant extracts, vitamins,bisabolol)
Dihydroxyacetone
Viscosity controlling agents (e.g. carbomer)
Preservatives, antimicrobials, chelating agents
Parfum
Cosmetic colorants (including iron oxides)
Aqua
25
25
20
20
15
1C
5
6
5
2
1
1
to
100
Maximum
levels (% w/w)
60
15
10
10
6
6
3
1
1
0.5
0.5
to
100
Maximum
levels (% w/w)
30
30
30
30
25
20
20
5
5
5
1
1
to
100
36
FOUNDATION (ANHYDROUS)
Ingredients.
Oils (e.g. mineral, vegetable)
Silicones and volatile silicones (e.g. dimethicone)
Fillers (e.g. nylon, talc, kaolin, silica)
Waxes (e.g. cera alba, carnauba)
Cosmetic colorants, pigments
Viscosity controlling agents, emulsifying agents (e.g. sodium stearate, potassium
stearate)
Humectants (e.g. glycerin)
Emollients (e.g. lanolin)
UV filters
Additional ingredients (e.g. proteins, vitamins)
Preservatives, antimicrobials
Parfum
Antioxidants
Maximum
levels (% w/w)
70
40
30
20
20
20
10
10
5
5
1
1
0.1
Maximum
levels (% w/w)
20
20
20
20
10
6
3
3
2
to
100
Maximum
levels (% w/w)
70
5
2
2
2
1
0.1
to
100
Maximum
levels (% w/w)
37
Waxes, oils, fats (e.g. mineral oil, ricinus communis, cera alba, microcrystalline
wax)
Emollients (e.g. lanolin oil, isopropyl myristate)
Opacifying agents (e.g. calcium carbonate)
Cosmetic colorants, pigments
Fillers (e.g. talc)
Viscosity controlling agents (e.g. stearalkonium hectorite, propy/ene carbonate)
Emulsifying agents (e.g. PEG derivatives, PPG derivatives)
Preservatives, antimicrobials
Additional ingredients (e.g. plant extracts, vitamins, antioxidants)
UV filters
55
50
40
30
15
10
6
5.5
5
3
Maximum
levels (% w/w)
95
50
30
20
20
20
15
10
5
5
3
1.5
1.5
Maximum
levels (% w/w)
65
65
40
35
20
10
6
2
1
1
to
100
38
Ingredients.
Oils, fats and waxes (e.g. mineral and vegetable oils, lanolin, ricinus communis)
Film forming agents (e.g. stearalkonium hectorite, polybutene)
Emollients (e.g. glycerin, propylene glycol)
Cosmetic colorants, colour additives (e.g. pearlescent agents)
Sunscreen products contain reflecting agents (e.g. titanium dioxide, zinc oxide)
and UV filters
Viscosity controlling agents (e.g. carbomer, hydroxyethylcellulose)
Additional ingredients (e.g. vitamins, proteins)
Parfum
Antioxidants and preservatives, antimicrobials
Flavouring agents
Oral care-sweetening agents (e.g. saccharirn
Maximum
levels (% w/w)
90
80
50
30
30
10
5
2
1
1
0.02
Maximum
levels (% w/w)
90
50
30
20
10
5
5
1
0.5
Maximum
levels (% w/w)
95
10
5
1
Maximum
levels (% w/w)
90
25
25
10
10
10
5
1
39
Parfum
Aqua
1
to
100
Maximum
levels (% w/w)
80
20
10
5
1
1
to
100
70
50
5
1
1
Maximum
levels (% w/w)
70
50
20
10
10
5
5
2
1
1
1
to
100
70
70
35
35
25
15
5
1
1
0.1
40
Maximum
levels (% w/w)
70
50
50
30
20
60,
5
5
5
1
0.3
Maximum
levels (% w/w)
25
25
25
20
10
10
10
5
5
1
1
to
100
70
50
10
5
1
1
Maximum
levels (% w/w)
25
25
20
41
Silicones, volatile silicones (e.g. cyclomethiccne)
Humectants (e.g. propylene glycol, glycerin)
Viscosity controlling agents (e.g. magnesium silicate ,aluminum silicate, PEG
derivatives)
Film forming agents (e.g. ammonium acrylates copolymer,cellulose derivatives,
acetyl trihexyl citrate)
Ethanol (alcohol, alcohol denat.)
Fibres (e.g. cellulose, nylon fibres)
Isoparaffins
Emollients (e.g. isopropyl myristate)
Additional ingredients (e.g. vitamins, plant extracts)
Preservatives, antimicrobials
Parfum
Aqua
20
15
15
15
11
10
5
5
5
2.5
0.2
to
100
Maximum
levels (% w/w)
80
80
30
25
20
15
15
12
10
10
5
5
1
1
1
1
Maximum
levels (% w/w)
50
50
20
20
25
5
1
42
FRAME FORMULATION NUMBER: 11.1 - 2000
NAIL CONDITIONER (OIL BASED)
Ingredients.
Unsaturated fatty acids, proteins, vtamins
Cosmetic colorants
Antioxidants, preservatives, antimicrobials
Parfum
Vegetable oils (e.g. sesame oil)
For aerosol products: propellants i=.g. hydrocarbons)
Maximum
levels (% w/w)
10
1
0.2
0.1
to 100
90
Maximum
levels (% w/w)
80
30
25
5
Maximum
levels (% w/w)
90
90
50
15
15
10
5
5
2
Maximum
levels (% w/w)
30
15
15
10
5
2
5
43
Preservatives, antimicrobials
Cosmetic colorants
Parfum
Aqua
1.5
1
0.5
to
100
Maximum
levels (% w/w)
60
30
20
20
12
10
10
10
1.5
0.5
0.3
to
100
Maximum
levels (% w/w)
25
10
10
10
2
0.1
to
100
Maximum
levels (% w/w)
100
0.5
Maximum
levels (% w/w)
5
5
44
PEG-5 stearyl ammonium lactate)
Additional ingredients (e.g. plant extracts, bisabolol )
Parfum
Preservatives, antimicrobials
Aqua
10
1.5
1
to
100
Maximum
levels (% w/w)
20
5
5
1
0.5
0.5
0.5
to 100
Maximum
levels (% w/w)
99
50
30
20
20
10
10
10
5
1
Maximum
levels (% w/w)
15
15
15
8
5
1
qs pH 1112.7
to
100
45
Maximum
levels (% w/w)
15
15
4
0.5
qs pH 2-3
to
100
Maximum
levels (% w/w)
30
10
5
2
2
1
0.5
to
100
Maximum
levels (% w/w)
30
10
5
5
5
2
2
to
100
46
EAPCCT/COLIPA
FRAME FORMULATION SYSTEM FOR COSMETIC
PRODUCTS
UP DATE FORM
The EAPCCT/Colipa Frame Formulations booklet is intended to be regularly updated by
the Joint EAPCCT/Colipa Update Committee.
As a first step, all proposals for modifications of existing Frame Formulations or for addition
of new ones should be sent to the Colipa secretariat via National Associations.
Types of amendments that can be made:
modification of an exist ng Frame Formulation:
- increase/decrease of tie maximum concentration of a certain ingredient
- addition/deletion of an ingredient
acdition of a new Frame Formulation
Please follow these instructions:
1. Use one Update Forrr as attached for one Frame Formulation only (whether it is for the modification of
en existing Frame Formulation or for the proposal of an additional one);
2. Please fill in all the information requestec in a legible manner;
3. Explain the reason for your request; if need be, you may attach an additional sheet with explanations.
4. Please indicate the type of ingredient(s); please also provide one or more examples of ingredients for
each type, using their INCI names.
47
UFN: _______________
For internal use
Companv: ________________________________________________________
Address:________________________________________________________
Telephone:____________________ Fax: _______________________________
Type of ingredients
(piease add examples using INCI names)
Date: ______________
Maximum levels
(% w/w)
Signature: _______________________
ARTICLE 7.3 OF THE COSMETICS DIRECTIVE : DECLARATION OF THE COMPOSITION OF COSMETIC PRODUCTS
USING THE FRAME FORMULATIONS (FF) SYSTEM
QUICK REFERENCE FLOWCHART (Please also read the Preamble to the Frame Formulations booklet)
DOES A FRAME FORMULATION EXIST FOR YOUR PRODUCT ?
NO
YES
DOES YOUR PRODUCT COMPLY WITH THE FRAME FORMULATION ?
NO
YES
NO
USE DECLARATION FORM 1
YES
USE DECLARATION FORM 2
opacifiers
Substances which are added to transparent or translucent cosmetic products to render them more impervious to
visible light and nearby radiation
viscosity controlling agents
Substances which are added to cosmetic products to increase or decrease the viscosity of the finished product
binders
Substances which are added to solid cosmetic mixtures to provide cohesion
buffering agents
Substances which are added to cosmetic products to adjust or stabilize the pH thereof
50
emulsifying agents
Substances which are added to cosmetic products and which are surface-active agents that promote the formation of
intimate mixtures of immiscible liquids
denaturants
Substances which are mostly added to cosmetic products containing ethyl alcohol, in order to render124 them
unpalatable
hair dyes
Substances which are added to cosmetic products to colour hair
reducing agents
Substances added to cosmetic products which change the chemical nature of another substance by adding hydrogen
or removing oxygen
chelating agents
Substances which are added to cosmetic products to react and to form complexes with metal ions which could
affect stability and/or appearance of cosmetics
depilating agents
Substances which are added to cosmetic products to remove unwanted body hair
antiperspirant agents
Substances which are added to cosmetic formulation to reduce perspiration
biological additives
Substances derived from biological origin which are added to cosmetic products to achieve specific formulation
features
bleaching agents
Substances which are added to cosmetic products with the intention of lightening the shade of hair or skin
botanicals
Substances which are derived from plants, mostly by physical means, added to cosmetic products to achieve specific
formulation features
cosmetic colorants
Substances which are added to cosmetic products to colour the cosmetic product and/or to impart colour to the skin
and/or its appendages. All colours listed are substances of the positive list of colorants (Annex IV of the Cosmetic
products Directive)
humectants
Substances which are added to cosmetic products to hold and retain moisture
oxidising agents
Substances which are added to cosmetic products to change the chemical nature of another substance by adding
oxygen
preservatives
Substances which are added to cosmetic products for the primary purpose of inhibiting the development of
micro-organisms therein
propellants
Gaseous substances added to cosmetic products under pressure in pressure-resistant containers for expelling the
contents of the containers when the pressure is released
U.V. absorbers
Substances which are added to cosmetic products specifically intended to filter certain UV rays in order to protect the
skin or the products from certain harmful effects of these rays. In order to protect the skin from these effects, only the
use of substances listed in Annex VII of the Cosmetic products Directive is allowed
Last update 25 January 2001