We offer regulatory consultancy for the importation and marketing of cosmetic products. Finding one's way in the new regulation is becoming more and more difficult. This slide includes only the questions asked by our customers.

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Control list of permitted substances
Not all substances may be used in a cosmetic. EC Regulation
1223/2009 has Annexes that regulate the presence of substances
such as preservatives, colorants and UV-filters.
Not only that, the legislation provides a long list of substances that
may only be permitted in specific product types and concentrations,
and others that must be totally absent in a cosmetic product. The
verification of compliance with regulations is, above all, from the point
of view of the formulation, the first step in having a cosmetic accepted
at a European level.

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Preparation and control of labels
Article 19 of EC Regulation 1223/2009 specifies the minimum
requirements of the label of a cosmetic product. Each type of product
may have to comply in a different manner to meet legal requirements,
making it sometimes difficult for new companies or those who are only
engaged in a commercial activity to attain the labels according to the
law.
The supervision of the texts by a technical consultant eases the task
for companies and allows them to disentangle themselves from the
sometimes delicate legislation on claims and actions vaunted for the
product.

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Preparation and verification of publicity texts
Unlike other product sectors, such as medical devices, the advertising of
cosmetic products does not need to be authorized by the Ministry of Health.
However, it remains the obligation of the company to comply with cosmetics
regulations in force, which impose certain constraints on communication to
the public. Failure to comply with the law, even for simple negligence and in
good faith by the company, may result in penalties commensurate with the
extent of fault ranging from monetary fines, withdrawal of the product from the
market or, in more severe cases, may incur criminal liability.
An experienced technician can allow the company to recognize the limits
within which they may use correct publicity information, avoiding damage, at
times serious, to the company.

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Notification of import of cosmetics and
initiating commercialization
EC Regulation 1223/2009, which will be in force as of 11 July 2013,
provides for a precise procedure of notification of cosmetic products,
which is necessary in order to place the product on the market. The
notification includes a first registration of the company in the
European database and the subsequent notification of the cosmetic.
This procedure is centralized at the European level and fully
electronic. Up to July 2013 it will still be necessary to notify the
product in accordance with national regulations, which often differ
from country to country and especially with the new procedure. It will
be an assured aid for companies to have a consultant who can follow
the entire process of notification, right up to its completion.

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Preparation and correction package
leaflets
Examination of printed materials and documentation: as well as the
text of the labels and advertising, the drafting of a package leaflet
must also follow very specific rules.
This type of communication is to be configured not only as informative
on the quality of the product or, in certain cases, an entire line of
cosmetics, but for those cosmetics with small packaging, with a sole
font, compulsory by law with all essential information that the
consumer must receive, according to EC Regulation 1223/2009.
Once again the support of a qualified technician to correct the drafting
of texts and assist the company is fundamental for compliance.

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Evaluation of safety
EC Regulation 1223/2009 places great importance on the safety of
the product. Article 10 states that every product must be safe and that
safety, within reasonable profiles, must be evaluated and proven by
scientific evidence by a Safety Assessor. Thus there is a need to
define a new normative figure that in order to fulfil his/her role, must
be in possession of particular requirements established by law.
Relying on a Safety Assessor with the right training and experience
enables the company to ensure that the legal requirements on the
safety and quality of the cosmetic product are respected, allowing for
a safer marketing of the product itself.

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Preparation of the technical dossier
A further obligation to which the cosmetic companies must comply in
order to market a cosmetic product is the preparation of a Product
Information File. This documentation must be conceived as a dossier
that contains all possible information on the product, starting from the
manufacturing process, the texts present on the label, possible
indications for use, together with all data relating to the safety, toxicity
and chemical / physical and microbiological characteristics, as well as
the stability not only of the finished product, but also of each
ingredient used for the production. The Product Information File also
includes the Safety Assessment prepared by the Safety Assessor,
which take into account all the data in the PIF, processing and
verifying the "big picture" which is delineated, thus generating a
document to be submitted to the competent authorities if requested by
them.

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Request for Certificates of Free Sale
Some countries outside the European Union require a Certificate of
Free Sale issued by the Ministry of Health, to allow entry of Italian
cosmetic products into their territory. It is important for companies to
have a consultant who can take care of every aspect of the procedure,
from the progress with the Ministry of Health until the completion of
the entire procedure.

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Preparation of the graphic design of
cosmetic packaging
Cosmetic products, more than others, need to combine accurate
information on the product with graphics designed in every detail.
Having within the team of consultants an experienced graphic
designer allows the company to receive a complete consultation that
takes into account not only the accuracy of the texts from a regulatory
point of view or technical information provided to the consumer, but
also the graphic and aesthetic appearance, thus making better use of
the available space on the packaging.