The safety assessment of both the cosmetic products and the cosmetic ingredients represents a challenge for the manufacturers and for all the players (including importers and distributors) willing to stay in the EU cosmetic market. That happens as a consequence of the entry into force of the new European Cosmetic Regulation (1223/2009); furthermore the animal testing ban will fully apply this year on March. We discuss some regulatory issues regarding cosmetics with Silvia Boracchi from Ager, a contract testing laboratory placed near Milan, in Italy. She joined the cosmetic industry as a microbiologist, entering as a partner with the company Ager, where she is currently in charge of the Scientific Direction with direct responsibility on the products safety evaluation. Silvia Boracchi is active in different regulatory and toxicological advisory and steering groups both at national and international level. Since 2004 she is Chairperson of the Working Group Regulatory Affairs & Product Safety within the European Federation for Cosmetic Ingredients (EFfCI,Brussels).
Cosmetic manufacturers are now getting ready to prepare and maintain Cosmetic Product Safety Reports for the products which will be on the EU market after July 11 this year. Which are the major difficulties you see in the everyday’s practice?
In our experience, the major problem is the assembling of an adequate Product Information File, completed with all the information needed to prepare the Cosmetic Product Safety Report. This is especially true in the case of small companies, sometimes lacking of an internal technical staff dedicated to this time consuming exercise. In fact, one must be able to collect and organize all the relevant elements in support of the safety of the product, coming from different areas within the company: Technical and Safety Data Sheets must be provided by the Ingredients Suppliers, stability and safety testing on the finished products realized either internally or by external laboratories are usually held by the R&D, information for the consumers has been defined by the marketing department… Moreover, there is a new element in the needed technical data set, represented by the information on the primary packaging: Annex I to the Cosmetic Regulation requires the safety assessor to evaluate the relevant characteristics of packaging materials, in order to assess its purity and stability, and it is sometimes an exercise to collect all the qualifying information for a certain piece of packaging, even because the legal request is new, and the personnel in charge of the regulatory affairs is sometimes not yet familiar with the sector of packaging suppliers.
On the strength of your safety evaluation experience, which kind of services do the industries of cosmetic ingredients require to the testing laboratories?
With the implementation of the animal testing ban, the practice of toxicological risk assessment on cosmetic ingredients has been forced to some quick changes: in all cases where a full toxicological data, inclusive of data from animal testing, is not available (and that means for all new ingredients after March 2013!) the substantiation of the safety evaluation will need to be based on certain type of data only – the so-called alternative tools. Of course it must be clear that such alternative tools will not guarantee in all cases the possibility to come to definite conclusions concerning the safety of use of a certain ingredient, nevertheless the attention of testing laboratories and safety evaluators focus now, even more than in the past, on particular type of data, which have always been considered relevant in the risk assessment, but which will represent in the future the only available tools to safety assessors.
Which are the best methodologies approaches for the safety evaluation of cosmetic raw materials?
A big importance is given to the full chemical characterisation of the substances, with a thorough knowledge of their purity and possible present impurities. It is also essential to know the dermal absorption potential of the substance under evaluation: the logically consequent step is the use of in silico tools, that is the adoption of software and other computer based systems to predict toxicological properties of the substances. Last but not least, of course, there are the in vitro tests, and it must be acknowledged that science has achieved important results in this field, even if the full solution of the problem is still to be seen. For example, we can estimate in vitro the dermal absorption of substances, relevant aspects of their mutagenic and genotoxic potential, their skin irritation potential. Overall, it is important that safety assessors in the cosmetic field do possess a serious expertise in the application of the “Weight of Evidence” approach: they must be able to make a scientifically valid use of all the relevant elements at their disposal.
The animal testing ban spreads the preoccupation that the marketing of innovative cosmetic raw materials could be slackened. Which are the R&D strategies of innovation oriented manufacturers?
The full implementation of the upcoming animal testing ban will deprive toxicologists of the traditional “standard” tool used to assess the safety profile of chemical substances: data from animal testing. It is important to remind that animal testing is often still the only available tool which is legally recognized for the identification of certain toxic properties (e.g. eye irritation, skin sensitization, reproductive toxicity, etc). This limitation will heavily affect the possibility to develop innovative ingredients for the EU cosmetic market – and Cosmetic Ingredients Suppliers are concerned that in many cases it will only be possible to place such ingredients on extra-UE markets. Consequently, there is the possibility that Europe could get only “less innovative” ingredients, with big multinational companies moving R&D centers and manufacturing plants outsideEurope, while small/medium companies, not having similar resources, would be automatically put out of game. The foreseeable negative consequences are on both sides: damage for our industry and for our consumers.
To export to the emerging markets is an important opportunity for the enterprises. Which are the challenges from a regulatory point of view?
It’s not always easy to comply to the emerging markets countries regulatory issues. For example,Chinalegislation requires animal testing data to issue the registration and authorization of imported chemicals, including cosmetic ingredients. Considering cosmetic products, it is necessary to check if every single ingredient of the formulation has to be submitted to registration. New substances need a long and uneasy submission procedure in this country. Furthermore, an official list of the existing ingredients is not available inChinaand this makes the process even more complicated. So the ability of local partners could be decisive in this market.
Consumers seem to show increasing appreciation for natural ingredients. Are there any best standards to define natural ingredients in the product claims?
Of course the interest and the affection of the consumers for “natural” ingredients are constantly confirmed by market research and this trend does not seem to decrease. Linked to the concept of “natural” there is a permanent discussion relating to the correct criteria to be adopted to define “natural” a cosmetic ingredient: to which extent can be a naturally derived ingredient be manipulated and chemically treated in the manufacturing process to maintain its definition as “natural”? Take for example a botanical extract, which needs to be extracted first, and then purified, and in some cases needs a preservative to be added to remain stable and safe for the consumer… Furthermore it is important that the message is not passed to the consumers that “natural is safer”: let’s remember that not all what’s natural is harmless. In addition, in many cases it is easier to have a full knowledge of the composition and purity of synthetically produced chemical substances, as compared to naturally derived ingredients; botanical extracts, for example, can vary consistently depending on the part of the plant, alga or macroscopic fungus used for their preparation, or on the geographical location of their habitat, or depending on whether they are cultivated of harvested from the wild.