Controversies in cosmetics law - KKT Expert Talk (Part Two)

Climate-neutral ­cosmetics – political strategy of the future

The coming years are crucial for the global climate to take the necessary steps towards net zero emissions by 2050. The ‘Fit for 55’ package adopted by the EU Commission plays a crucial role in transforming the European economy towards clean energy systems. The EU Chemicals Strategy for Sustainability and the Circular Economy Action Plan are important elements that will pose new challenges for cosmetics companies in the future. 

The aim of the EU Chemicals Strategy for Sustainability is to better protect human health in the future by creating a toxic-free environment and by banning the most harmful chemicals in consumer products such as cosmetics, toys, detergents and childcare articles. To achieve this goal, the two cornerstones of chemicals legislation – REACH and CLP – and subordinate legislation are currently being revised. An important innovation in this context is the introduction of the concepts of “one substance - one assessment” or “sustainable by design”, where the transparency of the hazard and risk assessment of chemicals as well as the toxicity of chemicals at all stages of their life are taken into account. Similarly, the extension of the generic risk management approach to risk-based prevention measures, applied in several legislative acts, leads to further restrictions. This is based on specific criteria such as the characteristics of the hazard, the risk to certain (vulnerable) population groups, uncontrollable or widespread exposure. Last but not least, the introduction of new hazard classes in addition to the existing ones foreseen under CLP may lead to further restrictions on (cosmetic) raw materials (endocrine disrupters, BT/vPvB (bioaccumulative and toxic/ very persistent, and very bioaccumulative) substances  and persistent and mobile substances that do not degrade in the environment). 

A first candidate is per- and polyfluorinated alkyl substances (PFAS), also known as “forever chemicals” due to their high persistence. They are used in a wide range of consumer products such as textiles, consumer goods and cosmetics because of their non-stick properties. 32 tonnes/year are released into the environment from cosmetics alone.  Environmental contamination with PFAS has now reached alarming levels in almost all ecosystems worldwide. In particular, the dietary intake of PFASs leads to an excess of up to 25 times the weekly tolerable intake dose in humans, especially in infants and young children. On 13th January 2023, the European Chemicals Agency (ECHA) submitted a dossier for a group restriction on PFASs, which will enter into force from 2026/2027 following a positive consultation process. According to the CosIng database, this would affect 170 PFAS cosmetic ingredients. 

Other key milestones in the EU’s sustainability strategy are the Circular Economy Action Plan and the Zero Pollution Action Plan.  The aim is to return valuable resources to the cycle by making plastic packaging recyclable or reusable by 2030 and to reduce all sources of microplastic pollution. First drafts are already available, such as the draft regulation on synthetic microplastic particles, which foresees a ban on polymers in cosmetics with transition periods of 2-6 years, or the draft regulation on packaging and packaging waste. From 2030, all (cosmetic) packaging must be recyclable and contain a minimum proportion of recycled material. 

As if that were not enough, the revision of the Cosmetics Ordinance is also imminent. The aim is to adapt the Cosmetics Ordinance to the restrictions and limitations described above in the direction of the sustainability strategy and to integrate them into the Cosmetics Ordinance. The Commission is expected to present a proposal to this effect at the end of June 2023.

Even if the implementation is still in its infancy, cosmetics companies will have to face these new challenges of implementing a sustainability strategy in the company. This can be time consuming and costly.  But it is essential if you want to stay ahead of your competitors and customers. After all, it is about our health and our environment.

Between CLP and cosmetics regulation: Do-It-Yourself in the border area

If products are supplied to consumers for the Do-It-Yourself sector, the question arises as to whether these are covered by the general chemicals legislation (CLP) or are subject to the regulations of the EU Cosmetics Regulation. The definition of cosmetic products according to Art. 2 (1a) of Regulation (EC) No. 1223/2009, refers to all “substances and mixtures” which are provided with a predominant cosmetic purpose, whereby such a purpose can also be expressed implicitly and taking into account the perception of the market. The definition does not contain a characteristic “finished product”.

In general, consumers use such substances and mixtures for their personal use or outside of a commercial activity, so that they, like persons who use cosmetic products professionally (cosmeticians, hairdressers), belong to the “end consumers” as defined by the EU Cosmetics Regulation and are not “manufacturers” as defined by that regulation. As a consequence, all substances and mixtures that are commercially supplied to an end user with a predominantly cosmetic purpose fall under the requirements of the EU Cosmetics Regulation. This applies to so-called “cosmetic kits” as well as to “refill products” and other separately supplied substances and mixtures. The distributors of these products must therefore also comply with the requirements for the responsible person, in particular ensuring proper labeling, notification, product information file and toxicological safety assessment. The latter is a particular challenge, as it needs to cover the evaluation of all intended uses, making a clear and comprehensive description of use and potential warnings essential.

Due to the regulatory situation, an entry in the “Borderline Manual” of the EU Working Group on Cosmetic Products can be misunderstood if it states that substances and mixtures that are not provided with specific instructions on how to make a cosmetic product out of them are not cosmetic products. It is not a question of specific instructions, but of whether the product has a predominantly cosmetic purpose. If this is the case, the lack of a required instruction does not lead to the inapplicability of the cosmetics law, but rather to the lack of marketability as a cosmetic product due to the application of the cosmetics law. This also applies to substances and mixtures that do not have a cosmetic effect themselves, but are intended to be used as technological auxiliaries in the “production” of do-it-yourself cosmetics (e.g. as preservatives). This also results from the definition of cosmetic products, which in other language versions than the German one expresses more clearly that all substances and mixtures are to be covered which are placed on the market “with a view to” a predominant cosmetic application.

Decisions and opinions on the definition of cosmetics

In a decision dated 13th October 2022, the European Court of Justice stated in the case of an ‘Eyelash Activating Serum’ that a classification as a functional medical product requires at least the enabling of treating a recognized disease. According to this, products for improving the appearance without such a health-promoting effect basically meet the cosmetics definition, so that the question of product safety can be examined on the basis of the EU Cosmetics Regulation. A broad interpretation of the cosmetics definition was also advocated by Karlsruhe Higher Regional Court in its judgement from 28th January 2016 regarding a “wound care cream” with the indication “for sensitive and irritated skin areas”. In the court’s view, these claims do not necessarily imply a reference to pharmaceuticals. There are also cosmetic products on the market for the treatment of sore skin that focus on body care and skin protection, with healing effect just as a desirable side effect. Regarding the The Working Group of Food Chemistry Experts`(ALS) Opinion No. 2022/12 on bath tablets, it should be noted that a predominantly cosmetic purpose results from the product presentation, but contrary to the misleading presentation, not from the ingredients. As clarified in a decision of the Münster Administrative Court of August 21, 2019, a purpose for playing and thus the classification of a product as a toy does not yet result from a ‘child-appealing’ product design.
The Working Group of Food Chemistry Experts`(ALS) Opinion No. 2022/13 on products that are simultaneously offered as detergents and cleaning agents and as cosmetic products does not appear to be entirely accurate. Thus, if the cosmetic and non-cosmetic purposes of such a product are equivalent from the consumer’s point of view, the cosmetic definition is not fulfilled. In this - probably rather theoretical - case, the product is not subject to cosmetics law, but to the CLP Regulation. If a product (e.g. because it is intended for cleaning textiles) at least also fulfills the definition of a detergent, the Detergents Regulation always applies in addition. This also applies if the product is mainly intended for cosmetic purposes, as there is no exemption for 
cosmetic products in this respect.

Effect or purpose – what about the positive lists of EU Cosmetics Regulations? 

Cosmetics manufacturers enjoy a high degree of freedom in the selection of their raw materials. However, they must select preservatives and UV filters from a list. These positive lists contain substances that have been thoroughly toxicologically tested and reviewed by an independent panel.

Preservatives are germicidal and often allergenic. As a result, they have a negative image among certain consumers. Clever manufacturers are replacing such substances with so-called multifunctional substances. Although these substances are biocidal, other functions are attributed to them. Examples are anisic acid and levulinic acid. While there is proof for the biocidal effect, there is a lack of evidence for the claimed masking or perfuming properties. Examples are products containing anisic acid or levulinic acid, which were not declared in one third respectively half of the findings. Dr Urs Hauri and his working group consider this as deception and it complicates the work of dermatologists in case of complaints.

UV filters protect against UV radiation. To achieve protection, up to ten grams of these substances are needed. The filters undergo electronic excitation when absorbing the radiation and can thus decay or undergo reactions, with unknown consequences for health. Photostabilizers are therefore needed. Although sufficient approved UV filters are available for this purpose, “multifunctional” substances are marketed, e.g. butyloctyl salicylate and tridecyl salicylate, two close relatives of the approved filters ethylhexyl salicylate and homosalate. Although the UV absorption is practically identical, they are claimed to be solvents, photoboosters and stabilizers or emollients that are said to have no effect on the SPF factor, although this is easily chemically disprovable.

Dr Urs Hauri and his working group consider the misuse of non-approved UV filters and preservatives to be questionable and deceptive. The purpose of the positive lists is undermined: Intensively tested and reviewed substances are replaced by less extensively tested and not independently reviewed substances. This is despite the fact that the substitutes have the same biological and chemical functions and therefore the same need for toxicological testing. 

Especially for preservatives, more good and safe substances are missing on the positive list. Raw material manufacturers should therefore carry out the necessary toxicological tests for inclusion in the positive lists and apply for inclusion.

Further Parts The lectures were held on the KKT organized by the Chemical and Veterinary Investigation Office Karlsruhe (CVUA Karlsruhe). More information: www.ua-bw.de  Part Three: New raw materials Part Four: Trends in raw materials and active ingredients