The same as any other cosmetics. This is because only the maximum composition of certain types of constituent substances is defined in the framework formulas.
Only the composition can be deduced from the frame formulae. Under no circumstances do they provide the other safety data required in Annex I, Part A of the Regulation. This includes physico-chemical properties, stability, impurities, toxicological profile of the components, application methods, etc.
Since a given frame formulation allows for a large number of different compositions, each of them will have a specific toxicological profile. It will therefore require individual treatment.
Framework formulations in Regulation 1223/2009 on cosmetic products:
The Cosmetics Regulation refers to the framework formulae in the following articles:
- In Article 2, a frame formula is defined as: “a formulation listing the category or function of ingredients and their maximum concentration in the cosmetic product or providing relevant quantitative and qualitative information in cases where a cosmetic product is not or only partially covered by this formulation. The Commission shall provide indications for the establishment of the framework formula and shall regularly adapt them to scientific and technical progress”.
- In Article 13, which refers to the information to be submitted to the Commission before the cosmetic product is placed on the market. Paragraph H states: “the framework formula allowing rapid and appropriate medical treatment in the event of difficulties”.
Framework formulations and toxicological information
Framework formulas were defined for the safety of cosmetic products. But not to ensure their safe use, but to be able to apply the appropriate medical treatment in the event of an accident due to misuse. An example of this could be accidental ingestion by a child. The frame formulas were therefore created for the Poisons Information Centres, which have them on record. In this way, a cosmetic can be quickly identified and appropriate treatment proposed for any incident or accident. In an emergency, it is logical to start from a maximum situation, i.e. a worst-case scenario.
A framework formula should not be innocuous. In fact, if it is formulated with the maximums indicated we would obtain, from the point of view of potential harmfulness, cosmetics that would not be optimal. For example, let us take the frame formula of a «Skin Gel» containing: 40% ethanol, 20% propylene glycol, 10% vitamins and plant extracts, 6% non-ionic surfactants, 3, 5% parabens, 2% carbomer, 1% dye, 0’5% perfume and water up to 100%. It is clear that it would meet the framework formula requirements. However, this formula is not the optimum formula that a formulator would propose for a skin gel. With such a formula, more precautions should be taken than with other skin gels. As long as they have the amounts of their components more closely adjusted.
The components of the framework formulae
Another consideration is that in the frame formulas, in general, the components are not precisely indicated. Rather, reference is made to groups of substances, citing a few examples, defined by their activity. Thus, for example, in the frame formula for “Skin cream, including moisturising cream”, the maximum concentrations of: “silicones and volatile silicones (e.g. cyclomethicone), emollients (oils, waxes, etc.), moisturising oils (e.g. glycerine) and fillers (starch, kaolin, talc, etc.)” are quoted. As can be seen, in no case is the specific component given.
It should be stressed that the formulation of a cosmetic is not the only safety factor foreseen in Section I, Part A. In fact, other factors such as impurities, chemical, galenic and microbiological stability, or application conditions are also very important. All these factors are not covered by the framework formulae, which only indicate maximum acceptable levels for certain types of components. For example, the regulations tell us that we can prepare a hand cream with 25% of fatty esters. It does not say how much, nor what kind of impurities must be taken into account. Lipoperoxidation, for example, is not considered in this case.
Conclusions
Therefore, if we compare the requirements of a frame formulation and the safety data provided for in Annex I, Part A, it is clear that a frame formulation must follow exactly the same procedure as any other formulation we develop for marketing.
Framework formulas are therefore useful for effective intervention in the event of misuse leading to an accident. They even allow for a certain degree of confidentiality, as the formula does not have to be declared under certain conditions. But in no case do they have a special treatment, given the need to provide all the data required by the Regulation to ensure the safe use of a cosmetic product.
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- The Expert opinion was written in 2012 for the former GTF M. Camps website. And it coincided with a context of doubts regarding the interpretation of Regulation (EC) No 1223/2009 on cosmetic products. Today, these issues are still of great relevance for the cosmetics sector.