The lowdown on global sunscreen regulation

Geffken believes that there are three primary areas that define what global sunscreen regulation revolves around: testing, labelling and ingredients usage.

“These are areas that have to be addressed because in a global market there are some essential differences in testing, labeling and in the actual ingredients that are being used in the various jurisdictionsm,”  ​said Geffken in an exclusive interview with Cosmetics Design.

“When it comes to sunscreens you have to consider these areas if you want to market sunscreens globally.”​

Though there have been attempts made by various bodies over the years to harmonize sunscreen regulation, Geffken added that harmonization has only been partly accepted by those different jurisdictions, namely Europe, the US and in Asia, where Japan and Australia regulations carry significant clout.

“The ISO standardization process to harmonize sunscreen regulation has only been partially accepted by different jurisdictions, while, to highlight one discrepancy, there are still differing concerns on whether to use in-vivo or in-vitro methodology,” ​said Geffken.

An area of sunscreen labelling often overlooked​

Likewise, Geffken believes that in the complicated labeling equation there is one crucial element that is often overlooked.

“We worry about the specificity of labelling the sunscreen, and yet we often do not stress the concern for the labelling instructions on consumer use.  Often the consumer does not apply enough sunscreen to provide sufficient protection. visavi, the labelled SPF protection value.​

“If someone applies a thin layer or leaves areas exposed, then it can detract from the indicated sunscreen protection formulated into the product. You could purchase an SPF 50+ product but if it is not applied with the right quantity, then there might not be enough to provide the expected level of protection shown on the label.”​

Drug vs cosmetics disctinction​

Another significant consideration involves the different classifications for sunscreens in different global jurisdictions, with the primary difference being that in North America they are regulated as drugs, whereas in Europe they are cosmetics.

“In Europe they are considered cosmetics, but they are still required to test and demonstrate that the sunscreen provides the right protection,”​ said Geffken.

“In the US, the sunscreen must contain a Drug Facts panel, in line with the OTC monograph. This monograph is very prescriptive and includes the sunscreen’s active ingredients and concentration, as well as uses, warnings, inactive ingredients and other information for that product. “​

The language issues​

Compounding the problem of global sunscreen harmonization is the simple issue of language, especially in North America.

On this point Geffken highlighted the situation in Canada, which is officially a bilingual country and requires prominent labelling in both French and English.

“This makes dual labelling very complex and lengthy, and as a consequence drug panels are rarely used in Canada. It would be inappropriate to use both English and French on the same drug facts panel because a dual language drug facts label is not acceptable in the US.​

“And this is precisely why harmonized labelling is such an obstacle, and in fact there is no way to successfully  harmonize a sunscreen label between the US, Canada, Europe and Asia because there is no room on the label for all the languages.​

“Use of sunscreen actives in North American secondary sunscreen products such as lipsticks and face make-up is a further issues due to the extensive labelling mandated on small packages. ​

Changes in drug or cosmetics classification​

In many of the global jurisdictions, the differentiation between cosmetic and drug classification is unlikely to change any time soon, with the exception of Canada, where authorities are currently embracing a potential change under significant industry pressure.

“The Canadian Regulatory regime is much more interested in aligning itself with the European model. Therefore the likelihood of cosmetics verses drug reclassification of sunscreens may eventually happen in Canada, though this is only in the early stages of discussions right now,”​ said Geffken.

“Several years ago, Health Canada reclassified non-theraputic OTC antiperspirants as cosmetics, so there is a mechanism for change. This could also lead to reclassification for other products like anti-acne, skin protectants, and anti-caries toothpaste, all of which are currently classified as drugs in Canada.​

“Lip balms are currently classified as drugs because they are considered skin protectors and also because many contain sunscreens​. The reduced regulatory cost would be a welcomed change in addition to the relief on cumbersome labelling. “

Active pharmaceutical ingredients?​

The third area of focus involves the classification of ingredients, which fall into Active Pharmaceutical Ingredients (APIs) or just simply UV blocking ingredients, depending upon on the market jurisdiction.

“The US list of accepted pharmaceutical actives is limited to those specified in the OTC drug monograph for sunscreens, and US labelling must have those actives and their allowable concentrations designated by their USP drug name. There are additional sunscreens that are allowed in Europe as per Annex VI of the Cosmetic Regulation and these must not be identified as a USP name but by their chemical or INCI name.”​

This situation creates significant differences between some US and European formulation and in an attempt to create more harmony industry has been pressing the FDA to accept some European sunscreen actives on the back of their tried and tested track record, Geffken points out, while also stressing challenges on the European side.

“Conversely zinc oxide has not been allowed in sun care products in Europe as a sunscreen active, although it is allowed in North America, particularly for natural sunscreens, which frequently incorporate titanium dioxide and zinc oxide.​

“The current news on this is that the European regulatory authorities are considering accepting zinc oxide as an active for sunscreens sometime in 2015,”​ he said.

Harmonization has its limits​

“The primary effort behind trying to harmonize as much as possible is for economic reasons, so one formulation can be used in multiple jurisdictions. The cost of OTC drug regulation, labelling and compliance is aligned with dosage form drugs and provides little additional control for sunscreen safety or efficacy.”​

But Geffken also points out that further global harmonization is unlikely due to the differences for the classification of sunscreens in the various jurisdictions.

“It is extremely difficult to foresee authorities in Australia and the US, for example, harmonizing because they are unlikely to ever consider removing the drug classification.  This point was confirmed during recent discussions I have had with the US FDA.”​