Saturday, April 16, 2011Cosmetics news

A suit-case full of regulations for home-designed cosmetics

© L'Observatoire des Cosmétiques

A good news for all of you who have once been in the mood for designing their own cosmetics and selling them to the public at large, without any idea how to begin with: CosmeticOBS-L’Observatoire des Cosmétiques is here to help you!

Reading time
~ 8 minutes

April 15, 2011
Let us begin with a nice reminder: contrary to pharmaceuticals, cosmetic products do not need any marketing authorization. Nevertheless, manufacturers have to comply with the requirements of the Directive 76/768/CEE (soon to be replaced by the European Regulation  1223/2009 on Cosmetic Products). These requirements are there to assure consumers of the safety of the cosmetics they use.

You are a novice? Let us have a look to all the mandatory or recommended steps needed to market a cosmetic product.

Step nbr 1: declaration of the manufacturing site (for France only)

Before placing a cosmetic product on the market, every manufacturer has to fill in a form, "déclaration d’établissement", in French, which could be understood as the manufacturing site, and send it to the French Agency for sanitary safety of Health products ( Afssaps , the French acronym). This document states where the raw materials and the finished product will be manufactured, packed and stored as well as the required professional and scientific qualification of the person responsible for the marketing of this product. This person may be the manufacturer, a sub-contractor or any other people involved in the company who has the required qualification. This person is responsible to the authorities for the manufactured products. This person shall ensure the safety of the production and formally agrees to comply with all the regulatory requirements. Anyone who wants to open a manufacturing, packing or importing site for cosmetic products may download a printed form from the Afssaps website. This French requirement may be modified when the new Regulation is implemented, for it contains a new definition of the "responsible person".

Step nbr 2: the good manufacturing practices

The good manufacturing practices are set to ensure of the quality and the safety of a product throughout its manufacturing process by using suitable and safe working conditions (premises, quality, production, ventilation, storage …). The current Directive gives no clue as for how to implement these practices. The Regulation on Cosmetic Products, mandatory in July 2013, requires companies to detail the way they will comply. Nevertheless, no general rule or frame of reference is specified. Companies will have to establish their own rules. However, it may be useful to know the ISO 22716 international standard, issued in 2007, which is a kind of reference for almost all the manufacturers, with many examples. This standard gives very useful guidelines.

Step nbr 3: the product information file

Prior to marketing a cosmetic product, the manufacturer has to gather many pieces of information. This makes for the Product Information File , which may be seen as the product’s ID. It compiles many mandatory technical pieces of information on the product, its manufacturing and the raw materials. This file shall be made available to the authorities on request, at the address of the responsible person, as displayed on labels. What is to be found in the PIF?

The qualitative and quantitative formula of the product : all the ingredients, their respective quantities and their INCI name shall be recorded.
The physical, chemical and microbiological properties of the ingredients . In other words, all the Material Safety Data Sheets (MSDS), and the Technical Data Sheets (TDS) of the ingredients shall be recorded, as well as the results of the challenge-test of the finished product (mandatory test used to assess the efficiency of the preservative system), and all the data about the tests of stability.
The description of the manufacturing and quality control processes, complying with the good manufacturing practices . This information deals with the manufacturing steps, equipment, procedures, controls performed at each step, cleaning procedures …
Assessment of the safety of the finished product for the human health (toxicological profile) . This assessment will be made by an expert, who, depending on the data about the product (list of ingredients, area where the product is to be applied, "arget people", frequency of application …), will guess whether this product could be of concern for human health. This expert may also give additional advice for use or draw the attention on potential intolerances (mucous membranes, eyes …).

Name and address of the qualified person(s) responsible of the evaluation of the sanitary safety for the human health , along their professional qualification.
Evidence of the effect claimed for the product, when the kind of the effect or of the product makes it useful . In fact, the records of the efficiency tests, depending on the claimed effects, come as a proof. Tests performed on voluntary consumers may be enough to give evidence of the effect.
Known data of undesirable effects on the human health when the cosmetic product is used : tests performed on voluntary consumers give these data, in addition to data gathered after marketing the product (effects of the product on consumers, complaints about undesirable effects …).
Proof that the formula has been sent to Poison Control Centers : in France, Paris, Marseille and Lyon centers. A proof of delivery is enough to comply.
• Data about animal testing: which alternatives methods have been used, if any, in lieu of animal testing of the finished product. Regarding the ingredients, if they have not been animal tested, a certificate by the supplier added to the Product Information File is enough.

Step nbr 4: Labelling and determining the Period-After-Opening

All cosmetics must come with some mandatory pieces of information. The European Directive specifies labelling rules. Thus, the product meets the requirements when its label displays:

• name of the manufacturer or of the person responsible for the marketing, or its brand, its address or the company central office’s address;
• the nominal volume or mass;
• the "Best before …" date , for products whose life span is less than 30 months, or a "Period-After-Opening" for those that may be used without any risk after 30 months from manufacturing. This information is displayed as an open jar ;
• specific precautions for use;
• the batch number, or any means allowing for the determining of the batch;
• which use it is intended for;
• the INCI list of ingredients under the word “Ingredients”.

Regarding the determination of the Period-After-Opening , it comes after tests have been performed at different temperatures to have a better idea of the formula changes along the time. Depending on results, a length of time is stated. At least in France, in addition to the tests, Afssaps has a formula to calculate this period depending on several parameters: formulation, relationship product/environment (is the product directly in contact with the outside, or kept free of any contact?); the anticipated time needed to use the product (volume/usual dose/frequency ratio); the area of application; the “target users”. This method is a means to better the results of the stability tests.

With this complete knowledge of the rules to follow, marketing a cosmetic product, how it shall be used and what it becomes when used should not be a worry for you! Quite an easy task, you bet! Nevertheless, there is one thing you cannot download, or order, from the Internet: the key for the entire process. Money!

Marion Lamarque
© 2011- 2020  CosmeticOBS

Cosmetics newsOther articles