Market Your Cosmetics
In Europe with Safety
Compliance to European safety regulations for cosmetic products, final formulations and ingredients.
THE MARKET for cosmetic products is large and was estimated globally at €175 billion in 2013 (or approx. $227 billion).1 The largest market is Europe estimated at one-third of the
global cosmetics market.2 With its large size, the European Union
(EU) is a key component of the business strategy of most cosmetic companies, suppliers of final formulations and ingredients.
To achieve their goals, companies must comply with European
regulations. In today’s global world, even if the European market
is not the primary target, it is nevertheless a good approach to
think globally and to integrate European regulations right from
the beginning of the marketing efforts. This ensures that some
expenses are not repeated due to lack of compliance and that
companies are ready when opportunities arise.
Regulation (EC) No. 1223/2009, published in 2009, (which replaced the Cosmetics Directive) is the primary legislation govern-ing the area of cosmetic products in Europe and is fully applicable
since July 11, 2013.3 A key objective of this European regulation
for cosmetic (substances), final formulations and ingredients is
the health safety to consumers. Before being placed on the market, the cosmetic product must undergo a safety assessment.
The Scientific Committee on Consumer Safety (SCCS) has offered guidance on the safety evaluation of cosmetic products in
December 2012.4 In addition, the European Commission published in November 2013 guidelines to help when assessing the
safety of cosmetic products. 5
This article focus on the safety data in relation with the regulation and provide some recommendations on what to do.
Cosmetic Products (Final Formulations)
Regulation (EC) No. 1223/2009 main objective is the safety of a
cosmetic product for human health: “A cosmetic product made
available on the market shall be safe for human health when
used under normal or reasonably foreseeable conditions of use“
The regulation describes what elements are mandatory to be
able to market a cosmetic product within the EU as an in-market
process. Three series of documents are critical for the safety: a
Product Information File (PIF) is required to be drawn up for
each product before it is placed on the market (Art. 11) and it
includes 5 sections. One of these sections, a Cosmetic Product
Safety Report (CPSR) must be prepared that includes a Cosmetic
Product Safety Assessment (Article 10). From a safety point of
view, the CPSR is the most important element of the PIF and
referred to in Article 10(1).
The Cosmetic Product Safety Report
Manufacturers need to follow specific requirements in the prepa-
ration of a product safety report prior to placing a product on the
market, and particularly, a“Responsible Person” has to be desig-
nated within the Community (Article 4). As stated in Article 10,
“in order to demonstrate that a cosmetic product complies with
Article 3, the Responsible Person shall, prior to placing a cos-
metic product on the market, ensure that the cosmetic product
has undergone a safety assessment on the basis of the relevant
information and that a cosmetic product safety report is set-up in
accordance with Annex I.”
A CPSR must be prepared for every product placed on the
EU market. The minimum content of the CPSR is listed in Annex
I of the Regulation 1223/2009. It is to contain, “as a minimum,”
the information required under each of the headings of Part A,
Cosmetic product safety information, and Part B, Cosmetic prod-
uct safety assessment. Part A aims to gather all the data necessary
for the safety assessment of the product, while Part B sets out the
reasoning, starting from the data, for drawing conclusions as to
the safety of the product.
Part A includes 10 sections and a previous paper provided an
overview of them. 6 From a safety point of view, the most impor-
tant element is section 8: Toxicological profile of the substances.
The aim of this section is to describe the toxicological hazard of
each of the substances in the finished product, determine the po-
tential exposure, and draw up a risk characterization. The toxi-
cological profile may address a number of different endpoints.
A final decision about which endpoints are relevant is made by
the safety assessor on a case-by-case basis, taking into account
exposure, use of the product, physico-chemical characteristics of
the substances, experience with the substances, etc. Endpoints
that may be relevant for the toxicological profile include data on:
• Skin absorption,
• Chronic toxicity via relevant routes of exposure,
• Skin and eye irritation,
Pascal Yvon • IDEA TESTS Group