The Best Allergy and Asthma Articles of the Year Rescue Use of Beclomethasone and Albuterol in a Single Inhaler for Mild Asthma. Papi et al. NEJM 2007;356:2040-52. Background: Treatment guidelines recommend the regular use of inhaled corticosteroids for patients with mild persistent asthma. We investigated whether the symptom-driven use of a combination of beclomethasone dipropionate a
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Microsoft word - cnc standards_2_3__eng.docKEZ o.p.s. Poděbradova 909, 537 01 Chrudim E-mail: [email protected] URL: http://www.kez.cz CNC Standards
Certification of Natural and Organic Cosmetics
Version: 2, Revision: 3
In force from: 14 January 2014
KEZ o.p.s. (KEZ) is a public benefit corporation accredited as a certification body that
performs independent inspection and certification of producers, processors and
traders involved in the ecological agriculture system.
Due to the increasing consumer demand for cosmetic preparations containing natural
ingredients or organic products, and an absence in the Czech Republic of a
certification agency that would deal with these issues systemically, KEZ inspection
agency has decided to develop CNC – Standards for Certification of Cosmetic
Preparations (hereinafter referred to as the Standards), defining requirements on
cosmetic preparations that are not included in Council Regulation (EC) no. 834/2007
on organic production.
We have invited experts on cosmetic production and cosmetic care professionals to
collaborate on the development of the Standards and the assessment process.
The qualitative indicators for cosmetic preparations are ensured by traceability of the
components throughout their development, manufacture and distribution process in
relation to the environment. This ensures total product integrity down to the end
The purpose of the Standards is to provide consumers with true and verifiable
information about the content of organic and eco-friendly ingredients in certified
cosmetic preparations. The certification logo awarding process is in compliance with
the ethical principles of the independent certification agency KEZ o.p.s.
Any substance or mixture intended for contact with the outer parts of the human body
(skin, hair system, nails, lips, outer genitalia) or the teeth and mucous membranes of
the oral cavity, exclusively or mostly for the purpose of cleaning them, perfuming
them, changing their appearance, protecting them, keeping them in good condition,
or modification to bodily odours.
A chemical element and its compounds in their natural condition or obtained via a
production process, including all additives necessary for maintaining its stability and
all impurities produced during the process, excluding any solvents that can be
separated without affecting the substance stability or changing its composition.
A mixture or solution composed of two or more substances.
A natural person or a body corporate that manufactures a cosmetic preparation or
that has had a cosmetic preparation designed or manufactured and markets it under
its name or trademark.
Delivery of a cosmetic preparation for distribution, consumption or use on the
Community market as part of business operation, whether against a payment or free
An organic ingredient is a component of a cosmetic preparation for which KEZ o.p.s.
or another of the inspection agencies listed in the Journal of the European Union has
issued a certificate of organic origin in compliance with Council Regulation (EC) no.
Natural cosmetics are such cosmetic preparations that both comply with the
Standards parameters and contain exclusively environmentally friendly ingredients
enumerated in the positive list in Annex 1 to the Standards.
Ingredient of natural origin
An ingredient of natural origin is a substance or mixture of substances that are
naturally found in nature and have been obtained for the cosmetic preparation from
nature. Ingredients analogous to natural ones that have been obtained through
chemical synthesis are not considered of natural origin. Such ingredients may
subsequently be treated chemically exclusively using the methods listed in 3.3 below.
If an ingredient is composed of a substance(s) of natural origin and a synthetic
substance permissible hereunder, the certification applicant shall specify the
proportion of the natural and synthetic components in weight percentages. The
calculation formula for determining the content of the synthetic ingredient component
in the cosmetic preparation is shown in Annex 2 to the Standards. The certification
body has the right to verify the proportion, request the applicant to furnish
documentation based on which it performed the calculation, and verify the validity
and correctness of the documentation.
Water shall not be included among the natural component proportions. However, if it
is listed as Aqua among the Ingredients (INCI), it has to comply with the legislative
parameters for that appellation. The policy is that ingredients as per this paragraph
have to comply with the general requirements for ingredients permissible for final
CNC – CERTIFIED NATURAL COSMETICS
A cosmetic preparation that has complied with the Standards parameters, contains at
least 85% of components of natural origin, provided that KEZ o.p.s. certification
agency has issued a certificate for it and it contains exclusively substances listed
among the ingredients of Annex 1 to the Standards.
A cosmetic preparation that has complied with the Standards parameters and
contains at least 90% of components of natural origin while at least 20% of the
weight percentage of the natural components has to be organic.
1. GENERAL PRINCIPLES OF THE STANDARDS
The purpose of the CNC Standards is to set unambiguous and transparent rules for
both manufacturers and suppliers of cosmetic preparations that contain ingredients
originating from ecological agriculture or environmentally friendly ingredients.
The Standards apply to cosmetic preparations that are expected to comply with
Regulation (EC) no. 1223/2009 of the EP and of the Council on cosmetic products,
Commission Regulation (EU) No 655/2013 laying down common criteria for the
justification of claims used in relation to cosmetic products, as amended and Act no.
258/2000 Coll. on public health protection as amended. Failing the aforesaid
legislative requirements, a cosmetic preparation cannot be certified under the
In obtaining the ingredients, the manufacturer shall take care to make considerate
use of nature and conserve it in its natural forms, including protection of animal and
plant species and inorganic components. Use of genetically modified ingredients
(GMO) and ingredients that employ methods based on genetic engineering in any
stage of their development or production is prohibited. This requirement applies to all
the ingredients of a certified cosmetic preparation. CNC may only contain animal
ingredients listed in Annex 1. Use of ingredients obtained from dead, stunned or ill
animals or animals undergoing treatment or pharmacological nutritional and
the ingredients, the manufacturer takes care to minimize the destruction of and
Prior to certification (i.e., during inspection etc.), the cosmetic preparation
manufacturer shall provide documents that prove the compliance of the cosmetic
preparation with the legal requirements for sale within the single market of the
European Community (hereinafter, the Market) in compliance with the Directive.
If the cosmetic preparations conform to COSMOS Standards (available at
http://www.cosmos-standard.org/), they shall be deemed to conform with the CNC
Standards as well. The applicant shall prove the conformity of the cosmetic
preparations for which certification is requested with a valid proof (certificate) issued
under the COSMOS Standards. The cosmetic ingredients (chemical substances and
chemical mixtures) listed in annexes to COSMOS Standards in force (Annexes IV
and V) can be used in the formula for a cosmetic preparation under CNC Standards.
Cosmetic preparations are subject to constant research and development. The
Standards may be subject to amendments and modifications as a result of legislative
changes, environmental requirements and keeping the cosmetic preparations made
under the Standards reliable towards the consumers.
Holders of the right to use the CNC CERTIFIED NATURAL COSMETICS and CNC
Organic (cosmetic preparation manufacturers or distributors) shall be informed about
changes to the Standards, typically via electronic mail.
2. THE RULES
2.1. ORIGIN OF INGREDIENTS
Plant-based ingredients contained in CNC can be of two qualities:
a) They originate from ecological agriculture or from collection of herbs or fruits growing in the wild. Such ingredients are referred to as organic ingredients in the Standards. A certificate of ecological origin has been issued for such organic ingredients by an inspection agency (see list of inspection agencies in the Journal of the EU). Only such ingredients may be listed as organic ingredients on the CNC labels. b) They are of plant origin and such origin is reliably documented by the c) The calculation of the content percentage shall be made depending on the method of indicating the quantity of the final preparation in volume or weight percentage. Water contained in the product shall not be included in the basis for calculating the percentages. d) The product must not contain identical organic and conventional
2.2. OTHER INGREDIENTS
Ingredients of an origin other than plant-based may only be used in cosmetic
preparations under these Standards in case they are listed in Annex 1 to these
2.3. ANIMAL PROTECTION
CNC, their prototypes or development stages or basic ingredients (documented by a
statutory declaration) must not be tested on animals by the manufacturer, first
distributor or any other distributor after 1 January 2000. Neither may the aforesaid
parties commission such testing with other parties. Testing on animals does not
include testing on cultivated tissues or separate isolated somatic cells.
3. SUBSTANCES AND PROCEDURES
CNC must not contain:
synthetic aromatic substances pursuant to ISO 9235; synthetic preservatives except those explicitly permitted in Annex 1; paraffin, petroleum jelly and other similar petroleum derivatives; substances that have undergone a process of irradiation with an ionizing dose of energy in their production or during the CNC production; genetically modified materials and their products/derivatives; CNC Standards
SUBSTANCES PERMISSIBLE IN CERTIFIED COSMETIC PREPARATIONS
Annex 1 to the Standards includes an up-to-date list of permitted substances or
groups of substances. The Annex may be updated in accordance with latest scientific
findings. However, its updates shall have no effect on existing certifications.
The permitted extraction methods are: maceration, extrusion, filtering, centrifugation,
solar extraction, cold extraction, pressure or vacuum pressing, distillation using water
or steam at low pressures, decoction, leaching, infusion, bioleaching/fermentation,
Perfuming shall exclusively use natural essential oils (not their isolated components),
absolues and components explicitly listed in Annex 1 to the Standards, section
4. STORAGE, PROCESSING AND PACKAGING
Stored ingredients for CNC Organic must be labelled in a way that prevents mixing or
confusing them with substances non-compliant with the Standards.
The production of cosmetic preparations under the Standards has to be separated in
place or time from the production of uncertified preparations.
The packaging material shall advisably make maximum use of materials that are
recyclable, recycled or reusable.
The use of PVC and polystyrene as well as materials containing GMOs or GMO
derivatives (to be proven with a written declaration by the packaging manufacturer) in
the packaging is prohibited.
5.1. Identification of components
Proper identification of all the components on the label according to the INCI
(International Nomenclature of Cosmetic Ingredients) is essential to providing the
consumer with clear and accurate information and is a precondition for certification.
In order to provide the consumer with clear information on the specific content of
organic ingredients of cosmetic preparations that contain at least 10% of organic
ingredients, the manufacturer/first distributor (generally, holder of certification under
the Standards) may state the percentage of components from ecological agriculture
on the product packaging using the phrase “Contains X% of organic ingredients”, or
state the specific names and percentages of the organic ingredients contained. In the
latter case, the organic ingredients shall be denoted in the INCI or by names common
in the country/countries of distribution.
If any of the permitted preservatives are used, the label permanently attached to the
certified cosmetic preparation shall say “Preservatives: …”. The dots shall be
replaced with the name(s) of the preservative(s) permissible pursuant to Annex 1 to
the Standards, stated exclusively in the INCI.
A) If a product demonstrably complies with the parameters set in the Standards, or
contains up to 20% of an organic ingredient(s), the manufacturer/first
distributor/distributor (generally, the certification holder) may refer to it on the
packaging or in advertising as “CNC – CERTIFIED NATURAL COSMETICS” based
on a certificate issued and a contractual agreement with KEZ o.p.s. on granting the
right to use the trademark.
B) If a product demonstrably complies with the parameters set in the Standards and
contains at least 20% of an organic ingredient(s), the manufacturer/first
distributor/distributor (generally, the certification holder) may refer to it on the
packaging or in advertising as “CNC Organic” based on a certificate issued and a
contractual agreement with KEZ o.p.s. on granting the right to use the trademark.
6. FINAL PROVISIONS
6.1. Manufacturer’s duty
The manufacturer shall demonstrably prove that it has made persons involved in
producing the CNC cosmetic preparation(s) familiar with the Standards.
6.2. Compliance with the Standards requirements
By signing an “Inspection and Certification Agreement” with KEZ o.p.s., the cosmetic
preparation manufacturer pledges to voluntarily comply with the requirements of the
The CNC – Standards for Certification of Cosmetic Preparations are the property of
KEZ o.p.s. and must not be used, copied and reproduced without the proprietor’s
written consent. The trademarks CNC CERTIFIED NATURAL COSMETICS and
CNC Organic must not be used in product labelling or advertising without the
7. Enumeration of legislation in force
Regulation (EC) No 1223/2009 of the EP and of the Council on cosmetic products,
Commission Regulation (EU) No 655/2013 laying down common criteria for the
justification of claims used in relation to cosmetic products, as amended
Council Regulation (EC) no. 834/2007 on organic production and labelling of
organic products, as amended
Act no. 258/2000 Coll., on public health protection, as amended
The legislative regulations of the EC and the Czech Republic will be monitored
continuously and updated in the Standards.
Positive list of substances permitted for use in CNC production
Material Safety Data Sheets in compliance with Regulation (EC) no. 1907/2006 of the
European Parliament and of the Council concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) have to be furnished for all
ingredients that are classified as hazardous or contain hazardous substances in
excess of the limits defined by the above Regulation. If the ingredients are not
classified as hazardous, specifications that will allow KEZ o.p.s. to decide whether
they comply with the CNC criteria have to be furnished. In the latter case, KEZ o.p.s.
reserves the right to define the scope and type of such documentation.
CNC may only contain the following biodegradable substances:
Tensides, including solubilizers (emulsifiers and detergents)
All tensides, including solubilizers, used in CNC have to comply with the criteria for
final aerobic biological degradation in compliance with Regulation (EC) no. 648/2004,
Article 4 and Annex III, within 28 days for at least 60%. The content of petroleum
derivatives in soaps and shampoos must not exceed 2% of the total weight of the
product; the quantity may only comprise substances that are tensides by nature. In
addition, they have to comply with the ecological criteria for the award of the
Community eco-label to soaps, shampoos and hair conditioners (Commission
Decision of 21 June 2007, notified under document number C(2007) 3127).
The permissibility of tensides, being a group of surfactants, is determined by the
1. For substances not listed in the text below, the Standards shall also follow, to an
extent necessary for assessment, Commission Decision 2007/506/EC, establishing
the ecological criteria for the award of the Community eco-label to soaps, shampoos
and hair conditioners.
2. Tensides may only be used as the main washing components in preparations the
primary purpose of which is washing, cleaning of hair, skin or mucous membranes or
in preparations intended for combing and/or shaping hair.
Examples: stearic acid, palmitic acid and other acids originating from plant material,
including complex fatty acids
Examples: cetyl alcohol, stearyl alcohol, behenyl alcohol, etc.
Partial esters of sorbitol and fatty acids
Examples: sorbitan monolaurate, sorbitan monopalmitate, sorbitan tristearate, etc.
Examples: cholesterol and its esters, wool wax alcohols
Partial esters of glycerol with fatty acids
Examples: glycerol monostearate, glycerol monooleate, glycerol monostearate citrate
Glycerine sorbitan esters of fatty acids
Esters of fatty acids and saccharides, including polyglycerides
Examples: polyglyceryl methylglucose distearate, glucosides of fatty alcohols
Examples: sodium palmitate, potassium stearate, calcium oleate, zinc stearate
(soaps with the ammonia and aluminium groups are not permitted)
Other anionactive tensides:
Tensides based on a saccharide molecule and compliant with the requirements of
Commission Decision 2007/506/EC are permissible. Substances produced by
introduction of sulphuric acid to reactive mixtures are expressly not permitted, except
substances listed in Commission Decision 2007/506/EC.
Amphoteric (ampholytic) tensides:
Examples: alkyl betaines, glycerophospholipids (e.g., lecithin), sphingolipids
Hydrophilic solvents or hydrating agents of alcoholic nature
Water that has undergone any process of chemical or physical disinfection of
sterilization such as by irradiation by ionizing nuclear or non-nuclear radiation must
not be used. Ozonation is not considered an ionizing disinfection or sterilization
Primary, secondary and tertiary alcohols of plant origin (such as ethanol, glycerine,
sorbitol, inositol, glucitol) and their esters can be used. Perfuming ingredients of an
alcoholic nature are not considered solvents.
All plant-based acids that are permitted as cosmetic components by the Directive can
In addition to the sugar derivatives listed in the other categories, all types of
saccharides can be used, such as fructose, glucose, maltose, sucrose, amylose,
amylopectin, cellulose and its natural derivatives. Natural derivatives also include
saccharides and their derivatives normally occurring in nature and also produced by
microbial fermentation, such as gluconates and gluconolactone. For the purposes of
the CNC Standards, saccharides also include plant-based starches: conventional
potato starch, gum arabic, guar gum, and xanthan gum.
Amino acids and proteins
Amino acids, peptides or proteins used have to be demonstrably of plant origin.
Oleophilic solvents and other fatty components
Solvents include oils such as mixtures of glycerids of complex aliphatic acids
(acylglycerols) of plant origin (e.g., from soya).
Additional solvents are vegetable oils, such as sunflower, flax, maize, olive, evening
primrose, soya, cocoa, etc., which can undergo hydrolysis, hydrogenation,
esterification, transesterification, and other condensation reactions. When using
hardened hydrogenated fats made of vegetable oils, it has to be proven that the
content of the trans-unsaturated fatty acids is no more than 1% of the total content of
the unsaturated fatty acids.
The following fat-adding substances can be used as additional fatty
a) of plant origin: fatty acids, glycerophopholipds (e.g., lecithin, cardiolipin, phosphatidylinositol), sphingolipids including ceramids, stigmasterols and sitosterols, complex plant fats such as shea butter, squalene and its fatty plant derivatives; b) of animal origin: both types of beeswax (cera alba, cera flava), wool wax, wool
Naturally obtained oxides of biogenic elements that are permitted for cosmetic
preparations (e.g., zinc oxide, silicon dioxide, ferric oxide, calcium oxide, magnesium
Naturally obtained salts of biogenic elements that are permitted for cosmetic
preparations (e.g., sodium chloride, potassium chloride, magnesium chloride, calcium
carbonate, calcium sulphate, etc.).
Other inorganic components
Kaolin, bentonite, hectorite, diatomaceous earth, various types of sediments,
including mineral mud and akadama, and other mineral substances permitted for
Substances intended exclusively or mostly for colouring a cosmetic preparation, the
whole body or some of its parts by absorbing or reflecting the visible light; precursors
of oxidative hair dyes are also considered colourants.
Only colourants obtained from plant sources are permitted. Such colourants include,
among others, anthocyanins (E163), carotenes (E160a), chlorophylls a chlorophyllins
(E140), riboflavin (E101), and caramel (E150).
Substances added in order to affect viscosity
In addition to the above, plant mucinogenic polysaccharides(e.g., tragacanthin) and
alginic acid are also permitted.
Perfuming ingredients include substances and mixtures of substances added to a
cosmetic preparation with the primary purpose of modifying its fragrance.
Perfuming compositions may contain substances obtained from plants. CNC must
not contain any synthetic perfuming ingredients even where an identical substance
Perfuming ingredients must not contain any of the allergens listed in Schedule 7 to
the Directive. This requirement does not apply to natural essential oils.
Substances intended exclusively or mostly for suppressing the growth of
microorganisms in a cosmetic preparation.
In addition to the natural substances listed under the other groups in these
Standards, the following are permissible:
N-(1-Oxododecyl)-L-arginine ethyl ester chloride (INCI: Ethyl Lauroyl
If any of the above substances or a mixture thereof is used, it shall be identified on
the CNC label as follows: “Preservatives: …” The dots shall be replaced with the
name(s) of the preservative(s) listed above, stated exclusively in the INCI.
Substances intended exclusively or mostly for skin protection from certain ultraviolet
radiation by means of absorbing, reflecting or dispersing the radiation.
Only physical filters – zinc oxide, titanium dioxide, silicon dioxide – can be used for
intercepting the UV spectrum of photon radiation for the purposes of skin protection
or CNC colour stabilization. The ingredient manufacturer may only disperse the said
oxides in water or permitted fatty substances. Requirements on preservative
ingredients apply to their stabilization.
Only natural substances obtained from plants may be used as antioxidants. They are
primarily vitamins A, E, C. These vitamins can be esterified using a fatty acid. Only
substances listed in this Annex can be used as solubilizers or carriers for the
The natural origin (except animal origin) of any substances other than the above
used in CNC is crucial for assessing their permissibility. Examples of such
compounds include some substances in the isoprenoid group not yet listed, such as
caffeine, theophylline and cyclopenta-perhydrophenanthrene substances. They also
include some metabolic products of fungi (such as Pythium oligandrum).
Exemplary enumeration of processes in cosmetic preparation
production that are not eligible for certification
- bleaching – deodorization (supported by animal origin)
- use of enzymes obtained from GMO
- deterpenation (other than using steam distillation)
- ionizing radiation
- sulfonation (as the main reaction)
- methods employing genetic engineering
- treatments using mercury
- use of petroleum derivatives as catalyzers
Determining the content of synthetic ingredient component in a cosmetic preparation
SVi relative content of synthetic component ingredient i in the product
Si proportion of the synthetic component in ingredient i
Wi water content in ingredient i
Xi ingredient i content in the product
WA water added to the product
Si = Ai * Sv
Ai content of the active substance in question (pure chemical compound) in ingredient i as
per technical specification
Sv synthetic component content in the active substance determined by expert assessment
= the sum of water content in all the ingredients contained in the product
The cosmetic preparation composition is as follows:
- water 60% (WA)
- ingredient i 25% (Xi)
- ingredient z 15% (Xz)
The content of the synthetic component in the active substance of ingredient i is 80% (Sv).
According to the technical specification for ingredient i, its active substance content is 30%
(Ai); the remaining 70% is water (Wi). The water content in ingredient z is 50% (Wz).
What is the relative content of the synthetic component of ingredient i in the product (SVi)?
Si = Ai * Sv = 0.3 * 0.8 = 0.24, i.e., 24%
SUM[i=1, n](Wi * Xi) = (Wi * Xi) + (Wz * Xz) = (0.7 * 0.25) + (0.5 * 0.15) = 0.25, i.e., 25%
Xi * (1 - Wi) 0.25 * (1 – 0.7)
SVi = Si * ---------------------------------------- = 0.24 * ---------------------- = 0.12, i.e., 12%
1 - WA - SUM[i=1, n](Wi * Xi) 1 – 0.6 – 0.25
Conclusion: The cosmetic preparation contains 12% of the synthetic component of
ingredient i in question.
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