And finally (honestly!) . . . .

Having reported on the SCCS Final Opinion on parabens, I had decided that I would call it a day on writing articles on this subject. However, Part 7 provoked an unusually lively discussion, with some interesting points being highlighted, and I have addressed these points by extending the series with another 3 articles. This really is the last one!

I had been massively overoptimistic in my hope (assumption?) that the SCCS Final Opinion would be more readily accepted, and that made me a little lazy in what was intended to be my final article, and I realise that I should have included more detail for clarification of the decision.

As a side issue, I will also address the accusation that the SCCS are easily swayed by the cosmetics industry. It is difficult to prove anything here by quoting references, so you will just have to take my word for the fact that the SCCS are fiercely independent of industry. The only supporting documentation I can offer is the SCCS Final Opinion itself, in which the transparency with which the decision is discussed should make it reasonably clear that the SCCS does not accept much of what industry proposed! So, perhaps we can put the “vested interest” argument firmly in its place (the bin!).

There seems to be some confusion over the relevance of the maximum permitted concentration, with a perception (in some quarters) that this may be a magic cut-off point, and concentrations above this figure suddenly become harmful. This is far from the case, and I will explain here, how the SCCS arrive at their figure for the maximum permitted concentration.

The entire process of the SCCS decision making is, essentially, a risk assessment. The ultimate aim of the Committee is to determine the lowest observed adverse effect level (LOAEL) from across ALL the relevant studies, and use this figure in a calculation to ensure a margin of safety (MoS) of AT LEAST 100. Other data points required are the total exposure to the substances in cosmetics, and the amount of absorption through the skin.

The figures used by the SCCS in their calculation were as follows:

Exposure to cosmetics – 17.79g/day (a figure generated by extensive research into consumer use)

LOAEL – 2mg/kg bodyweight/day (the lowest figure obtained across all the studies considered)

Dermal absorption – 3.5% (the SCCS were not completely happy with the amount of data available, and so used a figure that was higher than they anticipate being the true value in order to err on the side of caution)

Maximum permitted concentration – 0.4% (the current maximum was used in the initial calculation to determine the MoS based on the current regulatory position)

These data were then entered into the equation, producing a MoS of 48 (I emphasize that this was based on the existing maximum permitted concentration). As the SCCS are required to ensure a MoS of at least 100, they calculated that a new maximum concentration of 0.19%, based on the above data would achieve the desired MoS of 100.

I hope that this process is clear.

What the new maximum concentration does NOT mean is that:

1)      The old maximum concentration was unsafe

2)      Any product containing more than 0.19% in total of propylparaben and butylparaben is now unsafe

There is a MARGIN OF SAFETY of 100 times the new maximum permitted concentration!

This, in theory, means that it is sufficiently safe to apply 17.79g (0.63oz)of cosmetic products containing up to 19% daily (yes, 19 – not 0.19%, although this could well result in skin irritation) or, conversely, it is sufficiently safe to use up to 1779g (1.779kg – 3.9 pounds) of cosmetic products DAILY containing 0.19% total propylparaben and butylparaben. I am not recommending either scenario, as both are clearly impossible, but I am trying to emphasize the point about the margin of safety.

As was clearly explained by another contributor in one of the comments on an earlier article, this opinion represents the current state of knowledge on parabens. If any further information is generated that would have an impact on the MoS calculation, the SCCS will be required to reconsider their opinion. Until that event, parabens may be considered to be safe for use at up to the following maximum concentrations:

Methylparaben – 0.4%

Ethylparaben – 0.4%

Propylparaben + butylparaben combined – 0.19%

Total parabens (ie. all of the above) – 0.8%

Just for the record, methylparaben is NEVER used at 0.4%; ethylparaben is NEVER used at 0.4% – they are not sufficiently soluble to permit such high concentrations in most systems, and the total parabens concentration is unlikely ever to exceed 0.5% in the vast majority (>99%) of cosmetic products because, basically, if you require such concentrations, there is probably an incompatibility with other ingredients, and a totally different preservation system should be considered.

AUTHOR’S NOTE

This really is my final article on parabens and I do not intend to engage in any discussion on this post for the following reasons:

1)      If you disagree with the SCCS decision, tell them – not me, it wasn’t my decision

2)      If you disagree, then you think you know better than the SCCS, tell them – not me, I DON’T know better than the SCCS.

3)      There will always be those for whom no amount of information is sufficient, and they will always demand more. I have no desire to discuss this, because the SCCS were sufficiently satisfied to make a firm decision. Given that there are probably more data available on parabens than for the vast majority of other cosmetic ingredients, they should, perhaps, focus their efforts on demanding that data gaps be filled for some of these other ingredients, especially those of natural origin.

4)      I am tired and I need a break – I think I deserve one!

I reserve the right to change my mind, especially if someone corrects me incorrectly! If I am proved truly wrong about any aspect of this article, I will accept the correction without response.

Author

Dene Godfrey has been involved with preservatives for cosmetics since 1981, from both technical and commercial angles and has a degree in chemistry. Dene worked for one of the largest manufacturers of parabens from 1992 – 2002, and currently works for a UK company involved in the distribution of ingredients for cosmetics, health care and food. The Boots Company, 1973 – 92, Dene spent 11 years working with bronopol, although he was also involved in the initial development of Myavert C, now known as Biovert – a well-known “non-preservative”. Latterly was responsible (as Technical Manager) for the operation of the Formulation Laboratory and the Microbiology Laboratory. As Technical Manager when at Nipa Laboratories, Dene was responsible for development and sales of new preservative products, mainly into personal care. Developed the Nipaguard range of preservatives and co-patented a preservative system based on phenoxyethanol and IPBC. In 2002, Dene founded MGS MicroPure (as Technical & Sales Director) to compete with the giants of preservation, establishing the Paratexin brand name in the UK and several other markets (EU/ global). MGS MicroPure ceased trading in 2005. Since 2005, Dene has been employed by a major UK distributor of personal care ingredients, with his focus primarily on preservation systems. Dene’s articles are based solely on his personal opinions, observations and research, and are not intended to represent any official position of the part of his employer. Dene obtained a BSc (Hons) in Chemistry from the Open University in 1996. He also obtained the Professional Certificate in Management from the Open University in 1997. He has been an active member of the UK Society of Cosmetic Scientists since 1992, and has served 4 terms on the SCS Council, and is involved with the SCS Social Committee from 1993 to date; from 2004 – 7 as Social Secretary. Dene has presented papers at many SCS meetings and was President of the SCS (2009/10)

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