Every cosmetic product that reaches the market, even natural and eco-biological, must have passed safety tests to ensure that it reaches the consumer in full compliance with rigorous chemical-physical, microbiological, formulation and toxicological requirements.
Ensuring safety for the consumer and end user is a priority, find out which tests are carried out!
Safety of cosmetic products: the tests
Every cosmetic on the market has what we can define as a European patent, a document that guarantees its safety and is drawn up after the product has passed all the tests.
Even before all this happens, a responsible person must be designated, in fact the European Regulation (EC) 1223/2009 , in its article 4 imposes that only cosmetics for which a Responsible Person has been designated can be placed on the market . This person can be physical or legal , such as for example the manufacturing company, the importer or the distributor.
Articles 10 and 11 then insert the request for the production of Product Information Documentation, the PIF - Product Information File , which in its second part contains the Safety Assessment, the Safety Report.
The ingredients used in the formulation are tested and evaluated, as well as the formulation itself , from its physical-chemical and microbiological properties to the manufacturing method, and existing data and evidence on the effects on human health caused by the cosmetic product following its use are reviewed.
Subsequently, always before being placed on the European market , the product must be notified to the CPNP - Cosmetic Product Notification Portal
CPNP will then make this official information available electronically to :
- competent supervisory authorities
- Market analysis
- Consumer evaluation and information
- poison control centres or similar European organisations
Having timely access to this information, for example in the event of a serious and unexpected allergic reaction, is of fundamental importance.
At this point the cosmetic is ready to be labelled!
This phase is regulated by Article 19 of Regulation (EC) 1223/2009.
What should every cosmetic label indicate?
Each label on the packaging, i.e. the bottle, must necessarily report some information, this:
- the function of the cosmetic : face cream, hair conditioner etc.
- INCI or the list of ingredients according to the International Nomenclature
- any precautions , for example avoiding contact with eyes and other
- Company name or name of the Responsible Person
- the nominal quantity at the time of bottling, e.g. 200 ml, 100 g etc.
- expiration date or PAO - Period after Opening.
- the manufacturing batch reference , which must be printed indelibly and is a numeric or alphanumeric code that identifies the production batch.
Through the batch number it is possible to trace the processing phases, the raw materials used and the production period. Of fundamental importance because in case of formulation or even health problems , through the acronym, it is possible to identify and possibly withdraw from the market the cosmetics belonging to the specific production batch.
But specifically, what tests were the formulas subjected to before being prepared, packaged and then distributed?
What safety tests do cosmetics undergo?
After the formula has been created , always associated with a scrupulous regulatory check-up of the individual raw materials and the finished product, tests are carried out in the cosmetic laboratories which, if passed, will guarantee the safety of the product.
There are three mandatory and necessary tests that every cosmetic must pass before being placed on the market.
- Microbiological analysis
- Stability Test + Compatibility Test
- Challenge Test or In-USE Test
Microbiological analysis
With the exception of those considered to be at low microbiological risk,
- products with high or low pH
- products with low water content or anhydrous, without water
- alcohol-based products
- products with raw materials hostile to microbiological proliferation
All cosmetics must be subjected to microbiological testing to ensure that the product falls within the specifications of categories 1 and 2 of the European standard ISO 17516:2014 which establishes the acceptable quantitative and qualitative microbiological limits for finished cosmetic products, in particular for mesophilic aerobic microorganisms and specific microorganisms such as:
- E. coli
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Candida albicans
All microbiological specifications must be attached to the PIF Safety Assessment, paying additional attention to those of cosmetic products for sensitive areas of the body, such as mucous membranes or those intended for children under three years of age.
Microbiological analyses must always be repeated on each production batch . They are essential to guarantee the safety and health of the consumer.
Stability test and compatibility test
Stability Tests are performed to evaluate whether or not a product maintains its chemical-physical quality characteristics, its safety, its functionality and its intact texture and fragrance.
In fact, when a cosmetic leaves the laboratory it is immediately subjected to various stress factors, storage, transport, climate and even just the passing of time!
These tests simulate the possible stresses that the cosmetic will encounter and make it possible to evaluate whether the cosmetic will remain within strict limits of acceptability.
The results of the stability tests must be reported and considered, mandatorily, in the PIF Safety Assessment.
There are no mandatory standard procedures; the company defines internal protocols by establishing the exposure conditions to which the product is subjected , the time intervals at which to evaluate the progress of the tests and the parameters to be assessed.
Typically, the conditions to which cosmetic samples are subjected are:
- Exposure to high temperatures;
- Exposure to high humidity;
- Cyclic tests with exposure to temperature and/or humidity conditions varied at regular intervals;
- Freezing/thawing tests for products that may crystallize or become opaque or for two-phase systems (emulsions);
- Exposure to light;
- Mechanical stress test;
- Thermal shock test
The cosmetic is subjected to these stability tests in an accelerated manner.
In addition to the Stability Tests on the product, Compatibility Tests must be carried out between the product itself and the packaging, to ensure that
- the packaging does not alter the product and vice versa
- do not experience frequent breakages or deformations of the container;
- the packaging is kept correctly and any product is lost;
- no reduction in product weight occurs
Challenge test
The Challenge test is carried out on all cosmetics that have a preservative system that protects them from microbiological attacks.
It allows to evaluate the effectiveness of the latter because during this test the microbiological stress to which the cosmetic product will be subjected once it leaves the laboratory and is placed on the market is simulated .
The test is carried out with artificial contamination of the product by inoculation of microorganisms into the cosmetic.
There is no official method but the reference standard isISO 11930:2012 which provides parameters such as analytical methods, the strains of microorganisms to be used and the method of interpreting the results.
The microorganisms with which the product sample is contaminated for the test are
- Pseudomonas aeruginosa
- Staphylococcus aureus
- E. coli
- Candida albicans
- Aspergillus brasiliensis
After the preliminary evaluation of the sample, and after contamination, the decrease in contamination of the product itself is evaluated at predefined time intervals.
- T0: time zero is the moment of contamination.
- T1: after 24 hours
- T2: after 48 hours
- T7: after the seventh day
- T14: after 14 days
- T28: after the twenty-eighth day to verify the total lack of the initial microbiological load
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Compliance with Criterion A: the microbiological risk is acceptable, the cosmetic is considered protected against microbial proliferation per se.
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Compliance with Criterion B: the microbiological risk is acceptable, but the microbiological risk assessment must also take into account other factors in addition to the formulation itself, such as the type of packaging, perhaps airless instead of jar, to reduce the microbiological risk.
- Non-compliance: the preservative system is not suitable.
The Challenge test is a test that must be carried out on all cosmetic products that , under normal storage and use conditions, present a risk of bacteriological contamination.
Only products with a very low microbiological risk such as alcohol-based products and products with a basic pH such as soaps are exempt from these tests.
But there is another test for them!
In-Use Test
For cosmetic products characterized by the absence of a preservative system , where therefore the challenge test would not give a logical result, we proceed to the In Use Test , that is the real use of a product by a variable number of sample consumers who will have to use it as per its function. After a period of use, the costs will be evaluated to verify whether, after the real use of the cosmetic, the microbiological values fall within the suitability limits.
The outcome of the Stability Tests, Compatibility Tests, Microbiological analyses and Challenge tests or in-Use Tests is essential for defining the minimum shelf life date, from which the expiry date will be established, or the PAO Period after Opening.
In the Beauty Blog Yumibio I explain the differences between cosmetic expiration and PAO.
The most common non-mandatory tests on cosmetics
In addition to the microbiological tests required by law, cosmetics can be subjected to other tests to ascertain their characteristics and properties.
These clinical tests are divided into two macro categories :
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In vivo clinical trials: these are performed on a controlled group of volunteers, following the ethical principles of the Declaration of Helsinki regarding medical research involving human subjects and under the careful supervision of a specialist.
- In vitro clinical tests: these are used to evaluate the biological characteristics of cosmetic ingredients to assess their safety and specific functionality.
Let's see what the main tests are
Patch-testing
The Patch Test is carried out in vivo, evaluates the extent of irritation of a cosmetic and verifies that there are no irritating effects following the application of a product on the skin or mucous membrane.
Allergens, called haptens, are applied to the skin under standardized conditions.
This test is always carried out under the careful supervision of a dermatologist to check whether or not the cosmetic causes the appearance of irritation, such as erythema and edema.
At the end of the exposure period, skin responses are evaluated and a score is assigned ranging from 0 - no adverse reaction to 4 - severe reaction.
Although the Patch test is not mandatory, it is very important to evaluate the skin tolerability of the product. Products subjected to this test may have the wording "Dermatologically tested" on the label.
Patch test on sensitive skin
The same test but carried out on a sample of subjects with sensitive skin and, if passed, guarantees the very high tolerability of the products even on people with hypersensitive skin, such as children, skin problems or intended for specific areas of the body.
Heavy metal testing
It is used to verify the degree of presence of Nickel, Lead, Chromium and Cobalt in products.
Heavy metals are substances distributed in the environment, in food and water, it is impossible to avoid daily exposure but we are talking about infinitesimal quantities. In cosmetics their presence is tolerated only if in traces called technically unavoidable.
The presence of heavy metals is accepted only if:
- Heavy metals are present at technically unavoidable trace levels;
- If their presence occurs despite compliance with good manufacturing practices;
- The Istituto Superiore di Sanità (ISS) has indicated the maximum limits that can be considered technically unavoidable traces.
"Nickel tested" cosmetics are highly sought after because many everyday objects may contain this metal and numerous allergies have developed.
Nickel test or Nickel test
Nickel allergy is one of the most common contact allergies and this is the most frequently performed test.
As with other heavy metal tests, it is up to the manufacturer to decide whether or not to perform them. This test evaluates the sensitization potential and the value of 1 ppm - one part per million - is considered the threshold:
Nickel concentrations below the tolerance limit of 1 ppm are considered safe and without sensitizing potential. In order to include the wording "Nickel Tested < 1 ppm" on the label , the requirements must be met; the test must be performed and repeated on each production batch.
Clinical comedogenicity test
An in vivo test that allows to verify whether the product has comedogenic effects or not, both open, blackheads, closed, whiteheads and that does not worsen the condition of any existing ones.
Ophthalmological test
A test performed in vitro or in vivo to verify whether the product causes eye irritation as a side effect.
For cosmetic products intended for use in the periocular area or at risk of contact with the eyes such as children's bath foam, a clinical ophthalmological evaluation can be carried out to define the tolerability of the periocular mucosa to the use of the product.
The ophthalmologist evaluates, with respect to certain parameters and observation times, the appearance of erythema, edema, and tearing.
