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In the current context of media attack on antimicrobial preservatives, the cosmetics industry must innovate to continue to develop products devoid of “all” microbiological risks, without any new constraint of use for consumers.
These new products usually combine several technical solutions often combined, which also allow to claim performance in line with new consumer expectations (Without …, Bio … etc). 3 axes are mainly explored: formulations integrating a search for self-protection, protective packaging vis-a-vis of microbial contamination and production procedures that are sometimes almost aseptic. The challenge remains ensuring the microbiological safety of this new generation of products, which often attenuated antimicrobial protection may represent some form of risk-taking, weighed looking for a still acceptable point for the economic balance consumer.
Since the overhaul of the European Regulation (REGULATION (EC) No 1223 / 2009) on cosmetic products, the microbiological quality is seen as part of SECURITY of cosmetic products. The change in the regulation places these elements relating to microbiology in part A of Annex 1 describing the safety report of the product. According to this Annex, microbiological quality must be documented by information on the specifications of the raw materials and the finished product and something new, by the results of preservation challenge testing. In other words, antimicrobial protection is now immediately accessible by consulting the product safety report.
It should be noted that the regulations do not indicate compliance criteria and are content to draw attention to certain product categories with regard to their microbiological quality specifications.
More than ever, the legitimate question is asked as to the acceptable level of microbiological safety for a cosmetic product against a backdrop of more or less justified questioning of the harmlessness of some antimicrobial preservatives. To give an initial response, we must examine the EN-AFNOR-ISO regulatory texts, particularly:
– NF EN ISO 29621 – Guidelines for risk assessment and identification of low microbiological risk products
– NF EN ISO 11930 – Evaluation of the antimicrobial protection of a cosmetic product
– NF EN ISO 17516 – Microbiological limits
This latest standard NF EN ISO 17516 clarifies almost unambiguously the specifications of finished products with regard to the warning of the regulation on certain categories of products, since 2 levels of requirements are planned; on the one hand, an acceptable limit of <1000 CFU / g for topical products and, on the other hand, a reduced limit of <100 CFU / g for products used close to the eye or mucous membranes, or specifically intended for children less than 3 years old. However, there remain the cases mentioned by the regulation of products intended for elderly persons or persons whose immune system is deficient, that it is almost impossible to consider globally by specific criteria. It is also difficult for obvious marketing reasons to segment products specifically intended for “older” people, especially since seniors consume cosmetics in transverse categories and would not necessarily accept to buy products dedicated to 3ème or 4ème age …
As regards antimicrobial protection, after identifying those products whose risk analysis does not allow a conclusion that they are of low microbiological risk (NF EN ISO 29621), resistance criteria are clear if the formula matches profile A of the standard NF EN ISO 11930. According to this standard, compliance with profile A represents an acceptable microbiological safety level of the product throughout its use, under conditions that can be reasonably foreseen.
However, in the context of current media coverage and the recurrent demonization of chemical molecules [among which some preservatives (MIT, phenoxyethanol, parabens, etc.)], the need for less “aggressive” formulation emerges as it often allows support claims considered reassuring for consumers (without .., Bio .., etc.). Thus, new generation formulations without the preservative system described in Annex V of Regulation No. 1223 / 2009 have been developed and are therefore perfectly preserved. This approach, from the conception of the formula, calls upon several combined “galenic” approaches, among which the reduction of the water activity, the use of emollients (multifunctional or not), or the incorporation of certain vitamins with low antimicrobial activity.
This “soft dosage” approach may be insufficient to satisfy the A profile of the standard. It then becomes necessary to use complementary microbiological risk control elements such as those mentioned in the NF EN ISO 11930 standard.
Among these, the protective properties of packaging against microbial contamination then intervene in addition to the antimicrobial system of the formulation, even for those considered “ultra protective”, in total substitution thereof. The question then arises of the confidence for this physical protection with regard to the “no A and no B” profile, and how to confirm this characteristic so as to fully ensure the microbiological safety of the product.
The hermetic properties of packaging then become important not only before opening the product but especially during its actual use. Resistance to retro microbial contamination during a typically long term (months to years) and possibly split represents a new challenge, not only for the cosmetics industry but especially for packaging suppliers.
Initiatives, such as those of the working group of theEvaluation of Microbiological Protection of Packaging (EPMP) of the “Cosmetic Valley” should allow the emergence of fairly standardized methods of evaluating this hermeticity to retro contaminations, to allow a comparison of systems from different suppliers. This characterization will also participate objectively in the microbiological risk analysis of future products, by documenting their rational by analytical data..
The production of formulations that are truly devoid of all antimicrobial activity requires not only packaging that is completely impervious to primary and secondary microbial contamination, but also quasi-sterile industrial conditions. Investment in this type of aseptic production tools then becomes a limiting factor on two levels; capital intensive and also economic, taking into account its impact on the added value of the finished products.
Innovation in the cosmetics sector (or even parapharmaceuticals) is becoming even more crucial in the context of high tension on antimicrobial preservatives and their potential shortage in the medium term. New perspectives are emerging in the respect of security issues in accordance with regulatory and normative references, which justify all the more the development of objective methods of characterization of the dynamic hermeticity of “ultra-protective” packaging vis-à-vis microbiological contamination.
Alain CROZIER – SILAB
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND COUNCIL, of 30 November 2009 relating to cosmetic products (revision)
NF EN ISO 29621 – Guidelines for risk assessment and identification of low microbiological risk products
NF EN ISO 11930 – Evaluation of the antimicrobial protection of a cosmetic product
NF EN ISO 17516 – Microbiological limits
Continue at: https://en.a3p.org/securite-microbiologique-des-produits-cosmetiques-enjeux-et-realites-la-vague-51/