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• Safety assessment of cosmetic against EU, SASO, the FDA (the exposure assessment, risk components, compliance with the provisions of the composition, toxicology test results of finished cosmetic). • ISO22716, GMP - certification, implementation and training. • Environmental monitoring of production. • Making a list of ingredients, validation labels. • Assistance in preparation of the dossier of the product. • Compliance with European Union regulations for importers. • The legal basis of components usage. • Quality inspections before shipment, audits of suppliers. • Training on legislative issues in the cosmetics industry. • Laboratory tests and interpretation of results – microbiology, sensory testing, physicochemical tests, Challenge test on the effectiveness of the methodology of preserving cosmetics FP EU. • Support on entering new markets of America, Asia and Europe (meeting legal requirements).
Intertek facilities are available for toxicological studies, analytical studies on carcinogenicity, pathology, environmental management and quality assurance and product development research. Intertek applies to European Union regulations concerning the safety of cosmetic products (Directive 76/768/EEC and Regulation of the European Parliament and Council (EC) No 1223/2009), which are fully applicable to all cosmetic products manufactured in the EU or imported into it. It covers all aspects, from the normal manufacturing process "Good Manufacturing" (GMP) to assess the safety, packaging and labeling.
Intertek Poland ul. Jutrzenki 177, 02-231 Warszawa tel. 48 22 873 90 45; fax 48 22 863 33 15 www.intertek.pl
contents APPLICATION OF ATOMIC FORCE MICROSCOPY
cover stroy
in contemporary cosmetology
– European Requirements
14
Cosmetic Product Information File
11
inter interview view view... ...
8
In harmony with nature. 50 years have passed
14
Cosmetic Product Information File – European Requirements
18
THE EUROPEAN PARLIAMENT AND THE EUROPEAN COUNCIL REGULATION NO 1223/2009/WE OF NOVEMBER 2009
cover story story
CONCERNING COSMETIC PRODUCTS – THE LATEST NEWS 22
11
RESEARCH AND DOCUMENTATION ON COSMETIC PRODUCTS ACCORDING TO THE
APPLICATION OF ATOMIC FORCE
EUROPEAN PARLIAMENT AND THE EUROPEAN
MICROSCOPY in contemporary cosmetology
COUNCIL REGULATION NO. 1223/2009/WE CONCERNING COSMETIC PRODUCTS 26
1/2012
Stability testing of cosmetic products Part 1
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Stability testing 26 of cosmetic products Part 1
Moisturising 44 Role of packaging compatibility testing during implementation of cosmetics
an essential element of skin care 41
38
Determination of liposome particles size by use of dynamic laser light scattering method
28
41
Moisturising an essential element of skin care
44
Role of packaging compatibility testing during
Evaluation of disinfectants effectiveness in cosmetic industry – testing methods and necessity of testing
31
In vitro alternative methods of eye irritation tests. Part 1
34
implementation of cosmetics
How to reduce cavitation in homogenizers of a vacuum processing unit
36
The charm of perfumes – alternative scents versus famous perfume brands
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47
Health and beauty stores drive cosmetic market’s growth
1/2012
Dear Sirs and Madams Maria Kubsz-Łatas editor of issue „World Of The Cosmetic Industry”
I would like to introduce the next Polish-English issue of the “World of the Cosmetic Industry” quarterly, which will be distributed at numerous fair events in Poland and abroad. It will include, among others, an article about the role of packaging compatibility tests during the implementation of cosmetics. I also recommend an article about cosmetic products’ stability tests. I would like to invite you to the third edition of the “World of the Cosmetic Industry” Congress, which will be held in October. More information soon. Looking forward to your participation!
Programme Board:
List of advertisers:
Anna Oborska PhD
Ewa Starzyk
„MEDsynC Skotnicki, Weksler” Sp. j.
– Polish Association of Cosmetics and Home Care Products Producers
– Scientific Director at Polish Union of Private Employers of Cosmetics Industry
„Lucad” Biuro Techniczno Handlowe Aniflex Sp. j. Głowacka i Wspólnicy AREXIM Packaging Bech Packaging Sp. z o.o. Biesterfeld Chemia Specjalna Sp. z o.o.
Quarterly, published by FARMACOM Wodzisław Śląski 44-300 ul. 26 Marca 31/11 farmacom @farmacom.com.pl www.farmacom.com.pl Editor-in-chief: Robert Miller tel./fax 32 455 31 61 tel. kom. 502 084 101 robert.miller @farmacom.com.pl Editor of issue: Maria Kubsz tel./fax 32 456 60 79 tel. kom. 510 40 31 91 maria.kubsz@farmacom.com.pl
Subscription and distribution: tel./fax 32 455 31 61 prenumerata@farmacom.com.pl
Cosmetosphera Dr Piotr Koziej Centrum Kosmetyków Sp. j.
Issue price „ŚPK” – 10 zł Annual subscription price – 35 zł Payments may be made to the account: ING Bank Śląski O/Wodzisław Śląski 56 1050 1403 1000 0023 2091 8119
DSM Nutritional Products Sp. z o.o
Editors: Tomasz Butyński, Teresa Kubsz-Miller, tel./fax 32 455 31 61 redakcja@farmacom.com.pl
MIKROLAB Certyfikowane Laboratorium Badania Produktu GMP/GLP
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Intertek Poland Sp. z o.o. Laboratorium Ella MEPING Witold Seklecki i Maciej Sworzyński S. j.
P.W Masterchem S.J.
Trade&Consult Ltd. Sp. z o.o. Sp.k. Zako ABM Sp. z o.o. The magazine is addressed to process and production engineers, automatic systems specialists, heads of production, control and quality assurance divisions, heads of logistics and procurement divisions and product development divisions at pharmaceutical companies. The magazine is also purchased by organizers of trade fairs, conferences and industry training courses, government offices, ministries, institutes, higher educational institutions offering pharmaceuticals-related courses, and design firms. The editors reserve the right to shorten and edit material. The editors are not responsible for the content of advertisements. The use of materials and publication of advertisements produced by the publisher is permitted only with the editors’ consent.
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in harmony with nature
8 | interview...
50 years
have passed Larysa Dysput - owner of AVA Cosmetics Laboratory Bożenna Mirkowska, Msc – cosmetologist, process engineer at AVA Cosmetics Laboratory
Larysa Dysput
Bożenna Mirkowska
Laboratorium Kosmetyczne AVA
Laboratorium Kosmetyczne AVA
Last year AVA Cosmetics Laboratory celebrated its 50th birthday. Could you recapitulate half a century of its activities?
spas. Our products are exported to countries where ecological awareness
L.D. AVA Cosmetics Laboratory is a Polish, family-run business, with half
market, as we want to produce high quality active cosmetics available to
a century of tradition and experience. We specialise in development and
Polish women at an affordable price.
is higher than in Poland, e.g. USA, Canada, Australia, Spain, United Arab Emirates, United Kingdom and Hungary. However, we focus on the Polish
manufacturing of functional face and body cosmetics, both for retail and
-handedly for 25 years. I took over for the following quarter of the century.
The „Eco” trend in Poland has just only emerged. Why ecological cosmetics and how did you know that it was going to be the right choice?
The first line of cosmetics, introduced 50 years ago was AVA Mustela - a
L.D. We came up with the idea during a conversation with our Australian
hypoallergenic emulsion with anti-wrinkle properties. It has been continu-
clients. They persuaded me to develop ecological cosmetics. That idea also
ously manufactured ever since and today still enjoys a good reputation
reflected our philosophy and our mission. We were the first Polish company
among our clients. Every year a new line of cosmetics was lounched. More
to introduce certified natural cosmetics to the Polish market, and one of the
formulas containing innovative ingredients were continuously developed
first to start developing paraben and silicone free formulas. The first ECO
and improved. It is vital that our cosmetics contain active, skin-friendly
Linea ® line was launched by AVA Cosmetics Laboratory in 2008. Eco trend
ingredients while remaining effective. We are recognised for not following
is growing increasingly popular in Poland, but the awareness is rising very
other companies’ ideas, but for developing our own formulas based on
slowly. Cosmetic companies have also appreciated the potential and started
natural resources. ‘In harmony with nature’® has been our motto from the
launching cosmetics made of natural ingredients. However, AVA is one step
very beginning. We are the first Polish company to be awarded ECOCERT
ahead and provides fully natural, organic cosmetics, certified by ECOCERT.
certificate and a licence for manufacturing ecological cosmetics: three
We all want to remain young and fresh looking as long as we can. We all
lines of natural and organic cosmetics for retail distribution and one for
use functional cosmetics and we would like them to be safe, effective and
professional use. Together we manufacture 120 types of cosmetics for
free from parabens, silicone, extracts from genetically modified plants and
retail distribution and approximately 100 types for beauty salons and health
artificial colouring.
professional use. It was founded in 1961 by my mother Irena Dysput, who was a qualified pharmacist. My mother had run the company single-
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interview... | 9
You have launched a new, certified organic line of cosmetics ECO Garden. What gave you the idea to include vegetable extracts in the formula?
crops, have appropriate certificates, and have similar structure to our body cells.
B.M. The nature is an unlimited source of active substances, supporting
have negative impact on our skin and can result in weakening of the immune
natural protection system and healing processes taking place within the skin.
system and lack of skin’s self-regulation abilities. Ecological cosmetics are a
Even ancient beauties relied on natural resources to preserve their beauty
good investment in the future of your skin – they will help it regenerate well
– they bathed in milk and honey, moisturised their bodies with scented oils.
and become less irritable. The effects of ecological cosmetics last longer than
Even then people realised nature’s salutary influence on the skin. Essential
conventional cosmetics because the skin is supplied with natural ingredients
oils obtained from plants can also have a very strong influence on our psyche,
which enhance its natural protection system and natural healing process and
and therefore on our well-being. It is obvious that we reach for ecological
also supply vital energy.
They can adjust to the natural rhythm of our skin and meet its needs. However, the effects are visible slightly later than with conventional cosmetics. The skin needs to readjust, as synthetic cosmetics contain numerous substances which
cosmetics, especially when it comes to skincare and body care.
ECO Garden line. Tomatoes are natural antioxidants and, thanks to lycopene
How are natural cosmetics preserved and do they have a shorter expiry date than conventional cosmetics?
content, help maintain youthful look. Cucumber is very refreshing, has the
B.M. Safety requirements for cosmetics do not allow for complete lack of
same pH as our skin and therefore has beneficial influence on its natural
preservatives. It is acceptable to use preservatives from a list of substances
condition. Carrot gives the skin an appropriate colour and it contains beta-
recommended and approved by ECOCERT quality standards. Certified
carotene which nourishes and regenerates the skin, protecting it against free
natural cosmetics contain nature-identical preservatives which they have an
radicals and UV radiation. Green peas contain phytohormones, minerals
equivalent in natural resources, e.g. benzoic acid derivatives are obtained from
and vitamins helping maintain natural beauty and nourish the skin. Recently
cowberries; salicylic acid comes from white willow. However, that must be
cosmetics based on plants and vegetables have become very trendy. They
clearly stated on the packaging. Manufacturers are also keen to use natural
take full advantage of the nature’s strength; they are very delicate and efficient
preservatives such as grapefruit seed extract or natural essential oils. The
at the same time. List of ingredients looks like a recipe for a delicious salad.
right combination of preservatives helps maintain freshness of cosmetics and
Mouth watering and great for the skin.
is safe for the skin. It is very important to close the packaging tightly each time
Many plants known for their culinary use also have great skin caring properties. That is why we decided to use Polish vegetables in our new
after usage in order to avoid humidity condensation which promotes fungal
Certified natural and organic cosmetics are certainly more healthy for our skin. Are they as effective as conventional preparations?
and bacterial growth. It is also very important to remember the following:
B.M. Certified natural and organic cosmetics are made of highest quality
• expiry date stated on the packaging must be observed.
• natural cosmetics must be stored in room temperature • cosmetics must be kept away from direct sunlight and humidity
natural ingredients. They are free from animal components, extracts from genetically modified plants, parabens, silicones, artificial colouring or scents. They are safer for us and for the environment. They do not cause allergies and, thanks to the highest quality active plant ingredients, they enhance the skin’s
Is it difficult to obtain the ECOCERT certificate? What requirements does a manufacturer have to meet?
protection system and its natural healing processes. They are effective and
L.D. ECOCERT certification standards are very restrictive and involve a lot
pleasant to use, because plant components come from supervised ecological
of effort in order to obtain approval for the formula and principles of production,
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10 | interview... the process very strictly. At the time of the launch each product must come with documentation containing safety assessment carried out by a qualified and experienced Safety Assessor with extensive knowledge of composition and performance of cosmetics. The assessment is prepared on the basis of detailed toxicology testing of all components of the given cosmetic. Each product is subjected to physicochemical,, microbiology and dermatological testing. There are no safer or less safer groups of cosmetics! Each product’s safety must be individually assessed. The analysis covers both the raw material documentation and all other existing information: chemical and medical publications, toxicology databases and official documentations from various institutions such as Scientific Committee on Consumer Products. The assessment covers chronic (systemic) toxicity, carcinogenic and mutagenic activity, adverse influence on reproduction and topical effects packaging, marking and storage of both raw materials and end products. The
(irritation and allergy).
certification process covers not only the natural or organic product itself, but
Ecological cosmetics have a better effect on the skin because they
also the factory where the cosmetics are produced. Manufacturing licence
enhance rather than fight natural skin processes. The results come less
for certified natural and organic cosmetics is valid for 1 year and granted
quickly than with most conventional cosmetics where the short-term
following an audit carried out by an ECOCERT certifying body.
effect seems to be immediate (mainly thanks to silicones), but when
Only products with at least 95% of natural ingredients qualify for the „Natural and organic cosmetics” quality mark. Extracts from plants grown
used systematically, ecological cosmetics provide permanent, long lasting results.
in monitored organic crops are processed only by physical rather than from genetically modified plant extracts, dead animals, petrochemical
How are the raw materials and end products tested?
components, synthetic odorants or dyes, or synthetic preservatives. Animal
L.D. Manufacturers are obliged by law to carry out appropriate end
testing is forbidden. Cosmetics ready for distribution should be placed
product testing. The main aim is to prove the safety and verify marketing
in eco-friendly, recyclable packaging. The production process must be
declarations. The legislation does not list specific obligatory tests, so it is
environmentally friendly.
the manufacturer’s decision what testing will be done. It is important that
The packaging must contain the following information:
manufacturers choose appropriate tests and that they are honest towards
• category of cosmetics: natural, organic
the clients. For that reason, a number of tests have been prepared and
• mark of the certifying body
divided into three categories:
• information on percentage of natural ingredients and certified ecological
• Conformity tests – to prove safe use of the given cosmetic
chemical methods. The products must be free from raw materials obtained
components.
• Acceptance tests – to state whether the expectations regarding the product have been met
The world of fashion is known for its seasonal fashion trends. Is it also the case with the cosmetic industry?
• Testing with the use of instruments and systems – to verify marketing declarations objectively. • Conformity test are divided into in vitro testing and testing on voluntary
B.M. Yes. Competitiveness of cosmetics depends mainly on innovative
participants. They are based on an appropriate questionnaire prepared
use of an ingredient whose new properties have just been discovered.
by the manufacturer. As they test the given cosmetic, the volunteers fill
Development of a new line of cosmetics depends on market expectations.
out the questionnaire, as instructed by the manufacturer. These results
Ingredients are chosen to meet the new product’s needs, and to make it
form basis for marketing declarations. However, the manufacturer may
effective. European olive oil as well as extracts from water-lilies and exotic
decide to carry out the tests which are irrespective of subjective feelings
plants are often used nowadays, but on the other hand traditional ingredients
of volunteers. Then they can choose from a number of methods involving
such as marshmallow or vegetables are becoming increasingly popular. I
the use of appropriate instruments or systems.
used carrot, cucumber, green peas and tomato extracts in our latest line of cosmetics AVA ECO Garden. They are well tolerated by sensitive skin and do not cause allergic reactions.
AVA cosmetics are not tested on animals. Furthermore, as we purchase certified raw materials, we can be sure that they were not tested on animals, even if they come from Americas and not from Europe. Animal testing is
What are the characteristics of high quality safe skincare and body care products?
forbidden in Europe (EU) and therefore that information is not featured on the
B.M. Cosmetics cannot be a health hazard – that is the key requirement
to have that information.
packaging. However in USA animal testing is still allowed, so it is important
which must be met before the product is launched. Legislation governs
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cover story | 11
APPLICATION OF ATOMIC FORCE MICROSCOPY in contemporary cosmetology Bożena Tyszczuk Centrum Naukowo-Badawcze Dr Irena Eris
Over the recent years there has been growing interest in the practical application of numerous state-of-the-art measurement techniques in the cosmetic industry which make it possible to verify the efficacy of action of both raw materials and finished cosmetic formulations. Nowadays expecting not only assurance that the cosmetic products, offered by manufacturers, have a favourable impact on their appearance, but also demand confirmation of such claims through scientific studies. This leads to closer co-operation between research entities and industrial partners which in turn fuels the development of new measurement methods with an immense application potential in cosmetology.
A tomic Force Microscopy (AFM) is one of the latest techniques
The AFM may operate in three modes: contact, non-contact
currently used for the confirmation of the efficacy of cosmetic products.
and tapped mode. In contact mode, the probe is in direct contact
The AFM is a member of the class of scanning microscopes which scan
with the sample. While scanning the sample surface, various types
the sample surface using a probe (Figure 1) [1]. The probe is in the form
of information can be simultaneously collected, such as: sample’s
of a spike attached to a flat spring (so-called micro-beam). The probe
topography, spring deflection or friction between the probe spike and
spike moves over the sample surface which leads to changes in spring
the sample. The tapped and non-contact modes are used when direct
position and its deformation. Any deflection of the spring is recorded by
contact between the probe and the sample could lead to its damage
an optical system; the measurement result is subsequently converted
(low hardness samples).
into a voltage signal. The image of the sample’s surface topography
An advantage of AFM in biomedical research is the possibility
is obtained by mapping converter extension values for each probe
of performing studies in liquids and at physiological temperatures [1].
location on the sample. In addition, each spring deflection – even a minor one – is recorded, and as a result the sample topographic image can be generated in very high resolution.
AFM in studies of the condition of hair shafts An example of AFM application in cosmetology is the study of changes in hair shaft morphology which occur due to the use of a conditioning product. Hair samples collected by selected subjects with hair damaged due to hairdressing and beauty treatments were used for the study. Being the outermost part of the hair shaft, the hair cuticle is the most exposed to such damage. Samples for the analysis were taken before application of the cosmetic product and after single application of the conditioner for damaged hair. The studies of changes in the condition of hair shafts were performed using two techniques: Scanning Electron Microscopy (SEM) and Atomic Field Microscopy (AFM), see above. Scanning Electron Microscopy enables only visual observation of changes which occur in the morphology of tested samples. It is a macroscopic technique
Figure 1. Schematic of atomic force microscope (AFM)
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which fails to deliver quantitative results for the changes which occur
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12 12 | production cover story
in the tested material. Therefore, AFM was used as a complementary
product particles accumulated mainly in the hair cuticle pockets: at the
technique. This technique is extremely precise and provides results in
base and between the hair cuticle cell layers. They filled losses resulting
nanoscale (Figure 2).
for example from thermal (drying, straightening), chemical (colouring, brightening) and mechanical processes (modelling, combing) associated with daily hair care.
Friction The voltage measured by the optical system was used to evaluate friction at the cuticle surface. The average friction value was determined by the computer software developed by the AFM manufacturer. After conditioning product application, increased friction was recorded both in the dry and humid environment. This phenomenon, discussed in literature [4,5], is accounted for in the following way: the cosmetic formulation in the nanoscale causes micro-beam spike sticking to the hair surface which causes increased friction. The friction at the edges of cuticle cells (scales) was evaluated by Figure 2. Morphology of hair cuticle cells in the atomic field microscope after application of a hair conditioner
the analysis of friction values recorded at friction image cross-sections. Friction at the cell edges was compared with average friction. The results suggest that friction forces at the hair cuticles achieve their maximum values just at the edges. Similarly as for friction at the cuticle
The following data could be acquired within the study: roughness,
surface, friction values were also higher after conditioner application.
friction at the surface of the hair cuticle and on its edges (colloquially
This confirms the fact that conditioner deposits form at the base of
called scales) and their height (or the distance from the hair shaft
cuticle layers.
surface).
The height of the cuticle cells was analysed by cross-sections of their
a)
b)
Figure 3. Surface topography of corneocytes taken from skin not treated with the cosmetic product, (a) and treated with the cosmetic product (b)
Roughness
topography images. The height between the cell base and their edges
In order to determine the average roughness, a topography image
was measured. It was noted that the hair scale height increased after
was acquired for each sample, whereby a specific height was assigned
conditioning cosmetic product application. The measurements were
to each point. Average hair roughness was defined as the difference
carried out in deionised water. Hair surface is negatively charged, while
between the average height of the resulting image and the height
the conditioner being deposited is positively charged. When the water
at a given point. The image of the scanned hair surface proved the
is present, its polar molecules surround and penetrate points where
existence of cosmetic product particles on the surface of hair cuticles.
the hydrophilic cosmetic product aggregates. Deflection of the hair
The occurrence of such deposits in the nanoscale leads to increased
cuticle cells may also occur under the influence of mechanical stress
surface folding which means increased roughness. The observation is
which builds up due to differences in water contents in respective hair
consistent with the previous studies of the parameter [2,3]. Cosmetic
cuticle areas.
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cover story | 13 AFM in ex vivo studies of epidermal cells
The measurements included also adhesive forces. The procedure
Ex vivo analysis of epidermal stratum corneum cells (corneocytes)
was based on the estimation of the force needed to detach the AFM
is another example of how atomic force microscopy can be used in
spike from the test surface - here the corneocyte surface. The study
cosmetology. Atomic force microscopy technology is used for the
results indicated a distribution of adhesive forces occurring between the
evaluation of differences in topography, elasticity and corneocyte
scanner spike and cell surface which was similar as for Young’s modulus
adhesion forces. The test material was collected from the skin surface
values. A fraction characterised by stronger spike-surface interactions
of volunteers by tape-stripping. This involves the collection of epidermal
was recorded for samples taken after the cosmetic treatment.
cells using special disks made of adhesive tape. The tested cells are
The AFM analysis of corneocytes taken by tape-stripping proved
made up mainly from creatinine, with a diameter of approx. 4 µm and
that they became smoother, more rigid, with stronger adhesive bonds
thickness of about 0.1 µm. Test samples were taken from a 30-year-old
between them following the cosmetic treatment.
woman before the start of the cosmetic treatment and after 5 days of
AFM in in vitro studies of epidermal cells
use of a moisturising cream.
Epidermal cells may also be analysed using AFM in in vitro
Changes in the morphology of the cells themselves were the first
conditions. The tests were performed on live epidermal cells isolated
corneocyte feature evaluated (Figure 3). Corneocyte surface was
from skin slices taken from women in the following ages: 20, 40 and
smoother following the application of the cosmetic product.
60 years. Control cells (cultured in the growth medium only) and cells
The analysis included also Young’s modulus measurements. Young’s
grown in the presence of peptides used in anti-wrinkle formulations
modulus is a measure of elasticity (flexibility) of the tested material. The
were tested for each age group. The objective of the study was to
Young’s modulus of corneocytes was determined based on recorded
evaluate the effect of the peptides on cell topography (Figure 4) and
force-distance curves, or correlation between the deflection of a
determination of their Young’s modulus.
spring and the relative position of the piezoelectric scanner on which
The determination of Young’s modulus was carried out in a liquid chamber in which tests can be performed in physiological conditions (in the growth media in which the cells were cultured). The analysis involved the measurement and evaluation of force curves. Deflections of the arm with the spike from the piezoelectric scanner with the sample were monitored. The deflection corresponds to the force exerted between the end of the spike and the surface of the sample. Surface elastic properties are characterised by the relationship between indentation and force. Most materials deform in an elastic or plastic manner. Living tissues, such as cells, are particularly susceptible to such deformation. When there is no sample surface deformation, the indentation value is zero. For cells, small deflections of the arm with the spike are noted, caused by the deflection of the elastic surface under the force exerted (indentation forms). Indentation values are calculated by comparing the
Figure 4. Topography, feedback signal from the controller and friction, 3D image
values obtained for ideally hard materials (such as glass in the growth vessel) with those obtained for an elastic material (living cells). The AFM imaging of the test cells was performed in the contact mode. The initial results showed that Young’s modulus values were
the samples were located. Spring deflection corresponds to the force
greater for epidermal cells grown in the presence of the peptide and
magnitude exerted between the probe spike and the surface of the test
taken from 20- and 40-year old subjects, and the strongest reaction
sample. The JKR (Johnson-Kendall-Roberts) model [6] was used for
to stimulation with the cosmetic ingredient was noted for cells taken
the determination of Young’s modulus, assuming an indentation depth
from the 40-year-old subject.
of 10 nm (according to literature data related to corneocyte studies) [7]. The study results prove the existence of statistically significant
Summary
differences in the mechanical properties of corneocytes taken after
The examples of the application of the atomic force microscopy
cosmetic treatment compared to control samples. Control corneocytes
discussed above are the most recent published examples of its use in
(not treated with the cosmetic product) were more rigid than corneocytes
cosmetology. Studies using atomic force microscopy facilitate reliable
taken after the 5-day cosmetic treatment. It was demonstrated that
and extremely precise determination of the effect of cosmetic products
two Young’s modulus fractions can be determined in the corneocytes
(hair care formulations and w/o and o/w cosmetic emulsions) or specific
taken after the cosmetic treatment: with rigidity similar to the control
active ingredients used in cosmetic industry on the condition of skin
and more rigid. Fractions with higher Young’s modulus values were
and hair.
located at the cell surface.
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14 | production
THE EUROPEAN PARLIAMENT AND THE EUROPEAN COUNCIL REGULATION NO 1223/2009/WE OF 30 NOVEMBER 2009 CONCERNING COSMETIC PRODUCTS – THE LATEST NEWS dr Piotr Koziej Centrum Kosmetyków Dr Piotr Koziej
After many years of thorough research, debates, and consultations on the European level new Polish Act on cosmetics was published and from the date of 11 July 2013 the European Parliament and the European Council Regulation No 1223 / 2009 / WE concerning cosmetic products (OJ UE L 342 of 22.12.2009, p.59) shall be in use. The main aim of the aforementioned regulation is to appoint uniform procedures, terminology, and the principles to launch cosmetic products and, ultimately, to standardize law regulations concerning safety of cosmetics and to ensure health protection to people. Appointing the following regulation means that both cosmetic manufacturing and cosmetic marketing are currently regulated on the European level.
The regulation no 1223/2009/WE guarantees a standardized law regarding
may constitute some challenges for small businesses. Adapting the
cosmetic products both for the controlling bodies of these products as well as
documentation of the cosmetic product along with its safety evaluation,
for the producers of these products in all Member States of the European Union.
notifying the product in the central notification system of cosmetic products,
Furthermore, the notification introduced by provisions of the regulation of
production in accordance with GMP (Good Manufacture Practices), or tracing
the cosmetic product in the system of notification of cosmetic products shall be
products in the supply chain constitute just a few of the challenges to be met.
undertaken in a central manner. In view of it, the trader who releases a particular
A significant change lies within introducing a new definition of the person
product on the market in one of the Member States of the European Union will be
responsible, the manufacturer, the importer, and distributor and defining their
able to sell it without having to meet any additional requirements within the Union.
responsibilities, and hence:
In the legal provisions of the regulation no 1223/2009 new definitions and
• The person responsible shall guarantee that each and every cosmetic
responsibilities were drawn up. The established definitions and responsibilities
product marketed is complied with appropriate requirements set out in
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15 the regulation no 1223/2009. According to the definition, this might be
• if a given cosmetic product is not complied with the requirements provided
the manufacturer or the importer who assumes the legal responsibility
in the regulation, the product is not accessible on the market until
for the product.
it is adapted according to current regulations.
• T he manufacturer – shall mean any natural or legal person who manufactures a cosmetic product or has a particular product designed, manufactured, and then releases the product under their own name or
Notification of cosmetic products The regulation no 1223/2009 also establishes the proceedings that are connected with a notification of cosmetic products. The Central Notification
trademark. • The importer – shall mean any natural or legal person who resides
System of Cosmetic Products has been founded, the one for the whole
within the European Union and releases the product within the Union
European Union - CPNP - Cosmetic Products Notification Portal. Notification of
from a third country.
cosmetic products shall take place electronically to unify and simplify already
• The distributor – shall mean any natural or legal person in a chain supply
existing procedures. A current notification in National Notification System of
who is neither the manufacturer nor the importer and they make a cosmetic
Cosmetic Products shall be no longer needed - applications shall be sent
product accessible within the European Union market. The Distributor
once for all products sold in the European Union. The manufacturer will not
is responsible for the compliance with the provisions of the language of
have to notify each of their products, for example in Germany, Spain, or in
the country concerned. They are responsible for notifying the products
Slovakia. A scope of a notification process is bound to be altered. One shall
that originate from outside the European Union in the central system
need such information as:
of notification of cosmetic products – CPNP. The significant change is
• the name and category of a cosmetic product,
also connected with imposing the obligation on the distributors to trace
• the address of keeping the documents (product dossier) ensuring a
every batch of products (traceability). In practice, the manufacturers of
substance’s safety,
cosmetics ought to place lot numbers next to the names of products in
• the substance existing in a nanonuclear form,
the documentation of their sales to distributors. The Distributor ought to, in
• the foreseeable routes of exposure,
turn, keep a record with information about the distributors or the persons
• the contact data and the people responsible,
responsible from whom he/she had acquired a cosmetic product, and
• the country of origin in the case of the imports from outside the EU,
the distributors who sold the product. The above obligations imposed
• the Member State of the product being first marketed,
on the manufacturers and the distributors of cosmetic products are to
• the photograph of a product,
ensure the maximum safety of cosmetics, especially in the case of the
• the framework formula.
withdrawal of a product from the market. One is, then, certain where the The distributors, as it has been previously mentioned, shall need to notify
product is located.
cosmetic products that come from the outside of the European Union. Moreover, in the provisions of the regulation no 1223/2009 oversight services and a scope of their access to the data notification have been stated so that the manufacturers would be sure that their recipe would not become public information. Notification of cosmetic products in Cosmetic Products Notification Portal is already running and you can enter all the products that will be available on the market after 2013, After 2013, if the oversight services encounter a product which will not be reported, the product will be immediately withdrawn from the market. Producers have two years to adapt the documentation of their cosmetic products to the new requirements and report them to the Notification Portal. The requirement of production complied with GMP (Good Manufacture Practices)is new for some companies. In 2007, standard ISO 22716: 2007 was published which contains guidelines for the production, control, storage, and transport of cosmetic products. The guidelines include significant aspects related to the quality of the product. However, they do not include safety For distributors, in accordance with the new provisions, the following
aspects for the personnel who is employed in the establishment. They do
responsibilities have been imposed:
not include environmental aspects, neither. ISO 22716: 2007 guidelines do
• tracing the route of cosmetic products
not apply to research and development activities or to the distribution of
• checking rules of a language in accordance with requirements
products already manufactured.
• m arking the product in an appropriate way in accordance with requirements • checking the expiry date
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The regulation no 1223/2009 assumes the obligation to adapt existing documentation of the cosmetic product to the required scope of the
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documentation, consisting of a safety assessment. The documentation
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16 | production
ought to be updated after the introduction of the product on the market, for example after having performed additional tests. The documentation must
• an assessment of the impact of the cosmetics’ storage on its safe application,
be stored for 10 years.
• Safety Assessor’s specific data
A new safety assessment consists of:
• the computed safety margins for each component of the product,
• Part A: information about the safety of cosmetics
• the characteristics of the ingredients used.
• Parts B: safety assessment (prepared by Safety Assessor). Additionally, in the dossier (the full documentation) of the cosmetic product Part A should contain such information as:
there should be such documents as:
• the contact data of the person responsible,
• the results of physical and chemical tests,
• the people responsible for the production, confection, quality control,
• the results of microbiological tests,
• the place of the production,
• test results of challenge test,
• the description of the technological process complying with the principles
• the results of dermatological patch tests,
of GMP, • the formula of the product, • the quotient calculation of jeopardizing individual components,
• the results that prove the activity of a product (application test) • the results of the studies that prove the effectiveness of solar filters (SPF, water- repellency, phototoxicity, photoallergy, photostability, etc.),
• the foreseeable risk to human health,
• submitting an entry to appropriate registry,
• the cleanness and remains of the product,
• the contents of the labels and marketing materials.
• the possible interactions of the components of the product. Safety Assessor is required to have professional experience and they need Part B contains the following information:
to be an expertise in order to make a correct, complete, and reliable evaluation.
• the final safety assessment,
They ought to also have constant access to toxicological databases which
• Safety Assessor’ reasoning,
are continually updated according to the latest scientific publications in the
• thorough assessment of toxicological components,
given field.
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Centrum Kosmetyków Dr Piotr Koziej is a laboratory that combines the latest technology with the professional equipment and is based on a vast experience of various professionals from many fields of medicine. We provide comprehensive testing of cosmetics and household chemistry products. In our laboratory we conduct tests on standard products, special-purpose, professional, sensitive or products for children.
Safety Assessment – evaluation of the impact of cosmetic on the safety of human health, conducted according to the latest EU guidelines. Microbiology – a test that confirms a biocidal effect of cosmetics, household chemicals and other products, conducted using the methods listed in European standards and recommendations of COLIPA. Challenge test – conducted in accordance with European pharmacopoeias, in consultation with the client. Depending on your needs of the research modifications of the method of the test are introduced and individual performance criteria is chosen. Dermatology: Patch tests (open, semi-open, closed) Photo patch tests – phototoxicology and photoallergy Tests of the skin tolerance in the place of application RIPT (Repeated Insult Patch Test). Application evaluation: Individual selection of the subjects depending on the characteristics and the purpose of the product Large group of subjects depending on the client’s order Tests of the skin tolerance in the place of application. Individual, subjective evaluation from each of the subjects: – Evaluation of the products’ usability – Evaluation of the manufacturer’s declared effects. The tests might be accompanied by an additional specialist, e.g. a gynaecologist, an optician, an allergologist or other professional.
www.koziejcentrum.pl
The apparatus evaluations: Objective evaluation of the impact of the tested products on skin and assessment of the functional properties of product declarations. Courage&Khazaka apparatus – measures the following parameters: moisturizing, TEWL, sebum, pH, pigmentation (erythema and hyperchromia), temperature and flexibility. The results are prepared in the form of the graphs, tables, descriptions. Miravex Antera 3D™ apparatus and VisioFaceQuick apparatus - measure the following parameters: the size and depth of wrinkles, pigmentation (erythema and hyperchromia), smoothening, level of pores, UV. The results are prepared in the form of graphs, tables, descriptions, photographs. Thermographic evaluation - the study aims at thermal skin evaluation, providing information on blood supply for the subcutaneous tissue. It is often used to study the severity of cellulite and its treatment effects. UV evaluations (UVA i UVB): Using in vivo method in accordance to COLIPA (guideline 2007), BOOTS (2008 revision) lub FDA: – UVB - SPF test – UVA - UVA/UVB test – photostability test – water resistance test – photoallergy and phototoxicity test (Photo Patch Tests). Quick and useful test in the process of formulation (results up to 3 days). Using in-vitro method according to COLIPA and FDA standards: – UVB - SPF (in-vitro) test – UVA - PPD test.
Centrum Kosmetyków Dr Piotr Koziej
Diagnostic Test
ul. Bodycha 51, 05-816 Michałowice, Opacz-Kolonia tel.: +48 22 723 91 24
ul. Nowy Świat 17/5 15-453 Białystok tel. +48 85 744 58 84
biuro@koziejcentrum.pl
www.diagnostic-test.pl
biuro@diagnostic-test.pl
18 | production
RESEARCH AND DOCUMENTATION ON COSMETIC PRODUCTS ACCORDING TO THE EUROPEAN PARLIAMENT AND THE EUROPEAN COUNCIL REGULATION NO. 1223/2009/WE CONCERNING COSMETIC PRODUCTS Justyna Koziej Centrum Kosmetyk贸w Dr Piotr Koziej
From the day of 11 July 2013 the new regulation of the European Parliament and the European Council no 1223 / 2009 relating to cosmetic products (OJ UE L 342 of 22.12.2009, p.59) shall be in force. The principal purpose of the regulation is to unify legal provisions concerning cosmetic products existing in the European Union. This, in consequence, will lead to ensuring safety for human health.
The regulation no 1223/2009/WE introduces a number of changes
third country. The responsibilities of the distributor shall also change who,
concerning the terminology, the product documentation, as well as placing
in accordance with the new regulation, shall be required to comply the
the product on the market. A significant change is the introduction of the
compatibility of a given product with the provisions of the language of the
person responsible who can be both the producer as well as the importer,
country in which it will be marketed.
that is a natural or legal person who guarantees the safety of a marketed
In addition, the distributor is obliged to keep track of each and every lot of
product originating from a Member State of the European Union or from a
cosmetics. This means that distributors will need to keep an accurate record
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production | 19 of each lot number of the cosmetic product that ends up on the market. An
The patch test - the only plausible method detecting factors that induce
appropriate marking of the product (according to the provisions) is also an
contact dermatitis. The test is about applying pads moistened with the solution
important aspect for distributors.
of investigational product to back and reading after 48 and 72 hours. Tests
With the new regulation that took effect, the scope of the required
are carried out on a group of 30 people.
documentation of a given product and the process of its registration also change. The documentations of products, which are currently on the
Hypoallergenic patch test - carried out using the same method as the
market and will be there after 11 July 2013, ought to be updated and
pads-like evaluations. However, the group of probants consists of people
supplemented. The registration of products will take place in a pan-European
with a confirmed allergy, a spontaneous allergy. The test is intended to detect
portal - Cosmetic Product Notification Portal (CPNP) - which was founded
signs that would have a harmful i.e. allergic or toxic irritating effect in contact
on 12 January 2012.
with sensitive skin. RIPT test (Repeated Insult Patch Test) - conducted in order to assess whether the preparation causes contact allergy as a result of a repeated, multiple application on the skin. The test has two phases: I - induction and II - inducement. The test is often used for products intended for children or adults with allergic skin. Physical and chemical test - conducted in order to verify such parameters as: organoleptic evaluation (the appearance, colour, aroma, texture), pH, stability, density, viscosity, foam creation, dry denomination or others depending on the product. Stability test - conducted in order to verify the stability of the product in time and to determine the validity date and the storage conditions of the
The elements of the documentation
product. Stability evaluations should be carried out in the final packaging
Information on the Product
of the product, to confirm the compatibility of packaging and their stability.
• Information on the product should consist of: • the name and category of the cosmetic product,
Microbiological test - carried out for each and every lot number of the
• the qualitative and quantitative formulation,
product and are to confirm the cleanness of the product in terms of presence
• the technological process,
of fungi, mildew and other microorganisms which might have a harmful effect
• the characteristics of the finished materials,
on human health. During the test one ought to assign the total number of
• the presence of substances in the nanonuclear or CMR form,
mesophilic and oxidative microbes, Staphylococcus ureus, Pseudomonas
• -the data relating to the packaging,
aeruginosa and Candida albicans. The given tests ensure the safety of the
• the place of the documents’ storage (product dossier),
product during its application.
• the contents of the labels and marketing materials, • the contact information and contact information of all people responsible
Challenge test - conducted in accordance with European pharmacopoeias,
(production, confection, quality control, the person responsible)
using Koko-Test method or ISO/WD 11930 standard which aim at confirming
• the place of the production - the address of the establishment.
safety of the product despite possessing preservatives. The test is extremely important to guarantee any recurrent infections which might be present as
The product’s research:
a result of the contact of the product with the air or from the user (e.g. dirty
The safety assessment – it is the evaluation of formulation components
fingers). A cosmetic product is subjected to infections by the following test
based on the characteristics of toxicological and chemical structure of
strains: Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans,
components and the evaluation of the degree for contact of these substances
Aspergillus brasiliensis, additionally, Escherichia coli or Burkholderia cepacia.
with the human body. It is a detailed analysis of toxicological data for particular components of the cosmetic product and the results of tests of the finished
Application evaluation - conducted in order to confirm a specific activity
product. The evaluation consists of numerous parts:
of cosmetics. Tests are conducted on a group of at least 30 people selecting
• the evaluation of the product composition with the provisions of the law,
probants individually on account of the characteristics and the intended of
• the toxicological evaluation of the cosmetic ingredients,
the product in such a way that activity declarations are confirmed. During the
• the challenge evaluation or exposure evaluation,
test tolerability of the skin on the product at place of application and usability
• the risk evaluation for cosmetic ingredients,
of a product are estimated. The test is carried out with an assistance of a
• the findings evaluation of the finished cosmetic product: primarily
dermatologist; however, the results are a subjective assessment of the product
microbiological cleanness and dermatological features, • the report of the safety evaluation of cosmetics.
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being tested by the probants. The tests might be accompanied by an additional specialist, e.g. a gynaecologist, an optician or an allergologist by profession.
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20 | production The apparatus evaluations - tests which are additions to application
by the sun. All this allows you to see the effects of activities - smoothing
tests. They are carried out using testing equipment aiming at confirming
colour improvement after laser treatments, peelings, creams. The device
product activity. They are carried out in controlling conditions - air-conditioned
measures the concentration of melanin and hemoglobin for a thorough
rooms at the temperature of 22°C and relative humidity of the air 40-60% on
analysis of skin pigmentation. It also allows you to examine the length,
a group of people with an assistance of a doctor. Out of numerous devices
width and depth of wrinkles. VisioFaceQuick and Miravex Antera 3D™
available on the market, one may encounter the following ones:
apparatus measure the following parameters: the size and depth of
• Courage&Khazaka apparatus - the device is designed to analyze and
wrinkles, colour (erythema and hyperchromia), smoothening, level
assess the skin condition by determining the average result of changes of
of pores, UV. The results are prepared in the form of graphs, tables,
various parameters during the test. Probants are outlined with 2 or 4 fields of
descriptions, photographs.
size 2 x 2 cm on their face or arms on which a separately evaluated product
• Thermographic evaluation - the study aims at thermal skin evaluation
is applied. Measurements are done before testing, after the application of the
providing a blood supply for the subcutaneous tissue. They are often
preparation and in the designated dates. During one test the measurements
used to study the severity of cellulite and its treatment effects.
obtained from each field are summed up and are divided by two or four indicating the average outcome. Courage&Khazaka apparatus measures the
UV evaluations - the main purpose of the evaluation is to verify the
following parameters: moisturizing, TEWL, sebum, pH, pigmentation (erythema
UVA and UVB factor that ensure protection against radiation. The test is
and hyperchromia), temperature and flexibility. The results are prepared in the
performed on a group of at least 30 people, taking into account probants’
form of the graphs, tables, descriptions.
phototype, it examines the effectiveness of the product formulation used in
• VisioFaceQuick apparatus - the device is designed to illustrate the
the solar filter. Tests are performed by dermatologists using two methods:
analysis and evaluation of skin. Probants have photographs taken in
UV ratio tests by means of in vivo method, according to COLIPA (Guideline
the device before the application and at specified time periods after the
2007), BOOTS (2008 revision) or FDA guidelines and studies of UV factors
application. The photographs are evaluated in the programme attached to
by means of in vitro method - research methodology is based on COLIPA
the device. After determining the regions studied, the program compares
procedures and FDA standard.
the assumed parameters and prepares a report. (smoothening, wrinkles,
Using in vivo method one can perform:
pores, colour - delta T, delta E)
• UVB – SPF test
• Miravex Antera 3D™ apparatus - the device is designed to analyse
• UVA - UVA/UVB test
and evaluate skin. The results are prepared in 2D and 3D images
• photostability test
and by spectral analysis of skin. A quick scan shows a skin colour, its
• water resistance test
roughness, the depth of wrinkles, the extent to which skin is damaged
• photoallergy and phototoxicity test (Photo Patch Tests)
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production | 21 The in-vitro method makes it possible to perform the following tests: • UVB - SPF (in-vitro) test • UVA-PPD test
CPNP registration CPNP is already running and one can register products. Both the producers and the importers exporting products from outside the European Union are obliged to register the products. Registration is done electronically.
The In vitro method is used very frequently, even at the stages of the
It easies and unifies the procedures in the EU Member States. The manufacturer,
product’s formula as this method allows you to determine the critical wave
who exports products to other countries in the Union, shall notify their products
that facilities verification of the filters used.
once only. For this purpose, one ought to prepare such information as: • the name and category of a cosmetic product,
Water-repellency test - a test to confirm the effectiveness of UV filters after two 20-minute water baths. The test is conducted by dermatologists
• the address of keeping the documents (product dossier) ensuring a substance’s safety,
in controlled conditions, according to the COLIPA (Guideline 2007), Boots
• the substance existing in a nanonuclear or CMR form,
(2008 revision) or FDA guidelines. The study involves at least 30 people.
• the foreseeable routes of exposure, • the contact data and the people responsible,
Photostability test – the study to prove the stability of the product during
• the country of origin in the case of the imports from outside the EU,
its exposure to UV radiation. The study aims to determine that the SPF factor
• the Member State of the product being first marketed,
does not change under the influence of sunlight. The test is conducted by
• the photograph of a product,
dermatologists in controlled conditions according to the COLIPA (Guideline
• the framework formula.
2007), BOOTS (2008 revision) or FDA guidelines. The study involves at least 30 people.
The regulation no 1223/2009/WE also imposes a need on people responsible to update the documentation of the product after it had been marketed. This means
Photoallergy and phototoxicity test - the studies that are intended
that, if additional tests were done or one have access to scientific publications,
to exclude any alterations of an allergic or toxic type after applying the
product dossier must be updated. Another requirement is connected with keeping
product and, then, being exposed to UV radiation. The test is conducted
the documentation of the product for 10 years after the last batch of the product was
under controlled conditions according to the COLIPA (Guideline 2007),
entered on the market. The required scope and contents of safety assessment is
Boots (2008 revision) or FDA guidelines. The study involves at least 30
being extended which requires manufacturers or Safety Assessors conducting the
people.
assessment to access constantly toxicology updated databases.
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production 22 | production
Stability testing of cosmetic products Part 1 Irena Ozga Cosmetosphera
Cosmetic companies nowadays, in order to survive and to be competitive, must master the process of effective launching of cosmetic products on the market. Products are becoming more and more innovative, full of new and not sufficiently tested raw materials that are to be carriers of many marketing claims for products.
Time for testing is limited. What matters is the speed of implementation on
What should we do to completely make sure that the product will be
the market. Although time is limited, still market expects products of high
stable for a specific period of time at a given temperature? It should be
quality during their shelf life and during their usage.
tested for this specific period of time at a temperature that is of interest
Therefore, R & D laboratories as well as quality control laboratories test
to us. Such a test would give us full information about the stability
cosmetics in order to ensure product quality and in order to predict their
or rather instability of our product. However, as we have mentioned
behavior within time. There are numerous tests available. Amongst those,
before the company’s competitiveness requires a rapid response
the ones that should be carried out are the following:
to market and testing for such a long period of time is not possible.
• stability tests – designed to predict the behavior of cosmetic bulk within
Therefore, as an alternative, stability testing is applicable, which will
time, • compatibility testing – determining the interactions between the cosmetic bulk and cosmetic packaging • challenge tests – ensuring microbiological stability of the product within time.
shorten time and give us a view on potential changes, which can occur to the product. Note that products invariable within time do not exist. Product will always undergo some changes, it is only the mater of the environmental conditions and time when those changes will become visible. Each product will be subjected to a change within time. Type of change will depend on the type
The goal of this article is to highlight some issues of stability testing of
of product. Other changes can be expected for shampoos and detergent
cosmetic products. This is a very vast subject and leaves many questions
based products, emulsions will experience other changes, yet others will
about the application and methodology. I hope that at least some of them
occur for fragrances and color cosmetics. The subject of changes will be
will be provided with answers.
also addressed later on in this article.
Why do we need stability testing?
Legal requirements
Stability testing is the product evaluation, in particular cosmetic bulk,
Stability tests have always been important from quality and safety point of view.
designed to predict its ability to maintain the original parameters within time.
Legislative changes that are ongoing, I mean the Regulation of the European
It is particularly important to ensure proper behavior during the shelf life of
Parliament and Council No. 1223/2009 of 30 November 2009 on cosmetic
the product and during its normal usage in the final package. PAO symbol
product, in Annex 1, Cosmetic Product Safety Report „refers to stability
(open jar) is determined based on the results of stability tests.
testing of cosmetic product.
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23
Part A section 2. of ‘Safety Report ‘refers to the physical / chemical properties and stability of the cosmetic product.
Product specification Before starting stability testing the person in charge should determine the
Regulation requests the following information to be included in the Report:
optimum specification of the product as well as parameters critical for the product.
• ‚The stability of the cosmetics product under reasonably foreseeable
The parameters will vary depending on the type of product. The chosen
storage conditions’.
parameters will be monitored and reported in stability report for the product.
• Stability test report should therefore be part of a cosmetic product safety
Most common parameters usually included in specification are the following: • changes color, odor, appearance of the product, a good indicator
report.
of stability for emulsions will be microscopic view Moreover, stability testing should d be planned beforehand as well as
• changes of pH
it should be carefully foreseen in the process of implementing product on
• changes viscosity
the market.
• loss of water
Fundamentals of stability tests
• changes in chemical parameters such as the content of active ingredients, which may break down.
The basis of accelerated tests is the influence of elevated temperature, which helps to accelerate and quickly determine the
Critical parameters should be monitored during stability tests.
effect of the changes which the product may undergo within time. The van Hoff’s rule says that for every temperature rise of 10 degrees Celsius
When to stability test?
rate of reaction doubles.
The question when to test product is always tricky one to be answered. To ensure the highest quality testing would be advisable to carry out
In practice, it is assumed that the sample stored at 45oC for 8-12 weeks,
stability testing on the following stages of the process:
showing no sign of change is an indicator of the stability of the bulk for
• stage of lab development -test on accepted prototype formulation
2 years at room temperature.
• scale-up-transfer from beaker to an intermediate mixing vessel • pilot batch- first bulk manufactured on production vessel
Temperature range of stability testing may vary depending on the product
• first batches of the finished product
and company procedures. More on this topic will be written in the section
• change of supplier of raw material or raw material grade
on testing methods.
• changes of packaging component, its type or composition • significant changes of process parameters, transfer to another vessel
Testing at elevated temperatures has many advantages as it allows us to
or change of the batch size.
significantly reduce the time, but unfortunately it is not flawless. Other changes can occur at elevated temperatures than at room temperature. Very often,
This is the end of our reflections for today. In the second part of this article
the stability of perfumes, dyes or active ingredients at higher temperatures
we will describe the testing methods and types of changes that can occur to
can be quite different from the changes that will occur at room temperature.
specific groups of products.
Basically it can be assumed that the testing at elevated temperature is a good indicator of instability, but does not determine stability.
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Saying goodbye, I wish you all very successful, highly innovative and very stable cosmetic products!
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24 | production
Evaluation of disinfectants effectiveness in cosmetic industry – testing methods and necessity of testing Ewelina Bartosz Kierownik Jakości
What are disinfectants and how do they work? Disinfectants serve chemical disinfection that is reduction of the bacterial
• method of use (time of contact, concentration of the preparation used, dilution, additional flushing),
count on the surfaces of facilities, tools and devices. The biocidal activity of
• scope of operation (bacteria, fungi, viruses, etc.)
disinfectants eliminates undesired microorganisms from the environment and
• application area.
prevents them from spreading. The manufacturer applying the disinfectants (the user) should determine The disinfectants activity depends on the:
the:
• chemical composition of the product,
• applicable product concentration applied under actual application
• reactivity of active substances,
conditions,
• product stability,
• contact time effective in the given manufacturing environment,
• concentration applied,
• effectiveness in case of the environmental strains,
• active time of the preparation,
• determine the usable life of the solution applied.
• level of contamination, • temperature, • type of surface disinfected.
Areas of disinfectants application The PN-EN 14885:2006 standard is the fundamental standard for testing disinfectants. It contains the collection of Polish and European standards
The disinfectant manufacturer should indicate the:
according to which the product effectiveness in a given area of application
• product type and intended use (e.g. disinfection of surfaces, tools, hygienic
is tested.
washing of hands, etc.),
The following disinfectants application areas are identified: • medical – encompassing preparations applied for disinfection of surfaces, tools and devices at health service facilities, • veterinary – encompassing preparations applied for disinfection at veterinary facilities as well as those applied in animal breeding, rearing, feeding, production and trade, • food, industrial, household and institutional - encompassing preparations applied for disinfection in processing, distribution and trade of food products of animal and vegetable origin, public utility facilities as well as cosmetic, pharmaceutical, biotechnology, packages and other industries.
Testing of disinfectant products Effectiveness of disinfectants is verified by conducting tests according to the standard applicable to the given area of application. Biocidal activity of the preparation is evaluated using test microorganisms characteristic for the given area. Use of certified test strains originating from known and acknowledged collections such as the ATCC for the test is very important.
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25 Tests are conducted at a laboratory, which allows assuring compatible and
PN-EN 1276 and PN-EN 1650 standards describe suspension-based
repeatable conditions, controlled parameters during testing and evaluation by
methods of bactericidal and fungicidal activity testing for chemical
methods simulating conditions applied in practical applications.
disinfectants. Application of the above-indicated methods allows determining
According to the European Commission guidelines, disinfectants should be evaluated during two consecutive phases:
biocidal properties of products applied in dilution at concentrations of 80% or lower only.
• phase 1 tests – quantitative suspension based testing methods aiming at determination whether the product has bactericidal, fungicidal or
Testing method according to the PN-EN 1276 and PN-EN 1650 standards
sporicidal properties without considering the conditions defined for the
Testing method principle
intended application.
The suspension based test method involves addition of the tested
• phase 2 tests involve two stages:
suspension of bacteria or fungi (in the contaminating substance solution)
• phase 2, stage 1 – quantitative suspension based tests corresponding to
to the prepared disinfectant solution. The mixture is maintained at 20°C for
actual conditions of application according to the intended use to determine
the contact time of 5 minutes (bacteria) or 15 minutes (fungi) and after that
whether the product has bactericidal, fungicidal, bacillocidal, sporicidal
time the disinfectant activity is neutralised. Next the mixture is inoculated on
or virucidal effect,
plates and incubated under conditions appropriate for a given microorganism.
• phase 2, stage 2 – quantitative laboratory test simulating practical conditions, e.g. tests on surfaces, tools, washing hands, rubbing into hands, to determine whether the product has bactericidal, fungicidal, bacillocidal, sporicidal or virucidal effect.
Following incubation, colonies that developed are counted and the bacterial or fungal count is obtained. The biocidal activity of the disinfectant is evaluated on the base of the number of bacteria or fungi reduction level.
Phase 1 tests The quantitative suspension method is the method for testing the biocidal activity of the disinfectant in phase 1. The test is conducted according to the PN-EN 1040: 2006 standard verifying the bactericidal activity and according to the PN-EN 1275:2006 standard verifying the fungicidal activity. Testing according to the above-indicated standards is treated as the so-called initial testing. The test provides the information on whether the disinfectant possesses the biocidal properties only while it does not determine the applicable concentration of it. Conducting phase 2 tests is necessary to determine the applicable concentration of the disinfectant. Phase 2 tests Phase 2 tests encompass two stages: • stage 1 with application of suspension methods, • stage 2 with application of the carriers (i.e. surfaces). The suspension method involves dilution of the product and as a consequence it cannot be used in case of preparations declared as products for direct application. In case of testing undiluted products the carrier method is applied. The choice of the standard according to which the effectiveness
Test strains
of the given disinfectant should be tested depends on the product
The following test strains are considered in the tests:
application area, test type (phase, stage), product concentration
• bacteria: Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia
(product applied in dilution or undiluted) as well as the declared range
coli, Enterococcus hirae.
of biocidal activity.
• fungi: Candida albicans and Aspergillus brasiliensis.
Testing of disinfectants in cosmetic industry
Disinfectant effectiveness evaluation
Effectiveness evaluation in case of disinfectants intended for application
• bactericidal activity: the product is considered effective if 5 minutes
in the cosmetic industry is conducted according to the following standards:
contact results in the reduction of viable bacteria by at least 5 log values.
• PN-EN 1276,
• disinfectant fungicidal activity: the product is considered effective if 15
• PN-EN 1650,
minutes contact results in the reduction of viable fungi by at least 4 log
• PN-EN 13697.
values.
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26 | production Testing method according to the PN-EN 13697 Testing a product according to that standard the bactericidal and fungicidal
• Fungicidal activity: the product is considered effective if 15 minutes contact results in the reduction of viable fungi by at least 103–fold.
activity of the undiluted (ready to use) preparation can be determined. In testing disinfectants we can also use other strains of microorganisms Testing method principle The test method involves inoculation of the surface with a suspension of bacteria or fungi in the contaminating substance solution and subjecting it to
(e.g. strains present in the production environment), different exposure time and temperature to take into account application of that disinfectant under specific production conditions.
drying. After drying the tested disinfectant is spread over the surface and left for the predetermined contact time. After the predetermined time of exposure
Recommendations for manufacturers of cosmetics
the surface is transferred into the neutralising solution to stop the activity of
Applying disinfectants one should be sure that the product applied is
the disinfectant. Next the mix is inoculated on plates and incubated under
effective in the preparation application location. That is why laboratory tests
conditions appropriate for the given microorganism. Following the incubation
of disinfectants thanks to which we may prove that the preparations applied
time the colonies that developed are counted and the count of bacteria or
give the desired effects are so important.
fungi is taken. The number of viable bacteria or fungi from the test surface is determined quantitatively.
Manufacturers applying disinfectants should conduct test to: • verify the effectiveness of the product in the concentration used that is applied for disinfection of surfaces in production facilities, devices and auxiliary equipment at the production facility. This is particularly important in case of product effectiveness against environmental strains as the disinfectant manufacturer is required to conduct the tests using the standard strains only without determining the range of concentrations effective in case of strains that could be present in the production environment, • determine the exposure time that will be applied under our conditions because the exposure time declared by the disinfectant manufacturer may be ineffective against environmental strains that could be present in the production facility and the contamination levels of surfaces for disinfection of which the given disinfectant is applied, • verify whether the preparation that is used for cleaning and disinfection of surfaces in effective in case of the environmental strains that might threaten maintaining the adequate level of production hygiene; as a consequence, tests should be conducted not only on test strains considered in the standard but also on strains recovered from the production environment or product itself, • verify the permitted storage time of solutions applied to prove that the
The second surface with dried suspension of the strain tested is exposed to water and the count of microorganisms on the test surface is taken. Next,
disinfectant applied possesses the biocidal properties across the entire time of its application.
on the base of the difference between the number of bacteria or fungi from the test with water and the number of microorganisms recovered from product test is used to compute the capacity of the product to reduce the number of viable microorganisms.
Conclusion Prior to registration with the Registration Body, the disinfectant manufacturer must conduct tests of compliance with the applicable standards to confirm that the preparation possesses the declared biocidal
Test strains The following test strains are considered in the tests: • bacteria: Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Enterococcus hirae. • fungi: Candida albicans and Aspergillus brasiliensis.
characteristics. The product user is recommended, on the other hand to conduct tests of the disinfectants applied to confirm that the given preparation is effective under his production conditions. Thanks to such tests it is possible to verify whether products applied in the procedures of cleaning and disinfection show biocidal activity in relation
Disinfectant effectiveness evaluation
to the environmental strains, whether the concentration of solutions used
• Bactericidal activity: the product is considered effective if 5 minutes contact
and exposure times are appropriate and whether the used solutions storage
results in the reduction of viable bacteria by at least by at least 104–fold.
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times influence the activity of the preparation.
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production | 27
In vitro alternative methods of eye irritation tests
Part 1
Joanna Organiściak-Płachta
Salt City Pharma Center
One component in the safety assessment of many types of products is the evaluation of their potential to cause eye irritation or corrosion.
Until recently, the Draize Rabbit Eye Irritation Test, developed in 1944,
In vitro tests had generally been designed to model only one or just a few
had been the standard method for evaluating the ocular irritation/corrosion
ocular tissues, not the whole eye. This is very helpful in obtaining more detailed
potential of a substance.
mechanistic information about the process of eye irritation. However, it then
However, the Draize Rabbit Eye Test has been increasingly criticised due
potentially force us to replace a single animal test with multiple in vitro tests.
to its lack of reproducibility, its overestimation of human responses, and the
This is not necessarily undesirable. Using several in vitro assays accurately
cruelty to animals that it involves.
depicting the mechanical aspects of eye damage, probably will allow us to
The recently implemented 7th Amendment to the EU Cosmetics Directive
learn more about the actual risk of the use of chemicals by humans.
and the EU REACH legislation have heightened the need for in vitro ocular
According to ECVAM [European Centre for the Validation of Alternative
test methods. Changes in legislation and increasing pressure from animal
Methods] in the case of eye irritation it is generally accepted that, in the
rights organizations gradually eliminate the use of methods for testing of
foreseeable future, no single in vitro eye irritation test will be able to replace the
cosmetics ingredients on animals.
Draize eye test to predict across the full range of irritation for different chemical
The following systems can be used as partial or full replacements of animals in toxicology experiments: • in vitro methods: cell cultures, reconstructed tissues, co-culture systems, • ex vivo methods: isolated animal tissues and organs, • in silico methods: computer simulations and mathematical models, QSAR’s
classes. However, strategic combinations of several alternative test methods within a (tiered) testing strategy may be able to replace the Draize eye test.
Definition Eye irritation is defined as the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are
It would be perfect to replace traditional animal-based test methods by
fully reversible within 21 days of application.
in vitro alternative method, what will allow to keep the testing regime simple
Eye corrosion (serious eye damage) is defined as the production of tissue
and economical, obviously assuming that new in vitro method will provide the
damage in the eye, or serious physical decay of vision, following application of
data of equal or better quality than the traditional in vivo test.
a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.
It’s not that simple.
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28 | production
wound or by the actual replacement of damaged tissue through new cell division. In contrast, the endothelium is generally not capable of self-healing. Therefore, if these cells suffer cytotoxic damage there can be significant consequences, e.g., permanent blindness.
Eye In interpreting the results from any toxicologic study, there must be some basic knowledge of the organ system being studied - at the very least an
It is this relationship between the induction of cellular damage and resulting ocular irritation or other injury that is the basis for in vitro ocular irritation methods.
understanding of its morphology, cellular constituents, and normal function
Another delicate tissue of the eye is the conjunctiva, the non
- that allows one to determine whether an injury has occured and what the
keratinized squamous epithelium that lines the inner surfaces of the
consequences of that injury are.
eyelids and much of the external surface of the ocular globe (it is
The eye is a very intricate organ made up of multiple tissues, each of which responds differently to injury. Perhaps the most important tissue is the cornea. The normally transparent cornea allows light to freely enter the eye and eventually be focused on the
continuous with the cornea). The conjunctiva is highly vascularized and may become quite inflamed after exposure to irritating materials. Mildly irritating chemicals or other products often cause conjunctivitis without any associated corneal damage.
retina. If the cornea becomes cloudy (opaque) - as can happen after accidental
A third important ocular tissue is the iris (the colored part of the
exposure to strongly irritating chemicals - light can no longer pass easily into
eye), which by constricting or dilating, controls the amount of light that
the eye and vision becomes impaired or even completely blocked. Although
enters the eye and is eventually focused on the retina. The iris lies under
the eyelids offer the cornea some protection, it is still very susceptible to injury.
the cornea within the aqueous humor. In some cases foreign materials
About 80 % of the cornea’s structure is the stroma - a regular array of
penetrate completely through the cornea and interact with the iris. The
macromolecules through which light can easily pass as a consequence of
iris may then become very inflamed and may lose its ability to react to
the stroma’s high degree of order and exact level of hydration.
light, seriously damaging the ability to see.
Maintenance of this very important hydration level (75-80% water) is the responsibility of two active cell layers: • a single-cell-thick endothelium covering the inside surface of the cornea and
Observations of the degree of injury to each of these tissues in the animal model are incorporated as part of the scoring system of most common eye irritation protocols.
• a much thicker epithelium that covers the outside surface of the cornea Generally the process of substance testing consists of several steps These cell layers work together to keep additional water from entering the cornea, which would result in swelling and opacity. The epithelium also has a second function of providing a physical barrier against the entry of foreign materials. If the epithelium is injured, corneal opacity can result. However minor opacities can often be reversed because the epithelium can recover itself either by movement of surrounding cells to cover the
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• First - the maximum potential hazard of the ingredient or formulation to the ocular tissue is determined. • Second - the actual use of the product is considered, estimating the probability that it may inadvertently enter the eye. • Third - a final safety assessment takes into account benefits, risks, and the impact of the instructions for use that generally accompany the product.
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Although the entire process is important, it is the first stage of this process-
Historically, the albino rabbit has been the animal of choice for testing
generally termed hazard identification-and the development of improved in
potential eye irritants, because of size of the eyes, which make it easy to
vitro systems to detect such hazards that are important.
observe damage and size of conjunctival sac (accentuated by loose lids) that easily accepts test material.
Draize test
However, because of several striking differences, the rabbit is far from
In Draize test, chemicals, mixtures, and formulations are introduced
the perfect model for humans.
directly into the conjunctival sac of the rabbit eye. The other eye serving as
The anatomy and biochemistry of the rabbit eye are not equivalent to
the negative control, and the response of the animals is monitored using a
those of the human eye.
standardized scoring system for injury to the cornea, conjunctiva, and iris.
Here are the differences:
Ocular responses are scored at 1, 24, 48, and 72 hours. The animals are
• third eyelid, which moves laterally across the eye, likely causing removal
observed until the full magnitude and reversibility of the ocular injury can be evaluated—for up to 21 days.
of many test material, what differ from humans. • conjunctival sac – much larger than in humans, what means more material
The topical application of chemicals can cause irritation and/or corneal
can be placed in the rabbit’s eye than would be likely to ever get into human
damage in several ways, including:
eye during an accidental exposure. [100 ml of liquid or 100 mg of a solid]
• lysis of membranes (e.g. by surfactants, organic solvents);
• cornea – rabbit cornea is much thinner than humans
• denaturation of proteins (e.g. by surfactants, organic solvents, alkalis
• production of tears - the rabbit produces fewer tears • blink frequency
and acids); • saponification of lipids (e.g. by alkalis); and
• ocular surface area
• alkylation or other covalent interactions with macromolecules (e.g. by bleaches, peroxides)
For these and other reasons the rabbit is generally considered an overly sensitive model for humans, what may be considered a positive aspect,
Reversibility of the ocular injury is an important component in the classification of a substance as an eye irritant versus an eye corrosive. Known since 1944 Draize Eye Test Rabbit Irritation uses a complex
because it adds a safety margin to the risk management, however it presents the problem of inappropriate hazard assessment and suggests that a more predictive model would be beneficial.
scoring system that reflects the degree of damage to the three major tissues of the eye. Also, the reversibility and the severity of the effects are evaluated. The modified Draize Test method is Low Volume Eye Test (LVET) method,
References 1. “A Summary Report of the COLIPA International Study on Alternatives to the
which uses one-tenth of the material normally applied to the rabbit eye. LVET is reported to be better predict the response of human eyes and to be less
Draize Rabbit Eye Irritation Test.” Toxicology in vitro 1 I (1997) 141-179 2. “Evaluation of the EpiOcularTM Tissue Model as an Alternative to the Draize
hazardous to the animal.
Eye Irritation Test” M. Stern, M. Klausner, R. Alvarado, K. Renskers and M.
The retrospective validation study of the refinement/reduction Low Volume
Dickens.
Eye Test (LVET) method for the use domain of household detergents and
3. “Development of the EpiOcular™ Eye Irritation Test for Hazard Identification
cleaning products as well as their main ingredient classes took place between
and Labelling of Eye Irritating Chemicals in Response to the Requirements
2006 and 2009.
of the EU
After peer review, the LVET was not recommended for prospective use, i.e. to generate new data but it was recommended that existing LVET data of the limited use domain of household detergents and cleaning products as well
Cosmetics Directive and REACH Legislation” Yulia Kaluzhny, Helena Kandárová, Patrick Hayden, Joseph Kubilus, Laurence d’ArgembeauThornton1 and Mitchell Klausner.
as their main ingredient classes may be used for purposes of classification
4. “Update on the COLIPA research programme for development of in vitro
and labeling decisions. Moreover, it was recommended that existing LVET
alternative methods for eye irritation” Pauline McNamee1 (Chairperson), Lieve
data of this limited use domain may be used as supplementary data for future
Declercq, Ann De Smedt, Bart De Wever, Claudine Faller, John Harbel, Penny
validation studies. No additional testing should be however performed to
Jones, Monique Marrec-Fairley, Wolfgang Pape, Uwe Pfannenbecker, Klaus
further develop or validate the LVET test (ESAC, 2009).
Schroeder, Magalie Tailhardat, Christine Van den Berghe and Freddy Van Goethem.
Why not rabbit
5. “In vitro Alternatives for Ocular Irritation” Rodger D. Curren and John W. Harbell
Mentioned above Draize Eye Test Rabbit Irritation uses a complex scoring system that reflects the degree of damage to the three major tissues of the eye. Aside from the obvious ethical reasons, requiring the discontinuation of
6. ALLTOX - http://alttox.org/ 7. COLIPA - http://www.colipa.eu/ 8. MatTek web - http://www.mattek.com/pages/abstracts/searchresults/
cosmetics testing on animals, the quality and accuracy of the results obtained
9. IIVS - http://www.iivs.org/
by this method is also questionable.
10. TSAR - http://tsar.jrc.ec.europa.eu/
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30 | production
How to reduce cavitation in homogenizers of a vacuum processing unit Oliver Fischer
Vacuum Processing units are used to produce liquid or semi liquid products like emulsions or dispersions under controlled and repeatable conditions. The key tool to create a fine dispersed product in such a unit is the external homogenizer with a Rotor / Stator system.
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• Reduction of the temperature in the system • Increase of pressure in the system • Increase of the suction head • Choosing a big flow cross section in front of pump • Increase of pressure in front of the homogenizer with an inducer • Alignment of the fluid flow in front of the pump Due to specific process parameters for the production of emulsions or dispersions some of these options cannot be used when designing a homogenizer for a vacuum processing unit. An aerodynamic design of the rotor / stator system for example is not possible because it is necessary to have high shear forces in production. Also the process parameters like under pressure or high temperatures are given from the production process. Homogenizers with a Rotor / Stator system are working in principle like centrifugal pumps. They have fast rotating tools which create a pressure difference from the entrance to the outlet of the housing and so have the possibility to create their own pump capacity. The geometry of the Rotor / Stator is optimized to create a high shear force in the medium which will flow through the homogenizer. Because of this geometry, which helps to increase the shear to the product, there is a potential risk of cavitation in a homogenizer. The typical indications of cavitation in the production process are very loud and noisy production units, vibrations, a reduced pump capacity and wear at the rotating parts.
What is cavitation Cavitation is well known in all kind of pumps or systems which have their own pumping capacity like Rotor / Stator systems. If there is cavitation in such a system, the pressure at the suction side is below the vapor pressure of the medium. Below this pressure gas bubbles are built. These gas bubbles implode very fast when they pass the lower pressure area in front, into the higher pressure area after the pump. The reason
Therefore zoatec has designed their homogenizers with a big flow
is that the system pressure rises after the rotor / stator and so the gas
cross section at the inlet. There is a free flow into the homogenizer.
starts to condensate immediately. These implosions generate local high
The flow direction of the liquid is unique. The product flows away from the
forces which can demolish the rotating parts. The risk of cavitation will
mechanical seal into a conical reductions piece. In this reduction peace
increase if there are process parameters in the production process which
a special designed inducer is positioned. These three measures help to
allow the medium to evaporate more easily. Such process parameters
align the flow into the homogenizer and to increase the pressure in front of
are low pressure (vacuum) in the complete production vessel or a high
the homogenizer tools. In this way there is a constant pressure increasing
process temperature.
from the inlet to the outlet of the system. The risk of cavitation during the
Exactly these two parameters are very often used when pharmaceutical or cosmetics emulsions are produced in a vacuum processing unit.
production process is minimized. In addition to these design features all motors are equipped with a frequency converter to have a variable rotation speed of the homogenizer. The combination of all these arrangements
What can be done against cavitation in a homogenizer?
helps to have a stable production process in a vacuum processing unit without having the high risk of cavitation in the homogenizer.
In the theory of pump design there are some options given to prevent a system from cavitation. Some of these are: [1]
List of references:
• Reduction of rotation speed of the rotating parts
[1] Walter Wagner; Kreiselpumpen und Kreiselpumpenanlagen; Vogel
• Special design of pump impeller with an aerodynamic geometry
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Fachbuch 2004.
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production 32 | produkcja production
Cosmetic Product Information File – European Requirements
Agnieszka Nnolim
Toxicology Consultant (Delphic HSE)
The Regulation (EC) No 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products, known as Cosmetics Regulation or Regulation, was published in the Official Journal of the European Union on 22 December 2009. It is important to highlight the fact that the first Cosmetic Law, Council Directive 76/768/EEC governing composition, labelling and packaging of cosmetic product, was implemented on 27 July 1976, this was approximately 36 years ago. The Regulation has replaced Directive and its subsequent amendments and will be effective in full on 11 July 2013.
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The Colipa guidance published on 15 December 2011 explicates meaning with regards to Product Information File giving a clear picture of the
Information required – Product Information File (Table 1)
Responsibilities. With the reference to the Colipa document crucial points
• A Description of the Cosmetic Product (Article 11.2.a / Product Information File)
have been outlined in this review.
• C osmetic Product Safety Report (CPSR)(Article 11.2.b / Product Information File)
Responsibilities – Product Information File The responsibilities in the area of the Product Information File requirement
• Method of Manufacture and a Statement of GMP compliance (Article 11.2.c / Product Information File) • Proof of the Effect Claimed for the product (Article 11.2.d / Product
are within: • the Responsible person (manufacture or supplier or a designated person) • the Safety assessor
Information File) • Data on Animal Testing Performed (Article 11.2.e / Product Information File)
• the Distributor “The European Commission recommends that companies be-
Responsible person – Liability regarding the Product Information File
gin to revise existing product information as early as possible
• make sure that a cosmetic product placed on the EU market is safe for
further rework, it is also recommended that the Product
human health under normal or reasonably foreseeable conditions of use, • make sure that specific information on the product places on the market are maintained (Article 11 / Product Information File),
to ensure compliance with the new Regulation. To prevent Information File for new products be prepared according to the new requirements” (Colipa) The Product Information File for existing products needs to be revised
• m ake sure that the product placed on the market meets all new
and made accessible in its new structure from 11 July 2013. In addition, the
requirements, the responsible person should be prepared to demonstrate
Product Information File needs to be kept for 10 years after the last batch of
it upon request (Article 5.3 /Obligations of responsible persons),
the product is marketed within Europe.
• make sure that the Cosmetic Product Safety Assessment (CPSA) has been performed by a qualified and experience safety assessor, • make sure that the safety assessment as well as the data upon which it
Transitional provisions – Product Information File
is based as part of a Cosmetic Product Safety Report (CPSR) is kept in
Product Information File requirements set up in Article 11 of the Regulation
the Product Information File along with all updates in view of additional
will apply on 11 July 2013 (Article 40). For all products placed on the market
relevant information generated after placing the product on the market
before 11 July 2013 which already comply with the Product Information File
(Article 10.1(c) / Safety assessment),
and related requirements of the Regulation, the compliance with Article 7a
• make sure that the responsible person has a Product Information File
of the Cosmetics Directive does not apply (Article 39).
readily available in order to answer enquiries made by the competent
The cosmetic product may be notified under the new Regulation between
authority where the Product Information File is kept along with evidence
11 January 2012 and 10 July 2013, however the Product Information File does
proving that the product is in compliance with the Regulation.
not have to be compliant with Article 11 before 11 July 2013. Only cosmetic products placed on the market from 11 July 2013, must have their Product
Safety assessor – Liability regarding the Product Information File
Information Files in compliance with requirements of Article 11.
• assess the product against the safety and law before it is placed on the
Access to information for the public – some parts of the Product Information File
market, • gather all the necessary information to document the safety of the product
The notification (https://webgate.ec.europa.eu/cpnp) of the cosmetic
as outlined in the Cosmetics Product Safety Information and Assessment,
product, its registration and public access to the notification portal has been
• liaise with the Responsible Person to ensure that the gathered information
accessible from the 11th January 2012 from the following address https://
are kept up to date.
webgate.ec.europa.eu/aida/selfreg According to the Article 21 some of the information presents in the
Distributor – Liability regarding the Product Information File
Product Information File needs to be made accessible to the public as it
• liaise with the Responsible Person and the Competent Authorities to make
• Product name and Company name
highlights below;
sure that the product placed on the market complies with the Regulation
• Qualitative and Quantitative composition of the product
(Articles 6(3), 23 and 26) / Obligations of distributors, Communication of
• Data on undesirable effects and serious undesirable effects related to
serious undesirable effects, Non-compliance by distributors).
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the product
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34 | production
Table 1. Product Information File
The Description of the Cosmetic Product
Cosmetic Product Safety Report (CPSR)
A Description of the Method of Manufacturing
Cosmetic Product Safety Information (IPSI) o
Quantitative and Qualitative Composition
o
Physical and Chemical Characteristic, Stability Testing
o
Microbiological Quality
o
Impurities, Traces information about Packaging Compatibility
o
Normal and Reasonably Foreseeable use
o
Exposure to the Product
o
Exposure to the Substance
o
Toxicological Profile of the Substance
o
Undesirable Effects and Serious Undesirable Effects
o
Other Information on the Product
A Proof of the Effect Claimed for the Cosmetic Product
Data on any Animal Testing Performed
“undesirable effect” means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product
Cosmetic Product Safety Assessment (CPSA) o o o o
Assessment Conclusion Labelled Warnings and Instructions of Use Reasoning Assessor's Credential and Approval of CPSI
of products marketed is small it would be advised that the actual number of undesirable effects is provided.
((Article 2.1(o) / Definition). Undesirable effects may include irritant or allergic reactions that can affect the skin or eyes and other undesirable effects which should be specified.
Conclusion Good organisational and coordination skills will reassure the company to
”serious undesirable effect” means an undesirable effect which results
keep up with the best approach towards understanding of the significance of
in temporary or permanent functional incapacity, disability, hospitalisation,
the new Cosmetic Requirements. In the situation where the misinterpretation
congenital anomalies or an immediate vital risk or death (Article 2.1(p) /
or lack of attention in the communication processes occurs, the company
Definition). In order to keep consistency in the information providing to the
may encounter financial problems. The main priority for the companies is to
public, a value for the number of (serious) undesirable effects per million
apply the new Cosmetic Requirements from now on in order to avoid any
units placed on the European market should be calculated. If the number
commercial disappointment.
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raw materials | 35
Determination of liposome particles size by use of dynamic laser light scattering method MSc Alina Bazan Experimental station Organika Ltd
PhD Anita Przepi贸rkowska Technical University of Lodz, Institute of Polymer and Dye Technology
Size of particles is extremely important issue as it allows specification of dispersive properties of investigated substances and determine polydispersity index which informs us about stability of analyzed raw materials.
There are several measurement methods used to determine size of
using Photon Correlation Spectroscopy PCS also referred to as Dynamic
particles. Among them we can distinguish two categories of research
Light Scattering DLS鹿. This spectroscopy is used to measure size of particles
methods namely direct and indirect methods. In direct methods, the
in the range from few nanometers to few micrometers. Measurement
measurement is performed thanks to illustration of interaction between
of particle size is based on illumination of investigated dispersion with
radiation and investigated particles. In second group are indirect methods
a monochromatic, coherent light of specific frequency (laser light). Basic
and here we can classify all types of microscopy in which various types
measuring system is shown on figure 1.
of radiation are used (photons and electrons). Measurements of liquid
Operating principle of above instrument is based on laser (Fig.1), which
nanodyspersy including measurements of liposome size are performed
illuminates investigated sample which is a type of water suspension.
Lens
Laser
Sample
Videointercom
Primary beam quenching instrumentj
Scattered light
Coherence optics
Scattering angle Printer
Counting unit
Correlator
Detektor Detektor electronics
Control panel
Fig. 1. Schematic diagram of PCF device 2)
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36 | raw materials Radiation scattered by particles is recorded by detector which is positioned at 90 degrees relative to incident beam. Dispersed particles are in constant Brownian and thermal motions. Smaller particles have faster diffusion motions and scattered light fluctuates at higher rate³. Bigger particles diffuse slower which causes fluctuations at lower rate. Hence, changes in light intensity reaching detector carry information about size of dispersing particles which is fundamental for further analysis of those particles. The analyzer of particle size is device available of the market Zetasizer Nano Series S90. It analyzes particles in range from 0.6 nm to 6 µm. This device allows investigation of electro kinetic processes taking place in suspensions of very fine particles. Therefore it is applied in cosmetic and pharmaceutical industry at the stage of development of new recipes for final product. The subject of this paper are liposomes which were analyzed with Zetasizer Nano Series S90. Stability of liposomes depends on many factors including its structure and storage conditions. Measurement of particles size enables liposomes analysis and define their quality. By measuring size of particles we are able to conclude if product is stable over time and if liposome retains specific intended features guarantying highest quality of final product. Another issue is liposome penetration speed and permeation of active ingredients encapsulated in liposomes into target place in our skin. Liposomes that has smaller particles/Small size liposomes has shorter time of penetration to deeper skin layers. In cosmetic industry liposomes in range between 100 to 250 nm are used. Vesicles with diameter less than 100 nm can penetrate too deep into skin, even reaching bloodstream which is undesirable in cosmetic industry and can cause troublesome
cosmetic products. Thus particles size measurements are essential also in this aspect.
Methodology 20 µl of liposome in 1 ml of water making visually homogenous suspension without air bubbles was used in a single measurement. Parameters of particles size measurements performed with Zatasizer Nano Series S90 are shown in Table 1.
and negative effect for human health. This information is important and
Volume, %
relevant for next production step which is addition of liposomes to final
Size,nm Size, nm 100,8 100,6 100,1 Σ 100,5 nm
Liposome without preservatives
PdI 0,195 0,191 0,197 Σ 0,194
Fig. 2. Results of liposome particles size measurements
Parameter
Value
temperature
25
Solvent (water) viscosity
0.8872
Light refractive index (water)
1.33
Light refractive index (liposome)
1.37
Duration of measurement
20
Number of measurements
10
Number of repetitions per sample
3
Time of temperature stabilization of sample
5
Unit C
o
cP
s
min
Table 1 The list of parameters of particle size analysis of liposomes
Measurements of particles size were performed and polydispersity Volume, %
index was defined for liposome containing only natural ingredients. Sample was prepared by dilution of liposome in water MiliQ maintaining parameters shown in Table 1. Measurement was repeated three times according to Good Manufacturing Practice (GMP) principles. Size,nm Liposome without preservatives
Size, nm 100,7 100,9 100,6 Σ 100,7 nm
PdI 0,195 0,198 0,196 Σ 0,194
Fig. 3. Result of liposome particles size measurement after one month storage in room temperature
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Obtained results of investigations of particles size and polydispersity index are presented in figure 2. Analyzing size of liposome particles we can conclude based on results presented on Fig.2 that sample has very good size of particles. This liposome can be applied in cosmetic formulation thanks to its low polydispersity index 0.194. The smaller value of polydispersity index the better stability of
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liposomes in time. In second part of the study, sample was analyzed after one month storage at temperature of 25°C. After this time the size of liposome was assessed again. Figure 3 shows small changes in particles size which proves that liposome is very stable in time and can be incorporated in final cosmetic compositions. Particles size is one of many parameters which are necessary to assess quality of cosmetic raw materials. Obtaining good products of high quality is an effect of many years of technologists work and numerous investigations which would confirm that raw ingredients used in final cosmetic products
Importer of cosmetic packaging
are safe and ready to use.
Packaging for white and color cosmetics
Summary
Various materials
In cosmetic industry measurements of particles size is very important parameter which allows precise assessment of raw material features at the stage of new cosmetic formula creation. This is just a selected example of liposome analysis using PCS method which surely can be successfully used for other ingredients at the stage of their control before incorporating them
Any possibility of decorations and ornaments We have products on sale of warehouse and imported to the individual order
in further production.
References 1. 2. 3.
www.malvern.com A. Kozubek, „Introduction to liposome technology”, WUW, Wrocław 2004. PN-ISO 13321 Granulometric analysis. Photon correlation spectroscopy.
This research has been co-funded from European Society Fund and National Budget and Podkarpackie Prowince Budget in the framework of project ‘Strenghtening of institutional system introduction of Regional Innovation Strategy’ in 2007 – 2013 in Podkarpackie province carried out as part of Human Capital Operational Program
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MEPING W.Seklecki i M.Sworzyński Sp.j. mobile. 609 44 75 39 tel./fax 22 855 75 99 ul. K. Jeżewskiego 3a/27 02-796 Warszawa e-mail: maciej@meping.pl
38 | raw materials
A suitable degree of moisturisation guarantees proper functioning of skin. This very much depends on the hygroscopic properties of its horny layer and barrier capabilities that helps skin retain water.
Moisturising Dr. Eng Magdalena Sikora
an essential element of skin care
Humectants Moisturising substances used in cosmetic preparations include both
The substance also acts in synergy with preservatives, thanks to which
those capable of absorbing water in deeper layers of epidermis and those
their content in a cosmetic may be reduced. If it has the concentration of
forming a film on the surface of the skin that protects it from excessive
over 30%, it can act as a preservative itself, ensuring full protection of
moisture loss.
cosmetics. It must be borne in mind, however, that such concentrations
The former comprises hygroscopic compounds, mostly soluble in water,
may cause skin irritation, so it is sometimes replaced with higher glycols,
that are able to “attract” and hold water from the surrounding environment
e.g. butylenes glycol or pentylene glycol, which have similar characteristics,
in a lasting way, which results in increasing the degree of hydration in the
but have no adverse side effects.
horny layer. They are often called humectants.
Sorbitol is also used in cosmetic formulas. Thanks to its sweet taste,
Polyalcohols, also known as polyols, are very important members
it is regarded as the so called taste corrigent used in mouthwash and
of the group, out of which glycerine, propylene glycol and sorbitol are
toothpaste. It often replaces glycerine in lotions, milks and creams. One
the most known and most frequently used in cosmetics. They all share
disadvantage of sorbitol is that the preparation in which it is used may show
one common feature: hygroscopicity (resulting from their structures
“sticky” qualities if the concentration of the substance is high.
containing hydroxyl groups), which determines both their action and the range of usage.
Another important humectants is sodium PCA, which is one of the most essential Natural Moisturizing Factors (NMF) that ensure proper
One of the oldest substances used for skin moisturisation in cosmetics
skin moisturization. Thanks to strong hygroscopic properties and good
is glycerine. Thanks to its small molecules it has good penetrating properties
penetrating qualities, PCA and derivatives of pyroglutamic acid are major
and high hygroscopicity, which means that it can act both on the skin surface
cosmetic substances which have direct moisturising qualities. Actic acid
and in its deeper layers. Used in cosmetic preparations, it increases the
salts, among which sodium lactate is the most popular, work in a way which
ability of the horny layer to bound water, thus having a beneficial effect on
is similar to that of PCA.
biochemical processes which take place there. As a result, skin becomes soft and more elastic.
Humectants also include amino acids. These compounds are biogenic and found in the horny layer, where they constitute the biggest group of
Glycerine acts as a natural protector for the skin, penetrating its
NMF components. Amino acids are hygroscopic, enhance the moisturizing
intercellular spaces, where it retains the amount of water indispensable for
properties of other NMF components and are most often used with other
adequate skin moisturisation. Thanks to proper hydration, the substance
moisturizing substances, e.g. other derivatives, mainly actic acid and
normalises desmosomes degradation processes and thus facilitates proper
pyroglutamic acid salts.
exfoliation of the horny layer.
Hyaluronic acid (HA) is another important compound which has
Another humectant which is widely used in cosmetics is propylene
moisturising properties. It belongs to the so called mucopolysaccharides
glycol, or 1,2-propanediol. Its characteristics and range of usage are similar
and is believed to be one of the best moisturising substances that protect
to those of glycerine, although it has lower hygroscopic properties. However,
epidermis from drying. In the case of a high concentration of the acid, its
products containing glycol do not have a sticky quality which may sometimes
interweaving chains act like some kind of a molecular sponge which is
appear when glycerine is used in a cosmetic formula.
capable of effective water retention through filling the spaces between
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PENTAVITIN速 Feel deep hydration for 72 hours DSM Nutritional Products Europe Ltd. P.O. Box 2676, 4002 Basel Switzerland Phone: +41 61 815 7777 Fax: +41 61 815 7860 Email: marketing.dnpe@dsm.com
PENTAVITIN速 with its unique affinity to skin ensures instant, deep hydration by generating a moisture reservoir that lasts for 72 hours after last application. Consumer test panel confirms more than a 50% reduction in flakiness and itchiness caused by dry skin. PENTAVITIN速 is the first soothing active for hair care rinse-off products developed to deeply hydrate the scalp and relieve its sensitivity. PENTAVITIN速 is both ECOCERT approved and NATRUE certified.
40 | raw materials collagen fibres. Because of its properties hyaluronic acid is very often employed in cosmetics, in which it is used as either free or a salt. Limitations of HA usage stem from the fact that the compound whose molecular weight exceeds 100 kDa has the reduced ability to penetrate through undamaged epidermis. Therefore the acid used as a component of cosmetics may moisturise skin mainly through creating occlusive layers which decrease the TEWL factor. Even diluted solutions of the acid form a durable film which protects the horny layer of epidermis not only from losing water, but also from harmful substances. Cosmetic preparations most often have 1-5% of 1% solution of hyaluronic acid. Chondroitin sulphate has similar properties. Patent literature contains information on new compounds belonging to humectants. Substances which have recently appeared in the market and which have proven moisturising properties include e.g. glucose derivatives or glycyrrhizin, an active component of the Glycyrrhiza gabra root.
Emollients Apart from humectants, the so called emollients are also used to restore proper functioning of epidermis and to treat dry skin. In medicine, emollientia are softening and soothing agents and the word is derived from the Latin emolliare, which means to soften. Configurations of this segment create an occlusive layer on the skin surface, which protects its damaged lipid barrier that defends it from external substances and limits the loss of water and other basic substances from skin deeper layers. After emollients have been used, horny layer cells are moisturised, so they enlarge and expand, which results in reducing wrinkles and smoothing facial skin visually. Compounds of the segment have a beneficial effect on skin; what’s more, when added to a preparation they often than not improve its sensory properties after it has been applied on skin. All this means that the compounds are invaluable components of many cosmetic preparations. The number of widely-used emollients is virtually limitless. It includes polar and non-polar fluids as well as semi-solid and low-melting waxes. The properties of a single substance depend on its characteristics such as its chemical structure, molecular weight, consistence, polarity, stability, rheological and sensory properties, interaction with the surface of skin, etc.
Polar emollients, in turn, include compounds which cause a less tight
The fundamental division of emollients is associated with their polarity.
film to form on the surface of skin when they are introduced to cosmetic
For organic compounds this parameter is expressed
formulas. The most important representatives are triglycerides, liquid
through the dielectric constant and dipole moment.
waxes and certain alkoxylates. One can also mention various esters, e.g.
The polarity of oil is relative to surface tension
compounds with short chains based on alcohols C6-C12 and acids that
against water, the ability to form emulsion and
have at least one branched chain, which ensures that skin care preparations
propagate on skin. Within this division one can distinguish between polar and non-polar configurations.
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are effective. Whether consumers accept emollients as components of their cosmetics very much depends on such properties as the users’ subjective
Non-polar emollients are
feeling both directly after the substances have been applied on their skin
characterised by strong occlusive
and later. For example, plant and mineral oils may leave a rather thick film
properties, thanks to which they retain
on skin, whereas fatty acids hydrophobic esters leave lighter films which
moisture in skin and ensure its tight
provide a pleasant feeling for the skin. The compounds are an almost
protective barrier. The main compounds
unlimited source of synthetic softening agents. They are obtained in the
of this segment include hydrocarbon
process of esterification of, among other things, ethylene glycol, propylene
configurations.
glycol, glycerine polymers, isopropyl alcohol by means of various fatty acids.
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raw materials | 41
Sensory effects that they ensure and the way they act on skin are
Silicones are also an important group of emollients. Liquid substances
closely connected with the length of the chain of the fatty acid that has
of this segment, like mineral oils, have strong occlusive properties, thanks
been used to obtain the substances. Emollients with shorter chains, e.g.
to which they form a thin, water-resistant film on the surface of skin which
isopropyl myristate and octyl octanoate provide a feeling of dryness,
can perform various functions.
whereas compounds with larger structures, e.g. stearates and isostearates, provide more oily sensations.
Emollients also include plant oils. Fatty oils which are rich in vitamins are used to grease dry skins, e.g. avocado oil, apricot seed oil, hazel oil,
Vaseline is a widely-used non-polar emollient which is used separately
and almond oil. Sesame oil, apricot oil and hippophae rhamnoides oil can
or as a component of skin care and dermatologic preparations. It is also the
be used for sensitive skin, whereas sweet almond oil is recommended for
main component of many absorption bases used for dry skins. Its action is
each skin type, including the delicate baby skin.
mainly related to the creation of an occlusive base on the surface of skin which protects it from losing water and adverse external factors.
Products containing large amounts of Îł-linolenic acid (GLA), e.g. oenothera seed oil, borago oil or blackcurrant oil, are especially valuable.
Another widely-used emollient is lanolin, or refined wool grease of sheep wool.
Indispensable unsaturated fatty acids used in cosmetic preparations restore
Because of its softening properties, it has been used for thousands of years. What
acid-water-lipid balance of skin and its natural pH balance (around pH 5.5).
is important, this components acts as a softener not only through occlusion, but
They ensure that skin is properly moisturised, restore its protective functions,
also through penetrating the horny layer and retaining the absorbed water in situ
and have anti-irritant and anti-allergic properties.
as a moisture tank which ensures sufficient skin moisturisation.
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42 | Polish industry
The charm of perfumes
– alternative scents versus famous perfume brands Izabella Dudek-Urbanowicz Patent Attorney, Patpol
Saying that “a woman is dressed in perfumes” reflects the entirety of positive associations evoked by our favorite and selected scents. Each woman has her favorite perfumes kept within the reach of hand, or carried in her handbag, but she also has a special scent to be used occasionally, purchasing which is a matter of desire. The charm of perfumes is not only the very scent itself, but also the surrounding properties, such as a famous name, the shape of the bottle or packaging.
Descriptions of scents are frequently like short sublime stories in which
the very trademarks on their own is not an easy task. It is so because perfume
a scent obtains a unique character, so that its users want to be identified
names are usually applied for as word marks. In the above presented matter,
with the exceptional features enhanced by the scent, such as modernity, chic
the District Administrative Court was to determine whether there exists
or gentleness. The merits of scents are also promoted in advertising. The
similarity between the marks SILVER SHADOW and SILVER SHOW in respect
purchasers of famous perfume brands frequently want to identify themselves
of their word elements, phonetic features and the meaning. The comparative
with a well-known personality advertising the scent and attributes associated
analysis of the marks at issue was made without taking into consideration
with that personality.
how the mark for an alternative scent is used in reality. This means that the
Perfume recipes are carefully protected trade secrets. Sparing no effort
way in which the applicant affixes a trademark to his products is irrelevant
and expenditure on promotion, manufacturers would like to offer not only a
to a decision in an administrative dispute. In the discussed matter, similarity
product, but also a sense of luxury. Unfortunately, the downside of perfumes
between the above presented trademarks was not found. The authorities have
under a famous brand is usually their high price. This provides an opportunity
not found bad faith on the part of the owner of the trademark SILVER SHOW,
for alternative scent manufacturers who believe that not all customers can
arguing that bad faith should have existed at the time of filing an application
afford to buy famous perfume brands, and offer their scents at a competitive
for registration of the mark at issue, and the very fact that the manufacturer
price. Alternative scents are products that imitate original brand perfumes.
of alternative scents files on a large scale applications for trademarks which
They resemble the original perfumes in many aspects. The very alternative
are later affixed to perfumes that are cheap “counterparts” of brand perfumes,
scent is intended to imitate the scent of the original brand perfumes, and its
does not prove bad faith on his part. An analogous case occurred between
name is usually a play on wards of the name of the original product consisting
the owners of trademarks COOL WATER and COOL RIVER (which is destined
in changing the order of letters, using anagrams, or inventing names which
for the marking of an alternative scent), both the Patent Office and District
sound similar to the originals, e.g. BRUNI BANAL versus the original BRUNO
Administrative Court found no similarity, despite the fact that the packagings
BANANI, PLAZA HIPNOTIC vs. HYPNOTIC POISON, or FAHNENEID vs.
to which the trademarks at issue were affixed, were indeed very similar.
the original FAHRENHEIT. To look even more similar, the packagings, their
Conclusions regarding similarity between trademarks might be different
coloring and the shapes of bottles in which alternative scents are offered
if the Patent Office’s comparison concerned the word-figurative versions of
are very close to those used by the original brand perfume manufacturers.
marks, or their three-dimensional shapes, or if the Patent Office compared
In order to illustrate how close similarity can be, next page there is an
industrial designs representing the compared products in their entire form.
example of original brand perfumes SILVER SHADOW by Zino Davidoff and
Otherwise, even if final products of an alternative scent manufacturer and
SILVER SHOW which is its alternative scent.
manufacturer of original brand perfumes are nearly identical, the similarity
Despite striking similarity between original perfumes and alternative
between the very trademarks used for the marking of scents and perfumes
scents, when the matter is examined by the Adjudicative Board of the Patent
may not be found, and a trademark of an alternative scent manufacturer will
Office, and later by the District Administrative Court, proving similarity between
remain valid.
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However, in some cases word trademarks of alternative scent
similar to the earlier ones as repetition of letters and syllables has occurred,
manufacturers were cancelled in administrative procedure because of
and there exists a structural similarity between words resulting from an
similarity to earlier marks. A decision on cancellation was issued in the cases
accumulation of similar vowels and consonants. The Court agreed with the
of HILGER vs. HIGHER and FAHNENEID vs. FAHRENHEIT. For example, a
Patent Office that a circumstance that the trademarks at issue are word
decision on cancellation of later marks was issued in the cases of HILGER
marks, does not exclude a possibility of their distortion, especially that they
vs. HIGHER and FAHNENEID vs. FAHRENHEIT, even though in those cases
were created on the basis of words which remain fanciful for an average
the manner in which the later marks were affixed to goods was not taken into
Polish consumer.
consideration either. In both cases, the similarity of goods, for the marking of
Although assessment of similarity between trademarks which are
which the marks were destined, was unquestionable, so the Court was able
anagrams, or trademarks using predominantly the same letters, is not easy
move for comparative analysis of the marks in question. The similarity was
if the order of letters is slightly different, judicial practice shows that it is still
found in visual and phonetic respect, which was sufficient for cancellation of
possible to find similarity between this kind of marks. For example, the Court
the later marks. Pursuant to the binding case law, similarity must be found in
of first instance, by virtue of a judgment of 21st October 2008 (case file No.
at least one of the relevant aspects (visual, phonetic or semantic) in order to
T-95/07), found similarity that was claimed to exist between the trademarks
recognize trademarks as similar.
PRAZOL and PREZAL, although the syllables were not identical. However,
Examining the above cases, the Court assumed that an average customer,
it was sufficient to find that repetition of letters occurred in the subject
even though attentive and cautious, usually has no chance to compare two
trademarks, and they were words of the same length. A similar standpoint
products at the same time and place. Therefore, a customer must rely on
was repeated in a judgment of the first instance Court as of 17th November
the image of the product in his mind, which is often inaccurate. Because of
2005 (case file No. T-154/03), where a “high degree of similarity” was found
the fact that the goods under the marks HILGER and HIGHER as well as
between trademarks ALREX and ARTEX.
FAHNENEID and FAHRENHEIT are identical, and there is close similarity
The Court flatly refused to accept argumentation of an alternative scents
between the marks in visual and phonetic respect, according to the Court
manufacturer who claimed that the evaluation of the risk of confusing
there is a risk of misleading the relevant customers as to the origin of those
customers shall much depend on the fact that the goods of the parties in
goods. The term “a risk of misleading customers” shall be interpreted as the
the proceedings are from different price categories: “from the top and bottom
risk of evoking confusion as to the origin of goods. There is no need to prove
shelve.” The Court was correct in finding that the price of a product is not
genuine confusion occurring among customers of the relevant goods on
covered by trademark protection, and that it may change depending on
the market. It should be stressed that in both discussed cases an average
business strategy of the relevant undertaking.
customer of perfumery products is an occasional purchaser, whose choice of a perfumery product is in the first place determined by its scent.
To sum up, although it is fairly obvious that the intention of an alternative scent manufacturer is to create and register a trademark that would as much
In view of the fact that the questioned trademarks were created from
as possible resemble a trademark destined for perfumes under a famous
fanciful words and have no specific meaning, a possibility of their visual or
brand, it is not always possible to succeed in cancelling such alternative mark.
phonetic distortion is higher. The Court stressed that the aforesaid situation
In the case of failure, the owner of an earlier trademark for famous perfume
is more likely to happen where fanciful words sound like foreign words (do not
brand may proceed with court action in penal or civil proceedings raising
originate from the Polish language), have the same length, or are composed
claims of unfair competition.
of nearly the same letters. In the discussed cases, later trademarks become
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44 | packages
Role of packaging compatibility testing during implementation of cosmetics Joanna Jakubowska-Stokowska Dr Irena Eris
Nowadays, one can easily find a vast range of beauty products to choose from ranging from white cosmetics, i.e. facial skin and body care products such as creams, body lotions, cleansing milks, toners, gels, peelings, colour cosmetics, e.g. mascaras, nail varnishes, eye shadows, foundations, powders, to perfume products. Customers are tempted into buying these products because of their innovativeness and exquisite design.
A very important question arises for their manufacturers: what needs to be
A compatibility test consists in checking the interaction of the pair: a
done to make sure that a new marketed cosmetic is really good, safe and in line
cosmetic product/its packaging in environmental conditions that affect
with customers’ expectations? This issue is researched by many companies
it in order to check their conformity. If the result of the test is positive
engaged in marketing which look for aspects that will attract prospective
during the research stage, a decision can be made for the product to
customers and encourage them to buy a particular product.
be manufactured. The packaging is to be compatible with the product
• What comes first is packaging and its design; marketing communications
that it contains – it means that all components of a particular cosmetic
comes next. • What matters next is information on innovativeness – state-of-the-art technologies, presence of all sorts of active substances. • Colour and shape – the way a cosmetic is presented – play an essential role for a customer. • The size of a product: can it fit neatly into a small bag? Or in the case of, say, gels, is it necessary to market a family-size economic product with a pump, which will last for longer?
product do not have an adverse effect on its packaging and vice versa – the components of the packaging do not interact with the product. What is crucial in the choice of the right packaging is the knowledge of the components of the formula, since there are certain rules saying that some raw materials interact with certain sorts of packaging in an undesirable way. Compatibility tests are usually run for a specified period of time but not shorter than 8 weeks. They are carried out in room temperature and in incubators, i.e. raised temperature of usually 45 °C or 37 °C. Shorter tests
These are very important aspects, but before a safe cosmetic product is marketed, a series of tests needs to be carried out.
conducted at the temperature of 55 °C and lasting 6 days are sometimes used in specified cases.
At the very beginning, it is fundamental to create a formula meant for
Compatibility testing is testing of accelerated aging of a packaging with
cosmetics in one or more various types of packaging. The formula should
a product that is designed to specify whether it can have a shelf life of 3 years
be based on the latest technologies as well as carefully selected and tested
or less. This period and the description of how the product will behave as
raw materials which will form one product that should then be subjected to
time passes are declared by the producer.
compatibility tests of packaging in which the product is to be launched into the market.
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At the beginning of a test, a number of samples is specified to be tested in room temperature as well as raised temperature, i.e. in an incubator.
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45
Usually, there are 12 samples split into two groups (6 for room temperature/6 for an incubator). Many more samples are required in the case of foil sachets, i.e. aluminium foil tests – at least 20. If additional tests are carried out, an adequate number of samples is needed. Guidelines: 1. Before a compatibility test, both packaging and the product should be tested when it comes to their correctness. 2. If it is possible, packaging should be filled and labelled on the packing line, if a product is to have labels. If not, it is possible to fill the packaging manually. 3. Products should be divided into 2 groups and marked correctly: a. samples designed for a temperature-induced accelerated aging test: - samples (a cosmetic product + its packaging) are kept in an incubator depending on the kind of cosmetic products in the temperature of 37˚C or 45˚C, b. samples are kept in room temperature (control samples), c. samples are kept in room temperature left to be controlled after 3 years. Tested samples control: • After 4 weeks (initial assessment) if samples show abnormality, they must be submitted to a laboratory that deals with the cosmetic product, • After 8 weeks (final assessment) samples must be submitted to a laboratory that deals with the cosmetic product for review,
COSMETIC PRODUCT assessment criteria: • Appearance: checking whether the emulsion shows any changes or signs
• Control after 3 years.
of breaking or whether it has nodules; checking its density, PACKAGING assessment criteria: • Appearance: checking whether there is any damage to the packaging: – Deformation: it is advisable to measure samples at the beginning
• C olour: checking whether there are any changes to the colour of a cosmetic product, • Smell: checking whether it has not changed its smell.
of and after the test and specify the percentage of deformation, such as swelling or indentations, checked at a particular place, e.g. bottles are usually checked in the middle of their height, tubes in
Parameters of a cosmetic product should be confirmed after tests carried out by the technician responsible for its implementation.
2/3 of their height, – Leaktightness: mass decrement – when accurate research is being conducted, numerated samples are weighed at the beginning and end of the test, and then their mass decrement is specified, the
Specific and important tests: Suntest: The test consists in exposing the pair: a cosmetic product/its
percentage of mass decrement is determined depending on a
packaging to specially created conditions simulating sun’s rays from
particular group of products and their volume,
behind the display. A xenon lamp, a device made specifically for such
– Delamination: an important parameter in the case of sachets, aluminium tubes, aluminium seals, observing what is happening to the packaging, checking whether the laminate does not delaminate
kinds of aging tests, helps determine how our product will behave on a shelf lit by UV light. Parameters of the test: duration 24h ± 2h/ ATLAS Suntest CPS/CPS+ or XLS/XLS+ equipment (there are also bigger and more industrial models)
or crack; – User’s test: a cosmetic product is applied to a particular product,
with a xenon lamp, radiation 765 W/m². It would be best if the equipment
which is then checked whether it shows any signs of cracking or
had an automatic cooling system to maintain the temperature at the steady
decolouration, etc.
level of 20°C during the test.
• Colour: checking whether the packaging has not changed its colour, • Smell: checking whether the packaging has not changed its smell.
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The results should be compared against the master sample when it comes to any changes both to the packaging and the cosmetic product.
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46 | packages During such a test one often finds out whether a particular UV filter used
or by changing the mixture, or in other words the LDPE and HDPE ratio.
in transparent plastics protects the cosmetic product from decolouration.
The same applies to bottles, in the case of which greasy oil products
Observed changes:
usually cause the PE/HDPE plastics to dent. The best containers for all
• Packaging: decolouration, signs of yellowing or degradation of the material:
kinds of oils are those made of glass and PET plastics.
cracking, changes in smell, • Formula (cosmetic product): decolouration, yellowing, destabilisation.
• Change in colour – in the case of PET, i.e. the most transparent plastic, it is important to observe whether a particular product does not become turbid. When it comes to coloured products, it is vital to select a UV filter
Functionality test of all containers with ordinary foam producing (airless) pumps:
to ensure its colour durability on a shop shelf. • Resistance to the cosmetic product – it is important to check whether
When various kinds of pumps and containers with pumps are tested, it is
a particular plastic does not crack as a result of the interaction with the
necessary to control the tested samples more often for the period of 8 weeks,
active components of the cosmetic product. It is vital to test any cases of
preferably every 2 weeks:
packaging components metallisation, or silvering and gilding (hot stamping
• Dosing to be controlled (the quantity and quality of a dosage),
and cold stamping). The active components of a cosmetic product often
• Functionality – it needs to be checked whether dosing is easy and how
damage metallic decorations. Such defects become visible as a product
many times the pump is pressed before the product gets out (not more
is used, e.g. after some time we can observe how shiny metallic elements
than 10 times is optimal),
disappear from the beautiful shiny screw cap of a cream in our bathroom,
• Changes to the colour of the product as time passes (it needs to be
or even worse – the cap begins to crack although the cream has not fallen
checked whether the product is not aggressive and has not damaged
on the floor. In extreme cases, we can come across a small piece of the
e.g. the mechanism of the pump),
cracked thread or a piece of the sealing in the cream.
• C hecking the mechanism – it needs to be checked whether the
• Corrosion of packaging as a result of the interaction with a cosmetic
mechanism has not been blocked by the dried product; a suitable pump
product – in the case of aluminium containers, e.g. aerosols or metal
should be used for a particular product, the viscosity and density of the
parts such as balls in many kinds of pumps, decolouration may appear
product play a big role here,
on the cosmetic product.
• The percentage of the product being dosed from its container (minimum 85%).
Results of compatibility tests Results of compatibility tests should be presented in reports or databases
Testing free samples: sachets, mini-doses and mini-products It is crucial to carry out compatibility tests of not only cosmetics meant
created by the department that runs the tests. The results may contain three kinds of classification:
for regular sale, but also various kinds of mini-products, which are given
• 1/ compatible,
to prospective customers for free. This may have an effect on the success
• 2/ incompatible,
of a particular product in the market.
• 3/ difficult to classify.
Product sachets, which can be given away for free or found in magazines, are very popular now. They should be chosen depending on the product for which they are designed after relevant tests of foil and laminates have been
Compatible – after tests the pair a product/its packaging meets relevant requirements and can be marketed in this configuration.
carried out. The way in which foil and laminates are printed also needs to be
Incompatible - after tests the pair a product/its packaging does not meet
checked. Inter-layer print is safer, but unfortunately much more expensive
relevant requirements, it produces negative results and it cannot be
and requiring specified impressions. External flexo print with lamination
marketed in this configuration.
used for a smaller number of impressions is a good alternative, but it needs
Difficult to classify – there may be results which are difficult to interpret,
to be assessed properly whether it can be used for a particular formula. A lot
which means the tests need to be repeated or it is necessary to carry
of products are not suitable for aluminium foil mainly because it changes their
out extra ones.
smell and destabilises them quite quickly. When a suitable foil has been selected, it is necessary to determine the
When implementing a well-tested compatible product in the market,
expiry date of a particular sample. It often should be much shorter than that
one should be certain that the consumer will be satisfied with it as far as
of a regular-size product. Other mini-products such as tubes, small bottles
its functionality and safety are concerned. By failing to carry out tests, one
and jars are tested and assessed like regular products.
runs the risk of a product showing its faults after it has been marketed, which means that when used it may pose a threat to the consumer or the
Frequent packaging faults during tests – things one should pay attention to:
consumer will perceive it as faulty. As a consequence, such a product may
• DEFORMATION – shows that a particular material was wrongly selected,
market player can afford this, which is why so much research and so many
e.g. in the case of tubes, the swelling of single-layer tubes can be
tests have to be carried out during the implementation process to provide
eliminated by replacing them with EVOH-layer tubes (five-layer tubes),
customer satisfaction.
1/2012
have to be recalled from the market because of frequent complaints. No major
d o w n l o a d *. p d f v e r s i o n :
www.farmacom.com.pl
raports, projects, plans | 47
Health and beauty stores drive cosmetic market’s growth Katarzyna Twardzik PMR Retail Analyst
Health and beauty stores are the largest distribution channel for cosmetics in Poland. According to estimates presented in the PMR’s latest report entitled Retail market of cosmetics in Poland 2012. Market analysis and development forecasts for 2012-2014, this channel contributed more than 40% of sales generated by the market as a whole. The segment is moving in two tracks – one is chains, headed by the market leader Rossmann, which are quickly gaining significance, the other is represented by traditional drug stores, which are getting on worse and worse, while their number and market share is waning every year.
Chains of health and beauty stores are now the fastest growing distribution
Hypermarkets slow down pace
channel. The drivers behind the channel’s growth include the increasing
Hypermarkets enjoyed particularly high popularity as a place
number of stores run by individual chains – in particular Rossmann – which
for shopping for cosmetics and beauty care products in the 1990s
opens several dozen new outlets annually. In addition, noteworthy is the
where the key drivers of Polish consumers’ choices were a wide range
growth of per store sales of health and beauty stores. Chains lure customers
of products, low prices and frequent promotions. The significance
with good prices, frequent promotions, a wide assortment of medium-price
of hypermarkets as a distribution channel has been slowly diminishing.
segment goods and helpful staff. Furthermore, they are conveniently located:
In 2007-2011 their market share dropped by a few percentage points
in shopping centres, high streets and high traffic areas, where consumers
from more than 15%. This trend continues despite an increase in the
can shop on the way to wherever they are going while not having to visit
number of hypermarkets, which means that sales per hypermarket are
a special place, as is the case with hypermarkets.
on a decrease.
d o w n l o a d *. p d f v e r s i o n :
www.farmacom.com.pl
1/2012
48 | production raports, projects, plans
Shares of selected distribution channels for cosmetics in Poland (%), 2007 and 2011
The strongest competition for hypermarkets comes from specialist
Rossmann in the lead
health and beauty store chains. Not only do they offer good prices, but
The dynamic growth of the chain store distribution channel mostly benefits
they also carry wide ranges of products, provide customers with expert
from the increase in sales due to the largest chains, including Rossmann,
consultations and offer various promotions. As a result, although the
Drogerie Natura, Super-Pharm and Sephora and Douglas perfumery chains.
number of hypermarkets is growing, their market share is steadily shrinking.
In 2007-2011, sales of the leading chains grew at the annual rate of 24%
Furthermore, part of customers shift to smaller format stores, such as
and accounted for well above PLN 6bn in 2011. The number of chain stores
supermarkets and discount stores. Their growing popularity reflects the fact
increased by more than 700 outlets.
that even hypermarket operators expand their business profile to include
The key driver behind the growth of the health and beauty store segment
supermarkets, which is also the effect of gradual saturation of the market
is its leader Rossmann, which stepped up the pace of new openings to an
with large stores. This strategy is already followed by Tesco and Carrefour.
average of 70 annually; this in turn resulted in an annual sales increase of
1/2012
d o w n l o a d *. p d f v e r s i o n :
www.farmacom.com.pl
raports, projects, plans | 49
Preferred places when shopping for cosmetics in Poland, January 2012 Preferred places when shopping for cosmetics in Poland, January 2012 Health and beauty stores and cosmetic stores Hypermarkets/supermarkets/discount stores
Health and beauty stores and cosmetic stores Sales consultants Hypermarkets/supermarkets/discont stores
Local cosmetic stores Sales consultants
Online stores stores Local cosmetic
Online stores Pharmacies Pharmacies Bazaars, open-air markets Bazaars, open-air markets Note: single-choice question. Based on responses provided by 395 respondents.
Note: single-choice question. Based on responses provided by 395 respondents. Source: report Retail market of cosmetics in Poland 2012. Source: Retail of cosmetics in Poland Market report analysis andmarket development forecasts for 2012. 2012-2014, PMR Research, 2012 www.pmrpublications.com www.pmrpublications.com Market analysis and development forecasts for 2012-2014, PMR Research, 2012
30% on average. We estimate that Rossmann’s sales totalled around PLN
and cosmetics stores, as indicated by a staggering 62% of respondents.
4bn in 2011, which means that the chain now contributes more than 45% of
Large-space stores, including hypermarkets, supermarkets, and discount
the health and beauty store segment’s sales in Poland.
stores (18% of responses) ranked second – cosmetics are purchased during
Rossmann, which originally opened stores mostly in large cities, has
regular shopping trips. Thus, Poles’ preferences reflect market developments.
recently shifted part of its attention to much smaller locations inhabited by
The development of health and beauty stores and cosmetics stores, which
up to 20,000 residents where, to date, traditional cosmetics stores prevailed.
has been observed for several years, shows that consumers, mostly females, (a steep 69% of women preferred this distribution channel) increasingly
Market development and consumer preferences According to the consumer study which PMR Research (PMR’s research
decide to use more expensive products, expect a wide assortment and the assistance of store staff.
division) conducted for the purposes of the report in January this year, the
Large-area stores (including local stores) are the most popular with men.
preferred place of Poles shopping for cosmetics are health and beauty stores
As many as 59% of male respondents choose to shop at hypermarkets, and
d o w n l o a d *. p d f v e r s i o n :
www.farmacom.com.pl
1/2012
50 | raports, projects, plans
55% prefer to stop by a local store near the place they live. These results
Criteria governing selection of cosmetics
confirm that men purchase cosmetics as part of larger shopping trips more
Poles subscribe to the view that they use tested cosmetics, get
often than women. Women tend to buy cosmetics as part of an independent
accustomed to brands and remain loyal to them. In addition, they are not
consumer behaviour. In addition, women frequently choose more expensive,
particularly willing to look for novelties. So, what is the criterion behind the
specialist products, which are usually not available from grocery stores.
selection of a given cosmetic?
Choosing the place to buy cosmetics
the qualities of the products, which depend on cosmetic type. The second
Most (66%) of buyers of cosmetics (44% of adult Poles) pay attention to The criterion most frequently mentioned by respondents as the key driver
most important selection criterion for cosmetics is the price (40%). It should be
for choosing a place to shop for cosmetics was the convenient location (34% of
noted here that the price starts to play a major role when products of similar
responses). A convenient location denotes accessibility, proximity, easy access
qualities which are priced in a comparable range come into play. One-third
by car and availability of parking space. Another criterion in the ranking was the
of respondents concentrate on the scent, and 13% claim that they must
price. 22% of responses indicated a wide assortment of products. One more
feel the product. The product’s brand, which is a highly important feature of
criterion that garnered more than 10% of responses was store brand. Why this
cosmetics, is ranked fourth. It appears that this feature is underestimated
store and not the other is a vital question especially in the case of products
as, similar to the price, it influences purchasing decisions of buyers more
from the top price bracket, which are available only from selected points of sale.
than respondents admit.
1/2012
d o w n l o a d *. p d f v e r s i o n :
www.farmacom.com.pl
mieszalniki mieszalniki homogenizacyjne, homogenizacyjne, reaktory reaktoryprocesowe procesowe
sterylizatory, sterylizatory, sterylizatory, sterylizatory, suszarnie, suszarnie, suszarnie, suszarnie, komory komory do do mycia mycia komory komory dodo mycia mycia i dezynfekcji i dezynfekcji i dezynfekcji i dezynfekcji szybkie szybkie i zwarte i zwarte maszyny maszyny szybkie szybkie i zwarte ikartoniarki zwarte maszyny maszyny blistrowe, blistrowe, kartoniarki blistrowe, blistrowe, kartoniarki kartoniarki
nalewaczki, nalewaczki, nalewaczki, nalewaczki, zamykarki zamykarki zamykarki zamykarki
mieszalniki mieszalniki mieszalniki mieszalniki homogenizacyjne, homogenizacyjne, homogenizacyjne, homogenizacyjne, reaktory reaktory procesowe procesowe reaktory reaktory procesowe procesowe
saszetarki saszetarki poziome poziomei pionowe i pionowe
saszetarki saszetarki saszetarki saszetarki poziome poziome i pionowe i pionowe poziome poziome i pionowe i pionowe
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