Upcoming Ban of Lilial (Butylphenyl Methylpropional)

October 17th, 2019

Lilial, also called Butylphenyl Methylpropional (CAS 80-54-6) is an important fragrance ingredient commonly found in cosmetic products. This is also an ingredient well-known from cosmetic brands since it is one of the 26 official fragrance allergens that have to be reported in cosmetics’ lists of ingredients.

End of 2017, a classification proposal was submitted to ECHA via a regular CLH dossier and the proposal was Repr.2 (Reproductive Toxicity class 2). By default, CMR substances cannot be used in cosmetic products and IFRA (the International Fragrance Association) submitted a safety dossier to the SCCS in view to get an exemption. The Scientific Opinion released by the SCCS was negative and IFRA resubmitted a new dossier with lower use concentrations. Again, the second Scientific Opinion was negative despite the conclusions let understand that safe levels could be derived for Lilial.

Unfortunately, the ECHA Risk Assessment Committee (RAC) evaluated the classification proposal in parallel and concluded that Lilial should rather get classified Repr. 1B, which is a much more severe and conservative decision. The classification has been legally adopted on June 16th, 2019 and should lead to an amendment of the CLP Regulation once the European Commission has approved it. Such an approval by the European Commission is expected to take place.

Actions need to be taken since this classification will automatically lead to a ban of Lilial in all cosmetic products. Indeed, the SCCS will not validate an exemption now that the ingredient is classified Repr. 1B. BIORIUS estimates that the ban will be adopted during the first semester of 2021. It will take the form of an Omnibus Regulation, which will immediately start to apply once published (as it happened for Omnibus Regulation 2018 and will happen soon for Omnibus Regulation 2019). By this time, all products should be reformulated to remove Lilial and product labels should be corrected if Lilial appears on the lists of ingredients.

The problem of Butylphenyl methylpropional (also called BMHCA and Lilial)

October 13th, 2015

Biorius received a lot of questions about Butylphenyl methylpropional (also called BMHCA and Lilial, CAS 80-54-6) and you are all concerned by the future of this useful fragrance ingredient. We would like to clarify the situation and show you the potential perspectives for this ingredient, although it is still highly speculative to make declarations on how this issue will get resolved.

What are we talking about?

As you may know already, the Scientific Opinion SCCS/1540/14 on BMHCA is currently open for comment and the public consultation will end on November 10th, 2015. It is noteworthy that this Opinion does not focus on the skin sensitization properties of BMHCA (which are addressed in the Scientific Opinion SCCS/1459/11) but on its reproductive toxicity. The ongoing regulatory developments on fragrance allergens are also expected to impact the cosmetic use of BMHCA but this is not the topic of this article.

Reproductive toxicity (REP) is one of the CMR endpoints regulated by Article 15 of the EU Cosmetics Regulation. As explained in the Biorius Newsletter of February 2015, the unusual mechanism of Article 15 foreseesthe automatic ban of cosmetic ingredients at the time when their official CMR classification gets implemented via an ATP (Adaptation to the Technical Progress) of the CLP regulation.

Background

Two years ago, BASF registered its intention to submit a dossier to ECHA (the European Chemical Agency) in June 2016. As foreseen by the REACH regulation, this dossier (called CLH dossier) will formally notify the Authorities that BMHCA has been identified as a reprotoxic material and needs to be further evaluated. This means that, in June 2016, the classification process of this ingredient will start. This process is expected to end up with the classification of BMHCA as a REP2 material.

To avoid an automatic ban of the ingredient, IFRA (International Fragrance Association) proactively submitted a safety dossier to the SCCS in order to support the safe use of the ingredient despite its CMR classification. Alas, two versions of this dossier did not suffice to convince the SCCS, which continues to consider BMHCA as unsafe and refuses to deliver a positive Opinion.

What is going to happen next?

It is difficult to determine at this stage what is going to happen and two scenarios can be envisaged:

• IFRA re-challenges the SCCS (via the public consultation or a third version of the dossier) and manages to get a positive Opinion. Then, the ingredient will not be banned and specific use restrictions (potentially the ones proposed by IFRA) will get implemented. The implementation date is difficult to forecast but will take place before the official CMR classification gets implemented.
• IFRA does not re-challenge the SCCS (unlikely) or does not manage to get a positive Opinion at the proposed concentrations (possible). Then, lower concentrations can be proposed or, in the worst case, the SCCS stays on its position that BMHCA is unsafe. In this case, the SCCS does not deliver a positive Opinion on BMHCA, the automatic ban procedure will then continue until its conclusion, which is estimated to occur in June 2018.

Biorius believes that it is too early to take a business decision related to BMHCA-containing cosmetic products but wanted to raise your awareness of this issue. We will continue to inform you about this topic as more information becomes available.