The Cosmetics Regulation requires a more thorough report on product safety. This report already existed in the Directive. However, its content shall be enriched and will be more complex, while the workload and the methods used by the safety assessor will dramatically increase. Hence, a need to define again the role of the assessor, with a view to the implementation of the Regulation, on 11 July 2013. Here is the opinion of Philippe Masson, toxicologist, biologist, EVIC France CEO, and of Clarisse Bavoux, toxicologist, pharmacist at Evic. Both they are safety assessors.
Who is a safety assessor?
“A priori, it is a person known as competent in toxicology who is to evaluate the safety of use of the cosmetic products available to the consumers,” Philippe Masson sums up. In the Regulation, the product safety report (Annex I) comprises two parts: “Part A," which displays the cosmetic product safety information data, and “Part B," dealing more directly with the safety assessment of these data.
This refers to the Article 2 of the Directive, “Cosmetic products (…) must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use (…). The assessor’s role, then, is to say, “OK, I give the ‘go-ahead’ signal, or not,” Philippe Masson reminds us.
He or she can be a salary-person, or an outside consultant, but shall be independent of the production and management departments in the company. “Outside assessors may be considered as more reliable; this is not always true. It depends on the expertise of the internal toxicologists. In fact, it does not matter, as far as competence and independence are for real,” Philippe Masson explains. He puts at circa fifty the current number of outside assessors in France.
The Directive was already clear about the needed qualifications: a diploma “in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline” (Article 7 bis, e).
The Regulation uses the same principle, while letting some space to a recognized expertise (Article 10.2). “It happened that the [French] Administration (The General Directorate for Health - DGS - or the formerly Afssaps - now ANSM) did not recognize the applications of people who have not demonstrated their ability for this mission,” the toxicologist comments. He has performed safety assessments since 1976.
The assessor, in fact, looks for the “acceptable risk," as there is no “zero risk," neither a perfect innocuousness. “By definition, any substance has an intrinsic danger. The question that the assessor must ask is as simple as: is this potential danger likely to appear or not under the conditions of use of this substance in the product when placed on the market?” Philippe Masson explains. And this is where the expertise is weightier than a bookish knowledge …
Risk and danger
Any toxicologist has in mind the fundamental difference between risk and danger: “The danger is directly linked to the intrinsic harmful properties of a substance (systemic effect, for instance, with a digestive or blood-related, or neurological, or any other kind of impact). Any substance is potentially dangerous (absolute danger). The risk, on the other hand, is measured by the possibility that the danger materializes, depending on the exposure (the use).”
In the cosmetic world, only risk is taken under consideration. Due to the impossibility to control the real conditions of use of the products, one must go further and make sure that a safety margin is preserved against this potential risk (Directive, Article 2.)
As an example: the safety evaluation of a shampoo in a “Mickey” bottle, which attracts children, shall include not only the risk of using the shampoo itself, but also the risk of an accidental ingestion.
The steps of an evaluation
Here is how Philippe Masson works.
“1/ I use all the documents the manufacturer made available to me: the product formula, data on the raw materials (RM), how the product will be used (diluted or not, for instance), manufacturing process, packaging characteristics, etc. This, to answer the questions: What is this product? Who are the likely users? How will it be used?
2/ As for the formula, I check its compliance with the Regulation, and the aggravating risk factors that may be due to the blend of the raw materials. Here, expertise is a major advantage.
3/ When a piece of information on a substance is lacking, I ask the manufacturer for the Material Safety Data Sheets (MSDS). The manufacturer can get them from its suppliers. Quite often, at this step, I see that much data are missing. Then, I have to go to my own data base.
4/ For the finished product: I check the Good Manufacturing Practices (GMP), without always going to the production site, if we have had a long relationship with the client along with a mutual trust. I also check what has been done to evaluate the safety of the end-product.
Depending on whether it is a brand-new formula or an adaptation of an existing one (then, I use similarities), my demands vary: if changes are minor on an already marketed formula, the existing data may be enough; if major changes are made, I could ask for additional tests.
5/ I have a motto: tests are not mandatory, but I have to ask for them if it is justified, without requiring the tests be performed in my own research center. Sometimes, the manufacturers have their products tested elsewhere, and come to ask for our opinion.
I do this to prevent manufacturers from thinking that we are overcharging them with complementary tests."
Two practical examples
Clarisse Bavoux, a toxicologist and pharmacist at EVIC, gives us two emblematic cases: a hair dye and a day cream.
1/ The hair dye
“In this case, the number of potentially harmful ingredients is impressive, but the risk is managed, thanks to the restrictions for use (in terms of concentrations) and the normal conditions of use for this kind of product, which are especially well controlled. For instance, if it is a product for the public at large: it is used once a month, as a single dose, etc. On the other hand, the situation is far different for a professional product: daily use, higher quantities, etc. The French National Institute for Research and Safety for the prevention of occupational accidents and diseases, INRS, as per its French acronym, has issued very useful documents designed for professionals and occupational physicians”. The safety point of view is vastly different, depending on the case.
2/ The moisturizing day cream
“In general, this kind of product does not lead to any skin tolerance problem. However, a good knowledge of the toxicological profile of each ingredient is essential: as, quite often, the raw materials have been used for a long time, they are supposed to be well known…This is true, but the Regulation makes it mandatory to describe the toxicological profiles of all the ingredients (as required in the Part A of the report), when, for many of these raw materials, the profiles are mainly unknown, even by the suppliers.”
According to Philippe Masson, the prices currently seen on the market for the safety assessment of a product in full compliance with the Regulation requirements are comprised between 180 € and 800 € (240 to 1 000 USD; 135 to 600 BP). That means, in his opinion, the assessors do not have the least idea of the real burden of the job they have now to supply! Indeed, when two hours were enough when working with the Directive requirements, up to two days may be needed to comply with the Regulation…
“The Regulation implies to formalize every step, when the Directive required only an overall assessment,” Clarisse Bavoux explains. “In fact, it is a new way of thinking: previously, a person had the responsibility of the assessment and endorsed the product safety. Now, a report (data + evaluation + conclusion) shall be established, in which everything shall be written, hence, justified. This is a positive step as it forces the assessor to ask more questions: The Annex 1 gives some elements; they do not all have the same importance, but all the questions must be asked.”
As a result: when the Certificate (after the Directive) was some pages-long only, the report (as per the Regulation) comprises ten to twenty pages …
The evaluation purpose
“A safety assessment is not designed to meet the regulatory requirements, but really designed to meet the consumers' safety concerns: a green rubber-stamp is not enough! The assessor shall think of the downstream user. The chronology is very important: the opinion of the assessor shall be required on time, because, if it is negative when the development of the product is finalized, the economic, even financial, consequences may be dramatic …” Philippe Masson warns. A current situation in SMEs, which do not have internal safety specialists and are often late to seek the outside assessor’s help, having their back up against the wall just when launching their product …
Clarisse Bavoux reminds that, when talking about “normal or reasonably foreseeable conditions of use,” one must keep in mind the safety of the average consumer (who, obviously, has not been trained in cosmetology), while using common sense (not using a product designed for oily skins on a dry skin.)
A half-way situation
While the Directive is still applicable, and the Regulation will be fully mandatory in July 2013, manufacturers are currently in a transitional period.
“We begin to see SMEs looking at the Regulation,” Philippe Masson says. “Indeed, the industry is not yet ready to apply it: the main problem is that the safety data available to the cosmetics manufacturers, as those available to their raw materials suppliers, are manifestly incomplete …That is why we are developing a huge data base on ingredients to fill in these gaps. Impurities (in a raw material) are a good example: there are impressive differences between suppliers. It is sometimes difficult to get data the quantity and the quality of which may depend on the customer’s size: the supplier accepts to invest (to supply the data) when he hopes for a good return on its investment,” the toxicologist explains.
Nevertheless, the manufacturer also has its role, as Clarisse Bavoux shows, “The lack of data by suppliers may sometimes be balanced by data on the finished product (for instance: impurities). One must think about the points to check, and everyone has to take their responsibilities. In this case, the manufacturer must control its finished product, as it is what the consumer uses, and not its ingredients. The safety assessment is designed for that purpose, and not to answer the Regulation requirements: this is the reasoning to follow (Part B of the safety report).”
The consequences on the RM catalogue
“Due to REACH and the Cosmetics Regulation, the disappearance of some raw materials is unavoidable,” Philippe Masson warns. “In fact, it is a pity from a toxicological point of view, as this will have adverse consequences, especially in the contact allergies area. The preservatives' example is self-explaining: the more are banned, the worse it is - as, mechanically, the exposure to those that are still allowed increases (as far as the concerned substances are of low toxicity). The questioning of parabens is typical: there is no scientific base, and it is only the consequence of a media hype that the cosmetics industry has been unable, or did not want, to fight.”
The challenges to match
Can we say there will be a lack of safety assessors? “Yes! In addition, an assessor needs analysis means. As animal testing is to be totally banned (in March 2013), there is a need to combine the skills of a chemist, a physicist, a formulator, a physiologist, a toxicologist, a clinician …while having some expertise in cosmetics! The worst: it seems nobody is concerned. While, previously, the experimental toxicology was performed through a global toxicological approach, one must now assess the toxicological risk from the mechanisms of action, a far more arduous way,” in Philippe Masson’s opinion.
Clarisse Bavoux gives additional explanations: “Animal testing is a tool that will disappear, a contradictory situation. Indeed, for a better image and so-called ethical reasons, it is banned, while the text of the Regulation (very stringent) implies a far more thorough safety assessment (a positive point). Therefore, there are fewer available tests against a growing request for more data. Indeed, alternative methods are not available for everything, by far: especially, validated tests are not all applicable to finished products.”
In short, the requirements of the Regulation in terms of the safety assessment of a cosmetic product are both a hard job and true scientific challenges that cannot be answered by just a regulatory document.