Regulatory compliance is a never-ending process

Although the paradigm of static regulations established once and for all never existed, it is obvious to all that regulatory developments have never been so fast. This observation is particularly true in Europe where a special importance is given to the protection of public interest and for the cosmetic sector where cost-benefit balance does not apply [1].

Mere compliance with the EU Cosmetics Regulation (EC) N°1223/2009 is not enough. Amendments are published several times a year in the Official Journal of the EU and one should not undervalue the amount of work needed to estimate what is going to be published and when. Needless to say that the same things happen to other pieces of legislation published by the EU Commission or self-regulatory organizations: adaptation to technical progress (ATP) of the CLP Regulation (EC) 1272 / 2008, IFRA amendments, Commission Decisions on Ecolabels, Regulations on ethanol denaturation, etc. The International and European legal texts that can affect a cosmetic manufacturer are countless. One might already think that this is a tough job but this is not all: the transition periods to implement new legal requirements are usually very short and cosmetic reformulations in hurry are the best way to waste a lot of money and, quite often, a significant fraction of loyal customers. Proactivity should, therefore, always be preferred to reactivity!

However, all cosmetics manufacturers are not necessarily great regulatory specialists and selecting a well-trained external regulatory expert may be more efficient than allocating insufficient resources to in-house regulatory monitoring.

Preservatives are useful!

As far as regulatory compliance and consumer safety are concerned, preservatives are a major issue in the cosmetics Industry. Most cosmetic products need to be protected from microorganisms and this is why preservatives are so incredibly useful. A standard face cream formulated without preservative and simply exposed to air would quickly get contaminated and become dangerous for the consumer within a few weeks or even a few days.

However, consumers tend to favour products claiming not to contain preservatives and distrust products containing specific ones such as Methylparaben. I will not address the why and how of this situation as this topic is more related to marketing than science or regulatory affairs.

Of course, some categories of cosmetic products do not need to be preserved simply because microorganisms are not fond of them. This is typically the case of products with a high alcohol content (at least 15-20%), products based on organic solvents, high/low-pH products and low water content products. However, most of the cosmetic products would just be gourmet treats for bacteria if preservatives did not efficiently protect them.

Shrinking list

Despite their usefulness, many preservatives are now at risk because of toxicological properties pointed out by the Scientific Committee on Consumer Safety [2]: endocrine disruption, carcinogenicity, mutagenicity, reprotoxicity, skin sensitization - the list of safety concerns raised is almost endless. The list of allowed preservatives (reported in Annex V of the EU Cosmetics Regulation EC No 1223/2009) is constantly shrinking and almost nothing comes to replace removed substances.

Three workarounds can be considered: do with what you have (easier to say than to do), rethink your packaging to include technological solutions (e.g. airless dispensers, single-use products) and use non-official preservatives recognized for other functions (essential oils, alcohol, etc.).

But, before thinking about alternatives, let’s try to understand what is going on with preservatives. I will address the complex issue of Methylisothiazolinone here below and will focus on other preservatives (and notably on Article 15 of the EU Cosmetics Regulation) in my next article.


Methylisothiazolinone (MIT) is a very efficient preservative, which had a huge (but short) success when the use of Methylparaben became less and less popular. The problem is that, beyond its antimicrobial properties, MIT is also a strong skin sensitizer that caused an unprecedented skin allergy outbreak in Europe over the last years. The EU Commission had to promptly react to this public health issue but, given the expected economic impact on the cosmetics industry, also had to adopt a stepwise approach.

First, they started to focus on the Methylchloroisothiazolinone (MCI) and Methylisothiazolinone (MIT) mixture, regulated in the EU Cosmetics Regulation by entry 39 of Annex V (at 15 ppm in a ratio 3:1). After consultation of the SCCS, the Commission banned this mixture in all leave-on cosmetic products (EU No 1003/2014) with a pretty long transition period. This transition period is currently coming to an end and from April 16th, 2016, only cosmetic products complying with this piece of legislation shall be made available on the EU market. The use of this mixture in rinse-off products was not impacted.

In a second step, the Standing Committee on Cosmetic Products [3] of the EU Commission voted to ban of MIT alone, when used in leave-on cosmetic products (including hair leave-on products). The substance being extensively used in the industry, and currently restricted at 100 ppm (0.01%) in all cosmetic products (via entry 57 of Annex V), we could have thought that this ban would come with comfortable transition periods to allow the industry to make the necessary adjustments to product formulations but this does not seem the case. This amendment expected from one day to the other will get enforced 20 days after its publication and then a six-month transition period will start. At the end of this period, only cosmetic products complying with the new regulation shall be placed and made available on the EU market.

Finally, the SCCS released a last Scientific Opinion on MIT recommending that MIT be further restricted in rinse-off products from the current 100 ppm to only 15 ppm (0.015%). The EU Commission took these recommendations on board and released a regulatory proposal reflecting the SCCS Opinion. In addition to this severe restriction, the warning “Contains Methylisothiazolinone” will probably have to be labelled. Although MIT is not effective at such a low concentration, the industry made a point of preserving a limited use of this ingredient since many raw materials are preserved with MIT (which is therefore frequently present below 10 ppm in the finished product). Currently under public consultation, this regulatory proposal should be submitted for vote at the Standing Committee in early 2017. Once voted, we can reasonably expect 3 to 6 months for the EU Commission to prepare and publish the corresponding regulation. Twenty days after the publication of this piece of legislation will start the transition period, which should be 6 months for placing on the market and 9 months for withdrawing from the market.

I would therefore recommend to start immediately the reformulation of your leave-on products (if not done already) and check that your raw materials suppliers are aware of this upcoming changes and ready to provide you with MIT-free alternatives.