Search This Blog

Wednesday, 25 April 2012

IFRA Compliance - a summary

IFRA Standards
International FRagrance Association

I’m always being asked, by people starting out in the make-your-own-perfume business what these are and how they apply to fragrances. Most people not in the industry seem to find the IFRA website a bit difficult to navigate too, so I thought I’d make up a summary list for quick reference. 



This summary is based on the 46th Amendment to the standards - notice that the 48th is now in force.  I'll remove this warning when it has been updated to include all those changes.

Disclaimer: This isn’t a substitute for looking up the details, it does not include everything (yet - though I’m nearly there) and I don’t accept liability for any errors or omissions (!) but you might find it helpful as a way of avoiding some of the more common pitfalls.

In each case I’m quoting the IFRA limit for Category 4 (which covers fine fragrance and anything in an alcohol base, sprayed on the skin for scent except products intended for freshly shaved skin where some of the limits are lower) or for ‘Leave-on’ products where applicable. All the percentages quoted are on a weight for weight basis and apply to the finished product.

I’ve tried to summarise the main things you are likely to come across from all the ProhibitedSpecification~ and Restricted (QRA and non-QRA) Standards, with the objective to make this list cover everything in due course.  See below for some new and changed standards that came into effect in June 2013.

Acetyl isovaleryl (5-Methyl-2,3-hexanedione) Prohibited
Alantroot oil (aka elecampane oil) Prohibited
Allyl heptine carbonate Prohibited
Allyl isothiocyanate Prohibited
Amyl cinnamic aldehyde 10.7%
Amylcyclopentenone Prohibited
Anisylidene acetone (4-(p-methoxyphenyl)-3-butene-2-one) Prohibited
cis-and trans-Asarone ((E)-and(Z)-2,4,5-Trimethoxypropen-1-yl benzene)~ * Prohibited
Benzene Prohibited
Benzaldehyde 0.27%
Benzyl alcohol 2.7%
Benzyl benzoate 26.7%
Benzyl cinnamate 2.1%
Benzyl salicylate 8.0%
Boldo Oil Prohibited
α-Butylcinnamaldehyde 0.45%
Cade Oil (crude) and Birch Tar (crude) Prohibited
Cade Oil (rectified)~ and Birch Tar (rectified)~ PAHs <1ppb 
Celeriax (3-Propylidenephthalide) 0.01%
Chenopodium oil Prohibited
Cinamic alcohol 0.4%
Cinnamaldehyde 0.05%
Citral* 0.6%
Citronellol* 13.3%
Citrus oils (expressed) 6%
Costus root oil, absolute and concrete Prohibited
Coumarin 1.6%
Cumin oil 0.4%
Cyclamen alcohol (up to 1.5% permitted as an impurity in ~Cyclamen aldehyde) Prohibited
Cyclamen propanal (p-tert-Butyldihydrocinnamaldehyde; Bourgeonal) 0.5%
Dimethyl anthranilate (Methyl N-methylanthranilate) 0.1%
Estragole* 0.2%
Eugenol* 0.5%
Farnesol* 1.2%
Fig leaf absolute Prohibited
Galbanum ketone (various trade names; 1-(5,5-Dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one) 1.13%
Geraniol* 5.3%
Geranyl acetate 6%
Grapefruit oil (expressed) 4%
Helional 5.3%
Hydratropic Aldehyde (2-Phenylpropionaldehyde) 0.17
Hydroxycitronellal 1%
Hyacinth absolute 0.3%
Hyacinth butanal (3-Phenylbutanal, Trifernal) 2.7%
Iso E Super 21.4%
Isoeugenol 0.2%
Ivy carbaldehyde (Dimethylcyclohex-3-ene-1-carbaldehyde (mixed isomers)) 2.7%
Jasmine Absolute 0.7%
Jasmine Sambac Absolute 4%
Leaf aldehyde (trans-2-Hexenal) 0.002%
Lemon (expressed) 2%
Lime (expressed) 0.7%
Linalool~ (Peroxide content less than 20 millimoles per litre)*
Lilial (p-tert-Butyl-α-methylhydrocinnamic aldehyde; BMHCA) 1.9%
Limonene (d, l and dl) (1-methyl-4-prop-1-en-2-ylcyclohexene) ~ (Peroxide content less than 20 millimoles per litre)*
Lyral (3and4-(4-Hydroxy-4-methylpentyl)-3-cyclohexene-1-carboxaldehyde (HMPCC)) 0.2%
Majantol (lily propanol; 2,2-Dimethyl-3-(3-tolyl)propan-1-ol) 4.5%
Melissa officinalis 0.63%
Methyl β-naphthyl ketone (Oranger Crystals) 0.2%
Methyl eugenol* 0.02% (‘Fine Fragrance’) or 0.008% (‘Eau de Toilette’)
Methyl heptadienone (6-Methyl-3,5-heptadien-2-one) 0.002 %
Methyl heptine carbonate 0.01 % (but total 0.002% if used with MOC)
Methyl Ionone (mixed isomers) 31.7%
Methyl octine carbonate 0.002%
3-Methyl-2-(pentyloxy)cyclopent-2-en-1-one 0.5%
Moskene Prohibited
Musk ambrette Prohibited
Musk indane (5-Acetyl-1,1,2,3,3,6-hexamethyl indan; AHMI; phantolid, fixolide) 2%
Musk Ketone 1-(4-tert-butyl-2,6-dimethyl-3,5-dinitrophenyl)ethanone ~ (Musk Xylene content less than 0.1% )
Musk tibetene Prohibited
Musk Xylene Prohibited
Nitrobenzene Prohibited
Oakmoss Absolute 0.1%
1-Octen-3-yl acetate 0.3%
Opoponax 0.4%
Patchouli ethanone (1-(1,2,3,4,5,6,7,8 Octahydro-2,3,8,8-tetramethyl-2-naphthalenyl) ethanone; OTNE) 21.4%
Peru balsam (crude) Prohibited
Phenylacetaldehyde 0.3 %
Quinoline Prohibited
Rose Ketones 0.02%
Santolina oil Prohibited
Safranal (2,6,6-Trimethylcyclohexa-1,3-dienyl methanal) 0.005%
Safrole, Isosafrole, Dihydrosafrole~ Prohibited (EOs containing these permitted if total below 0.01%)
Savin oil from Juniperus sabina Prohibited
Silvial / Suzaral / Rhodial (p-Isobutyl--methyl hydrocinnamaldehyde) 1.04% 
Styrax (from Liquidambar styraciflua macrophyla or Liquidambar orientalis only) 0.6%
Styrax (all other species) Prohibited
Tacrolimus (1-(2,4,4,5,5-Pentamethyl-1-cyclopenten-1-yl)ethan-1-one) 0.45%
Tea Leaf Absolute 0.2%
Tree Moss 0.1%
Toluene Prohibited
Trivertal (aka ivy carbaldehyde; Dimethylcyclohex-3-ene-1-carbaldehyde) 2.7%
Ultravanil (vanilla cresol; 2-Ethoxy-4-methylphenol) 0.1%
Versalide (Acetyl ethyl tetramethyl tetralin; Musk 36A) Prohibited
Verbena absolute (verbena oil is Prohibited) 0.2%
Vetiveryl acetate~ 1.04%
Ylang ylang extracts 0.8%

* - the main sources of these chemicals is in natural materials and you need to work out how much is in all the oils that contain them and keep the total in your product below the levels quoted here. These are some of the most complex standards to ensure compliance with.

~ = there is a Specification Standard for this material - check details via the Good Scents link for that material or directly on the IFRA Standards site.

NB The limits for Oakmoss and Tree Moss are cumulative (so the combination of both must be below 0.1%)

Explanation of IFRA Categories: When reading the standards maximum concentrations are given for each of the following 11 categories, but finding what goes in what category on the IFRA site is a bit like a treasure hunt, only not so much fun.

So for those who may be interested in something other than straightforward spray on fragrance, here is a full list of what goes where:


Finished product types
Category
Children's Toys // Lip products of all types (solid and liquid lipsticks, balms, clear or colored, etc…)
Class 1
Deodorant and Antiperspirant products of all types including any product with intended or reasonably foreseeable use on the axillae or labelled as such (spray, stick, roll-on, under-arm, deo-cologne and body spray, etc...) // Fragranced Bracelets // Nose pore strips
Class 2
Hydroalcoholic products applied to recently shaved skin (EdT range), includes After Shave
Class 3.A
Hydroalcoholic products applied to recently shaved skin (fine fragrance range), includes After Shave
Class 3.B
Eye Products of all types (eye shadow, mascara, eyeliner, eye make-up, etc…) including eye care // Men’s Facial Creams, Balms // Baby Lotion, cream and oil, Body paint for children
Class 3.C
Tampons
Class 3.D
Hydroalcoholic products applied to unshaved skin (EdT range) (includes aqueous based, alcoholic based and hydroalcoholic) like Cologne, Eau de Cologne, Eau de Parfum or Parfum // Ingredients of Perfume Kits // Scent Strips for hydroalcoholic products // Foil packs, Scent pads
Class 4.A
Hydroalcoholic products applied to unshaved skin (Fine Fragrance range) (includes aqueous based, alcoholic based and hydroalcoholic) like Cologne, Eau de Cologne, Eau de Parfum or Parfum
Class 4.B
Hair Styling Aids Sprays of all types (pumps, aerosol sprays, etc…) // Hair deodorant // Body Creams, Oils, Lotions of all types (except baby creams, lotions, oils) // Bodysprays (including Body Mist) with no intended or reasonably foreseeable use on the axillae // Body paint for adults // Fragrance Compounds for Cosmetic Kits // Foot Care Products
Class 4.C
Fragrancing Creams // Solid perfumes
Class 4.D
Wipes or Refreshing Tissues for Face, Neck, Hands, Body // Women's Facial Creams/Facial Make-up // Facial Masks // Hand Cream, Hand sanitizers // Baby Powder and Talc // Dry shampoo or waterless shampoo // Hair permanent and other hair chemical treatment (e.g. relaxers) but not hair dyes
Class 5
Mouthwash including Breath sprays, Toothpaste
Class 6
Intimate Wipes, Baby Wipes
Class 7.A
Insect Repellent intended to be applied on the skin
Class 7.B
Make-up Removers of all types (not including face cleansers) // Hair Styling Aids Non-Spray of all types (mousse, gels, leave-on conditioners, etc…) // Nail Care // All Powders & Talcs (except Baby Powder and Talc)
Class 8.A
Hair Dyes
Class 8.B
Liquid Soap, Bar Soap (toilet soap) // all Depilatories (including waxes for mechanical hair removal) // Conditioner (rinse-off), Shampoos of all types (including baby shampoos) // Face Cleansers of all types (washes, gels, scrubs, etc…) // Shaving Creams of all types (stick, gels, foams, etc…) // Body Washes of all types (including baby washes) and Shower Gels of all types // Bath Gels, Foams, Mousses, Salts, Oils and other products added to bathwater
Class 9.A
Feminine hygiene - pads/Liners, Toilet Paper, Wheat bags
Class 9.B
Other Aerosols (including air freshener sprays and air freshener pump sprays, but not deodorant/antiperspirants, hair styling aids spray, and animal sprays) // Facial Tissues, Napkins, Paper Towels  
Class 9.C
Hand wash/Machine Wash Laundry Detergents of all types (liquids, powders, tablets, etc…) including Laundry bleach and concentrates. Hand Dishwashing Detergent including concentrates // Other Household Cleaning Products (fabric cleaners, soft surface cleaners, carpet cleaners, etc…), Dry Cleaning Kits // Fabric Softeners of all types including softener sheets // Hard Surface Cleaners of all types (bathroom and kitchen cleansers, furniture polish, etc...) // Shampoos for pets // Scented gloves, socks, tights with moisturizers
Class 10.A
Diapers; Toilet Seat Wipes
Class 10.B
All non-skin contact or incidental skin contact: Air Fresheners and fragrancing of all types (concentrated aerosol with metered doses (range 0.05-0.5mL/spray), plug-ins, solid substrate, membrane delivery, electrical) // Toilet blocks // Joss Sticks, Incense // Cell phone cases // Insecticides (mosquito coil, paper, electrical, for clothing, etc...) excluding aerosols // Air delivery systems // Liquid refills for air fresheners (cartridge systems) // Scent delivery system using a dry air technology that releases a fragrance without sprays, aerosols or heated oils (technology of nebulization) // Air freshening crystals // Plastic articles (excluding toys) // Candles // Fuels // Paints // Floor wax // Fragranced lamp ring // Machine only Laundry Detergents (e.g. liquitabs) // Machine Dishwash Detergents and Deodorizers. Deodorizers/Maskers not intended for skin contact (e.g. fabric drying machine deodorizers, carpet powders) // "scratch and sniff" (sampling technology) // Pot pourri, fragrancing sachets, liquid refills for air fresheners (non-cartridge systems) // Reed diffusers // Shoe polishes // Cat Litter; Animal Sprays (all types) // Treatment products for textiles (e.g. starch sprays, fabric treated with fragrances after wash, deodorizers for textiles or fabrics), Odored distilled water
Class 11

If you want to understand the scientific methods used to determine the limits you can look at this document from RIFM which outlines the basis for Quantitative Risk Assessment as well as showing how it has been used in some specific cases.  It’s quite heavy going though . . .


Update Concerning 47th Amendment to the Code of Practice


The 47th Amendment brought in quite a few changes, which are summarised here pending integrating fully into the main section above, This information is taken from the notification letter implementing the standards, with additional information ferreted out by me to make it more useful:



There are six new restriction standards covering these materials:


CAS 
Name 
Status 
122-03-2 
Cuminaldehyde (0.5%)
NEW RESTRICTED 
(DERMAL SENSITIZATION QRA) 
103-95-7 
Cyclamen aldehyde (2.67%)
106-02-5 
Cyclopentadecanolide (2.5%)
4748-78-1 
p-Ethylbenzaldehyde (0.5%)
123-11-5 
p-Methoxybenzaldehyde (1.61%)
529-20-4 620-23-5 
104-87-0 
1334-78-7 
o,m,p-Tolualdehydes and their mixtures (0.5%)
I've added the maximum permitted in Category 4 products (which includes alcohol based perfumes but not aftershaves) to the table for reference.


Revised standards:

CAS 
Name 
Status 
119-84-6 
Dihydrocoumarin 
REVISED RESTRICTED (DERMAL SENSITIZATION QRA) 
8021-36-1 
9000-78-6 
93384-32-8 
Opoponax 
116-26-7 
2,6,6-Trimethylcyclohex-1,3-dienyl methanol (Safranal) 
8046-19-3 8024-01-9 94891-27-7 94891-28-8 
Styrax 
These implement a 0.6% maximum for both Opoponax and Styrax in all categories, 0.45% for Category 4 for Dihydrocoumarin and 0.005% in Category 4 for Safranal.


New Standard restricting the use of Furfural (CAS 98-01-1) 
This one is in a non-standard format and limits the use in all skin contact applications to 10 parts per million, non skin contact to 500 parts per million (equivalent to 0.001% and 0.05% respectively).

New Standard prohibiting the use of 2,4-Dienals (group Standard) 
764-40-9 
142-83-6 
80466-34-8 
5910-85-0 
30361-28-5 
6750-03-4 
2363-88-4 
13162-46-4 
21662-16-8 
25152-84-5 
30361-29-6 
4313-03-5 
plus any other materials that fall into this group - this standard replaces several individual standards for 2,4-hexadienal, 2,4-heptadienal, 2,4-octadienal, 2,4-nonadienal, 2,4-decadienal, and 2,4-undecadienal



Eleven revised Standards taking the contributions of Schiff Bases into account 
In essence this means that if a Schiff's Base composed of a restricted material is used you need to consider the amount of the restricted material in the Base as contributing to the total of the restricted material. alpha-Amyl cinnamic aldehyde, p-tert-Butyl-alpha-methylhydrocinnamic aldehyde (BMHCA), Benzaldehyde, Citral, Cinnamic aldehyde, Dimethylcyclohex-3-ene-1-carbaldehyde (Triplal), alpha-Hexyl cinnamic aldehyde, Hydroxycitronellal, 3 and 4-(4-Hydroxy-4-methylpentyl)-3-cyclohexene-1-carboxaldehyde (HMPCC or Lyral), 4-Methoxy-α-methylbenzenepropanal (Canthoxal or Fennaldehyde) and α-Methyl-1,3-benzodioxole-5-propionaldehyde (MMDHCA or Helional) are modified respectively (for more details see the table below).
  
One Standard, based on the dermal sensitization QRA, with a corrected maximum use level 
p-Mentha-1,8-dien-7-al (Perilla aldehyde, CAS 2111-75-3) was incorrect. The maximum use level for Category 7 should read 0.05% instead of 0.1% and the Standard has been corrected.




Here is some more information on the new ruling on Schiff's Bases made with restricted aldehydes, showing how much aldehyde you are to assume is present in each:


Aldehyde 
CAS (Aldehyde) 
Schiff base 
CAS 
(Schiff Base) 
Level of restricted aldehyde in the Schiff base (%) 
α-Amylcinnamaldehyde 
122-40-7 
α-Amylcinnamaldehyde-methyl anthranilate (or Jasmea, Seringone) 
68527-78-6 
60.3 
Benzaldehyde 
100-52-7 
Benzaldehyde methyl anthranilate (or Amandolene) 
39129-16-3 
44.4 
p-t-Butyl-α-methylhydrocinnamic aldehyde (Lysmeral) 
80-54-6 
Lysmeral-methyl anthranilate (or Verdantiol) 
91-51-0 
60.6 
Cinnamic aldehyde 
104-55-2 
Cinnamic aldehyde methyl anthranilate 
94386-48-8 
49.8 
Citral 
5392-40-5 
Citral-methyl anthranilate 
67801-47-2 
53.3 
2,4-Dimethylcyclohex-3-ene-1-carbaldehyde (Triplal) 
68039-49-6 
Triplal-methyl anthranilate (or Vertosine, Ligantraal, Agrumea) 
68738-99-8 
50.9 
α-Hexylcinnamaldehyde 
101-86-0 
α-Hexylcinnamic aldehyde methyl anthranilate (or Jasmea H) 
67924-13-4 
61.8 
Hydroxycitronellal 
107-75-5 
Hydroxycitronellal-Indole (or Indolene 50%) 
68527-79-7 
44.3 
Hydroxycitronellal 
107-75-5 
Hydroxycitronellal methyl anthranilate (or Aurantiol, Aurantium, Aurantoin) 
89-43-0 
56.4 
3 and 4-(4-Hydroxy-4-methylpentyl)-3-cyclohexene-1-carboxaldehyde (Lyral) 
31906-04-4 
51414-25-6 
Lyral-methyl anthranilate (or Lyrantion) 
67634-12-2 
61.3 
4-Methoxy-α-methylbenzeneproponal (Canthoxal, Fennaldehyde) 
5462-06-6 
Canthoxal-methyl anthranilate (or Canthalide, Anthranolene) 
111753-62-9 
57.3 
α-Methyl-1,3-benzodioxole-5-propionaldehyde (Helional, MMDHCA) 
1205-17-0 
Helional-methyl anthranilate (or Helioforte) 
111753-60-7 
59.1 


Most of this material first appeared, and is still maintained by me, on Basenotes