Restriction on the use of M-N-MA in Cosmetic Products
The European Commission has published the Commission Regulation (EU) 2022/135. This regulation amends the European Cosmetic Regulation, adding a new entry to Annex III. The use of Methyl-N-methylanthranilate (M-N-MA) in cosmetic products will be subject to restrictions.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

METHYL-N-METHYLANTHRANILATE (M-N-MA)

Methyl-N-methylanthranilate (CAS number: 85-91-6), commonly called M-N-MA, is as fragrance ingredient used in several types of personal care and cosmetic products (e.g. fine fragrances, shampoos, soaps and others). It is also used in other types of products, like household cleaners and detergents.

At the moment, this ingredient is not currently included in the annexes of the European Cosmetics Regulation (No. 1223/2009), which means that its use is not restricted in cosmetic products placed in the European Union (EU).

The European Commission’s Scientific Committee on Consumer Safety (SCCS) has published opinions regarding the safety of M-N-MA use in cosmetic products.

In 2006, the SCCS concluded that M-N-MA was phototoxic, as demonstrated in in vitro and in vivo testing. Moreover, the SCCS stated that this ingredient should not be deliberately added to leave-on cosmetic products, because there is always the potential for light exposure.

Up to a maximum concentration of 0.1%, the use of M-N-MA in leave-on products (including deodorants and antiperspirants) was deemed as safe by the SCCS in 2011. But a risk could not be excluded for the use of this ingredient in sunscreen/sun care products or products (including fragrances) intended for use on areas exposed to light (especially face and neck).

Since M-N-MA is prone to nitrosation, so the SCCS indicated that it should not be used in combination with nitrosating agents and the nitrosamine content should be below 50 μg/kg.

In 2020, the SCCS issued a scientific advice on its last opinion on M-N-MA. The Scientific Committee stated that “Methyl-N-methylanthranilate should not be used in suncreen products and products marketed for exposure to natural/artificial UV light“. On other cosmetic products, SCCS considers M-N-MA safe when used up to 0.1% in leave-on preparations and up to 0.2% in rinse-off products.

UPCOMING AMENDMENT TO COSMETICS REGULATION

The European Commission has published the Commission Regulation (EU) 2022/135, amending the European Cosmetic Regulation ((EC) No 1223/2009) as regards the use of Methyl-N-methylanthranilate in cosmetic products.

Following the SCCS opinions and scientific advice, the Commission considers that “there is a potential risk to human health arising from the use of M-N-MA in sunscreen products and products marketed for exposure to natural or artificial UV light and in other in other cosmetic products where the concentration of the substance is more than 0,1 % for leave-on products and 0,2 % for rinse-off products. Therefore, such use of M-N-MA should be prohibited.“.

Moreover, there is also a potential risk to human health arising from the use of this ingredient with nitrosating agents and the Commission states that such use of M-N-MA should be prohibited.

An entry will be added to Annex III (list of substances which cosmetic products must not contain except subject to the restrictions laid down) of the EU Cosmetic Regulation, restricting the use of M-N-MA.

Reasonable periods of time will be granted to the industry in order to make the necessary adjustments to product formulations and comply with new requirements and withdraw cosmetic products which do not comply with those requirements.

The European Cosmetics Regulation is considered one of the most complex in the world and being up to date can be a hard task. Critical Catalyst is here to help you. Feel free to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Commission Regulation (EU) 2022/135 of 31 January 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Methyl-N-methylanthranilate in cosmetic products.

further
reading

cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »
medical devices

EUDAMED – harmonized practices and alternative solutions for IVDR until the database is fully functional

EUDAMED is one of the key aspects of the new rules on in vitro diagnostic medical devices – Regulation (EU) 2017/746. However, it is only expected to achieve full functionality by the second quarter of 2024. Until then, how is the information submitted and/or exchanged between manufacturers, notified bodies and competent authorities?

Read More »
medical devices

EUDAMED – update on timelines

EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), and it is expected to achieve full functionality by the second quarter of 2024.

Read More »
cosmetic products

UK OPSS call for data on six cosmetic ingredients

On 14 July 2022, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued a call for data on the safety of the following six cosmetic ingredients to investigate any suspected endocrine disrupting properties. 

Read More »
cosmetic products

European Commission Recommendation on the Definition of Nanomaterial

Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. The European Commission has published a new Recommendation to clarify the definition of ‘nanomaterial’. This definition may serve different policy, legislative and research purposes when addressing materials or issues concerning products of nanotechnologies.

Read More »
cosmetic products

Expected Restriction on the Use of Methyl Salicylate

The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Annex III to Regulation will be amended, and the use of Methyl Salicylate in cosmetic products will be restricted.

Read More »