EU Regulatory Update: CTPA's Take on Claims and Cannabis

The world of personal care regulations is ever-changing. Fittingly, the first installment of the Cosmetic, Toiletry and Perfumery Association (CTPA)’s column in 2019 zooms in on new developments in cosmetic claims and cannabis for a closer look.

Cosmetic Claims

In the past, the CTPA column has addressed cosmetic claims; in particular the European Union (EU) Regulation on Common Criteria for Cosmetic Claims (655/2013), and the European Commission’s (EC) report on Article 20 of the EU Cosmetics Regulation in relation to the common criteria for cosmetic claims, which raised concerns over free-from and hypoallergenic claims. The EC Technical Document on Cosmetic Product Claims was updated in July 2017 to include Annexes that address claims of the free-from nature (Annex III) and the claim hypoallergenic (Annex IV). Annexes I and II (published in 2013) are already being applied, and the new elements of the EC guidance included in Annexes III and IV are applicable as of July 1, 2019.

While the document is not legally binding, companies must be mindful that it states an implementation date and reflects a common understanding of EU national competent authorities; several of which have already indicated their intention to apply the guidance in the document.

In order to help companies to understand the EC Technical Document on cosmetic claims, CTPA has created a Help Note on free-from claims. The Help Note reviews how the Common Criteria for cosmetic claims (i.e., Legal Compliance, Truthfulness, Evidential Support, Honesty, Fairness and Informed Decision-making) apply to these claims. The Help Note also highlights how the Technical Document is expected to be implemented in different EU Member States based on a Cosmetics Europe—the European personal care association—survey in 2018. This Help Note is available on the CTPA public website^a.

In light of the EC Technical Document’s impending implementation this year, and to include other relevant updates, CTPA has also refreshed and relaunched its Guide to Advertising Claims. This CTPA Guide is an updated version of the first release in 2008. The Guide is still divided into three main parts, explaining: the regulatory framework, the building blocks of claims support, and providing a guide to good study design.

Key new features include:

• Updated references

-Medicines Healthcare products Regulatory Agency (MHRA) Guidance Note 8

-Cosmetics Regulation

-Common Criteria on Cosmetic Claims

-Technical Document on Cosmetic Claims

-Committee of Advertising Practice (CAP) Note on the Use of Post-production Techniques

-ISO 16128 (Part 1 and 2)

• Focus on the role of Responsible Person
• Updated views of the Committee of Advertising Practice (CAP), Advertising Standards Authority (ASA) and Clearcast
• Decision tree and case studies for practical understanding.

The Guide is endorsed by the U.K. advertising authorities: CAP, ASA and Clearcast.

Of course, cosmetic claims must not mislead the consumer, and, crucially, companies should consider the consumer’s perception and use of a product, as that will also determine the classification of a product.

Cosmetic claims must not mislead the consumer. It is crucial for companies to consider the consumer’s perception and use of a product.

Cannabis and Cannabidiol

Cosmetics & Toiletries has highlighted the rise in popularity of consumer products based on cannabinoids and recently reported on the debate at the 72nd Annual Scientific Meeting & Technology Showcase, presented by the Society of Cosmetic Chemists. It would perhaps be useful, then, to explain the situation in the U.K. with regard to cannabis-based ingredients and cosmetic products, as there seems to be some confusion.

For cannabidiol (CBD) oil, the EU Cosmetics Regulation prohibits the use of narcotics in cosmetic products, Annex II entry no. 306:¹

"Narcotics, natural and synthetic: All substances listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March, 1961."

Schedule (Table) 1 of the 1961 Convention lists "Cannabis and Cannabis Resin—and extracts and tinctures of cannabis.”

The definitions given in the Convention are:²

• "Cannabis" means the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated;
• "Cannabis plant" means any plant of the genus Cannabis; and
• "Cannabis resin" means the separated resin whether crude or purified, obtained from the cannabis plant.

Cannabidiol is not itself a controlled drug (in the U.K.) but could be in scope of the above ban based on the plant part source. It is therefore extremely important to establish more information about the processing and plant (+ part) from which the material is derived. Absence of controlled substances, as regulated under the UK Misuse of Drugs Act (MDA) 1971, within the CBD oil is also essential.

However, there is further confusion as all entries in the European Commission CosIng database that relate to cannabis have been marked as banned, which is not necessarily correct.

For hemp seed oil, this has been used for a number of years in cosmetics and is obtained from the industrial varieties of cannabis that can be legally grown in the EU/U.K. The seed oil is permitted for use (despite the recent incorrect entry in the CosIng database) via the horizontal link between the EU Cosmetics Regulation and the International Convention on Narcotics. The definitions above are also applicable here.

CTPA is in discussions with the U.K. authorities—the Department for Business, Energy and Industrial Strategy (BEIS), and the Home Office and Trading Standards—and is in the process of finalizing a position paper on this topic, which will be available on the CTPA public website.

Importantly, cosmetic products containing cannabis extracts must adhere to the legal definition of a cosmetic product where the products are to be supplied, both in application route and function, and that any claims must be cosmetic in nature.

CTPA Update

On a final note, Chris Flower, Ph.D., who has written a CTPA column for Cosmetics & Toiletries with myself for the past few years, retired at the end of 2018. Chris, a toxicologist and Chartered Biologist, had been at CTPA for 22 years; the last 15 of those in the role of director-general. Chris is extremely proud to have had the opportunity to champion the cosmetic and personal care industry for more than two decades and has enjoyed writing for Cosmetics & Toiletries. I am incredibly honored to be the new director-general of CTPA and to represent an industry that is so vibrant and dynamic, while being rooted in sound science and robust safety measures.

On behalf of Chris and myself, may I wish Cosmetics & Toiletries and its readers a successful 2019.

References

1. (2019, Jan. 10). Annex II: List of Substances Prohibited in Cosmetic Products. Retrieved from http://ec.europa.eu/growth/tools-databases/cosing/pdf/COSING_Annex%20II_v2.pdf
2. (1961, Jan. 1). The cannabis problem: A note on the problem and the history of international action. Retrieved from https://www.unodc.org/unodc/en/data-and-analysis/bulletin/bulletin_1962-01-01_4_page005.html