Current developments in cosmetics law

Current developments in cosmetics law

More and more unsafe cosmetic products are flooding the European market and regulatory monitoring activities are also increasing. Affected market players should therefore ensure that they are aware of current legal developments and implement them in good time.

On 14.03.2024, the European Commission published its annual report on the Safety Gate, the EU’s rapid alert system for product safety. The rapid alert system enables a rapid exchange of information between the European Member States and the European Commission on dangerous non-food products that pose a risk to consumer health and safety. The report dated 14.03.2024 refers to alerts from 2023 and contains information on the products classified as dangerous, a description of the risks and the measures taken by economic operators or ordered by the authorities.

The annual report shows that in 2023, the Safety Gate recorded the highest number of alerts validated since the system was set up in 2003, with over 3,000 alerts. Apart from this very high number of alerts, the breakdown by product category also differed significantly from the pattern observed in previous years. Last year, the product category “cosmetics” led the way for the first time, ahead of the product categories “toys” and “motor vehicles”. More than 1,000 entries on dangerous cosmetics can be found on the Safety Gate website. Measured against the total number of warnings, the proportion of dangerous cosmetics has more than tripled compared to 2022. According to the report, this trend is due to the fact that the market surveillance authorities increasingly focused on cosmetic products as part of the enforcement of effective restrictions on chemicals under Regulation (EC) No. 1907/2006 (“REACH Regulation”) in order to check for the presence of banned hazardous chemical ingredients.

Against this background, it is not surprising that the legislator has also become increasingly active in the area of cosmetics legislation in recent weeks and months. With the last amendment to Regulation (EC) No. 1223/2009 (hereinafter referred to as the “Cosmetics Regulation”) through the Commission’s Regulation (EU) 2024/858 of 14.03.2024, it banned and restricted a number of nanomaterials in cosmetic products (see I.). In addition, the Borderline Manual, which provides guidance to standard users and competent authorities on the classification of products, has been updated and expanded to include two new entries (see II.). This article presents the current developments in detail.

I. Regulation (EU) 2024/858 – Introduction of new restrictions and bans on nanomaterials

Regulation (EU) 2024/858 (hereinafter referred to as the “amending Regulation”) contains numerous bans and restrictions on the use of nanomaterials in cosmetic products. According to Art. 2 para. 1 lit. k) Cosmetics Regulation, a “nanomaterial” is an insoluble or biologically stable and intentionally manufactured material with one or more external dimensions or an internal structure in the order of 1 to 100 nanometres.

According to Art. 16 para. 1 of the Cosmetics Regulation, a high level of health protection must be ensured for any cosmetic product containing nanomaterials. Taking into account the opinion of the Scientific Committee on Consumer Safety (SCCS) and if there is a potential risk to human health, even if insufficient data is available, Art. 16 para. 6 of the Cosmetics Regulation authorises the European Commission to restrict or completely prohibit the use of nanomaterials in Annexes II and III of the Cosmetics Regulation.

1. New bans on nanomaterials

The European Commission made use of this legislative authorisation with the amending Regulation of 14.03.2024 and, taking into account the scientific opinions of the SCCS, banned the following nanomaterials in the periods between January 2021 and March 2023 by including them in Annex II of the Cosmetics Regulation:

  • Styrene-acrylate copolymer (nano), sodium styrene-acrylate copolymer (CAS No. 9010-92-8);
  • Colloidal silver (nano) (CAS No. 7440-22-4);
  • Copper (nano), colloidal copper (nano) (CAS No. 774-50-8);
  • Gold (nano), colloidal gold (nano) (CAS No. 7440-57-5);
  • Gold thiothylamine hyaluronic acid (nano) (CAS No. 1360157-34-1);
  • Acetylheptapeptide-9-colloidal gold (nano) (CAS No. not specified);
  • Paltin (nano), colloidal platinum (nano) (CAS No. 7440-06-4);
  • Acetyltetrapeptide-17-colloidal platinum (nano) (CAS No. not specified).

What all the above-mentioned nanomaterials have in common is that they can pose a health risk to consumers when the physico-chemical and toxicological aspects as well as the exposure aspects are taken into account together when used in cosmetic products (see recitals (2) to (5) of the amending Regulation).

2. New restrictions for nanomaterials

Furthermore, the European Commission provides for a restriction of hydroxyapatite (nano) (CAS no. 1306-06-5/12167-74-7) in the amending regulation. According to the scientific opinion of the SCCS, hydroxyapatite (nano) should be safe when used in concentrations of up to 10% in toothpastes and up to 0.465% in mouthwashes. However, there would be no data available to assess the safety of consumers from exposure through inhalation, which is why the SCCS emphasised in its opinion that its conclusions do not apply to sprayable products that could lead to exposure of the consumer’s lungs to nanoparticles through inhalation (see recital (6) of the amending Regulation). Accordingly, the use of hydroxyapatite (nano) in cosmetic products poses a potential risk to human health.

Against this background, the Commission has restricted the use of this nanomaterial by including it in Annex III of the Cosmetics Regulation if the concentration of this substance exceeds the specified values in toothpastes and mouthwashes or if it is used in sprayable products that could lead to exposure of the consumer’s lungs to nanoparticles through inhalation.

3. Transitional periods

Finally, the amending Regulation provides for transitional periods so that affected economic operators have sufficient time to comply with the new restrictions and bans. The transitional periods can be found in footnote “(*)” to the Annex to the amending Regulation and stipulate that cosmetic products containing the nanomaterials in question that do not comply with the restrictions and/or bans may no longer be placed on the market in the Union from 01.02.2025 and may no longer be made available on the Union market from 01.11.2025.

II. Update of the Borderline Manual

The European Commission published an updated version of the Borderline Manual on its website on 20.02.2024. This is a manual that is compiled by a working group specialising in cosmetic products and is intended to provide guidance for both provision addressees and competent authorities on product-related borderline issues. Although these are explicitly non-binding guidelines, they can be used by the courts for interpretation in the event of a dispute and thus indirectly gain de facto validity.

The guidance refers specifically to the question of whether a product group falls within the scope of the Cosmetics Regulation or not. The product in question must be a “cosmetic product” in order to fall within the scope of the Cosmetics Regulation (Art. 1 Cosmetics Regulation). According to the legal definition of Art. 2 para. 1 lit. a) of the Cosmetics Regulation, “cosmetic products” are substances or mixtures intended to come into external contact with parts of the human body (skin, hair system, nails, lips and external intimate regions) or with the teeth and vulva of the oral cavity for the sole or predominant purpose of cleansing, perfuming, altering the appearance, protecting, maintaining in good condition or affecting body odour.

The updated version now contains the following two new entries:

  • Section 358 contains a classification guide for glues/adhesives for attaching objects such as artificial nails, false eyelashes and jewellery to teeth, etc. Based on the legal definition of a cosmetic product, the working group clarifies that glues/adhesives that only have the function of attaching an object to an external part of the body, such as the eyelid or nail plate, cannot be considered a cosmetic product as they do not have a cosmetic function. The main function is rather to fix the product to the body.
  • Section 359 addresses the classification of magnetic eyeliners. These are products that are applied above the lash line like a normal eyeliner, but at the same time allow false eyelashes to be attached to the eyelid. As long as it is a coloured magnetic eye pencil that makes it possible to change the appearance, in this case of the eye area, within the meaning of Art. 2 para. 1 lit. a) of the Cosmetics Regulation, it can be classified as a cosmetic product.

III. Outlook

Due to the increase in substance-related findings, not least against the background of the planned strengthening of the European “one substance, one assessment” approach, substance restrictions and bans are also likely to increase within the framework of the Cosmetics Regulation. Although specific changes are partly predetermined by amendments to the CLP Regulation, they may also result from other contexts. It is therefore becoming increasingly important, particularly for responsible persons under the Cosmetics Regulation, to maintain or establish comprehensive and forward-looking substance-related monitoring.

Do you have any questions or would you like to discuss the news with the author? Please contact: Dr. Zeynep Schreitmüller or Michael Öttinger

25. March 2024 Dr. Zeynep Schreitmüller

New prohibited and restricted substances in cosmetics law

Although the comprehensive revision of the EU Cosmetics Regulation announced last year now seems to have been postponed until 2025, developments, particularly on prohibited and restricted ingredients in cosmetic products, are not standing still.

Currently, the focus is on the numerous substance restrictions for microplastics introduced by Commission Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards synthetic polymer microparticles, which has received much media attention. Although the amendments relate to Regulation (EC) No. 1907/2006 (REACH), they will also apply to cosmetic products – in some cases as early as 17.10.2023 (we will publish a separate blog post on this very soon). This is due to the fact that substance restrictions for cosmetic products, which are based on Regulation (EC) 1223/2009 (CPR), are exclusively aimed at protecting human health. Therefore, substances in cosmetic products that at the same time lead to environmental hazards can and must also be restricted. Such restrictions are therefore carried out via the instruments of the REACH Regulation. Thus, both legal regimes must always be kept in view with regard to applicable substance restrictions.

In addition to the above-mentioned substance restrictions under the REACH Regulation, however, those affected should also keep an eye on further developments in cosmetics law. This article therefore presents the latest amendments to the Cosmetic Products Regulation by Regulation (EU) 2023/1490 with regard to CMR substances (see I.) and by Regulation (EU) 2023/1545 with regard to allergenic fragrances (see III.).

I. Regulation (EU) 2023/1490 – Introduction of new CMR substances

Regulation (EU) 2023/1490 serves to maintain legal certainty by adopting classification decisions under the CLP Regulation in cosmetics law.

1. Classification of the Regulation within the European regulatory architecture for hazardous substances

Regulation (EC) No. 1272/2008 (CLP) establishes uniform requirements for the classification, labeling and packaging of chemical substances and mixtures according to the United Nations Globally Harmonized System (GHS).  According to its recital (1), the CLP Regulation aims to ensure a high level of protection for human health and the environment and to ensure the free movement of chemical substances, mixtures and certain specific articles, while enhancing competitiveness and innovation.

To this end, the CLP Regulation provides in Part 3 of its Annex VI for a harmonized classification of substances as carcinogenic, mutagenic and/or toxic for reproduction (CMR) based on a scientific evaluation by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA). Substances are classified as CMR category 1A (known CMR), category 1B (presumded CMR) or category 2 (suspected CMR) according to the level of evidence of their CMR properties.

It is true that cosmetic products within the meaning of the Cosmetic Regulation are expressly excluded from the scope of application of the CLP Regulation pursuant to Art. 1 para. 5 lit. c) CLP . However, Art. 15 paras. 1 and 2 CPR refer to the CLP Regulation. According to this provision, the use in cosmetic products of substances classified as CMR substances of category 2 and categories 1A or 1B according to Part 3 of Annex VI of the CLP Regulation is generally prohibited.

Within the framework of the CLP Regulation, the European Commission regularly classifies new CMR substances, which are transferred to Annex II CPR by means of regulations, in order to establish regulatory consistency with regard to the listing of CMR substances in the sense of greater legal certainty.

2. Basis and content of the Regulation (EU) 2023/1490

Regulation (EU) 2023/1490, also known as the “CMR Omnibus Regulation”, amends the Cosmetic Product Regulation following classification decisions under the CLP Regulation by including new CMR substances whose use will be prohibited in cosmetic products. The amendments to the Cosmetic Products Regulation introduced by Regulation (EU) 2023/1490 will apply from 01.12.2023.

This amendment to the Cosmetic Regulation is due to Delegated Regulation (EU) 2022/692 of 16.02.2022 amending the CLP Regulation for the purpose of adaptation to technical and scientific progress, which was published in the Official Journal of the EU on 03.05.2023. The Delegated Regulation adds a total of 39 new harmonized CMR substances to the list contained in Annex VI CLP, changes the classification of 17 CMR substances already included in Annex VI and deletes one CMR substance included in the list.

According to recital (7) of Regulation (EU) 2023/1490, none of these newly classified CMR substances was previously included in the list of substances banned in cosmetic products according to Annex II of the Cosmetic Regulation. Only the substance 2-ethylhexanoic acid (CAS No. 149-57-5) is listed in Annex II, but the salts of this substance, which have now also been classified as a CMR substance of category 1B by Delegated Regulation (EU) 2022/692, are not included in this entry. Therefore, in order to implement the prohibition on CMR substances uniformly in the internal market, to provide legal certainty and to ensure a high level of protection for human health, these amendments should be transferred to Annex II of the Cosmetic Regulation by Regulation (EU) 2023/1490. Regulation (EU) 2023/1490 consequently amends the Cosmetic Products Regulation to include a total of 30 of the 39 newly classified CMR substances, and the salts of the substance 2-ethylhexanoic acid (in the already existing entry 1024), in Annex II of the Cosmetic Regulation.

Probably the most relevant new entries in practice concern the ingredients benzophenone (CAS No. 119-61-9) and pentasodium pentetate (CAS No. 140-01-2). Benzophenone in particular is regularly found in cremes, shampoos, perfumes and in soaps. The manufacturers of the cosmetic products concerned will therefore each have to use a modified formulation from 01.12.2023 at the latest.

II. Regulation (EU) 2023/1545 – Extended labeling requirements for allergenic fragrances

Regulation (EU) 2023/1545 amending the Cosmetic Products Regulation with regard to the labeling of allergenic fragrances in cosmetic products was adopted on 26.07.2023 and generally applies since 15.08.2023.

1. Regulatory objective of the Regulation

According to its recital (3), the objective of the Regulation is to protect the entire population from the development of fragrance allergies (primary prevention) and persons who are already sensitized to an allergen from the occurrence of allergy symptoms (secondary prevention).

To achieve the objective, recital (4) of the Regulation provides the following: For primary prevention, the European Commission considers a restriction of allergenic fragrances to be sufficient under certain circumstances. However, sensitized individuals may experience symptoms when exposed to allergens at concentrations below the maximum permitted levels. Therefore, according to the European Commission, it is important in the context of secondary prevention to provide information on the presence of individual allergenic fragrances in cosmetic products so that sensitized individuals can avoid contact with the substance to which they are allergic.

2. Background and content of the Regulation

The Cosmetic Products Regulation already provides for corresponding information requirements in its Art. 19 para. 1 lit. g). According to this, a cosmetic product may only be made available on the market if a list of ingredients appears on its packaging. The provision also clarifies that fragrance and aroma substances and their source materials must also be indicated as ingredients using the terms “perfume” or “aroma”. In addition to the terms “perfume” or “aroma”, the presence of substances that must be listed on the packaging according to the “Other” column in Annex III Cosmetic Regulation must also be indicated. Currently, 24 allergenic fragrances listed in entries 45 and 67 to 92 of Annex III CPR must be indicated in the list of ingredients.

Already in June 2012, the Scientific Committee on Consumer Safety (SCCS) confirmed at the request of the Commission that the allergenic fragrances listed in the aforementioned entries of Annex III of the Cosmetic Regulation are still relevant. In addition, 56 other allergenic fragrances have been identified which have clearly caused allergies in humans and which currently do not have to be individually labeled under the Cosmetic Regulation (see recital [6] of the Regulation).

The European Commission is now taking the opinion of the Scientific Committee on Consumer Safety (SCCS) as an opportunity to expand Annex III of the Cosmetic Regulation to include these 56 allergenic fragrances in accordance with scientific findings. As a result, Regulation (EU) 2023/1545 has now added to Annex III CPR an obligation to label these allergenic fragrances individually if they are present in concentrations greater than 0.001% in products that remain on the skin/hair and greater than 0.01% in products that are to be rinsed/rinsed off.

In the course of updating this list, existing entries on allergenic fragrances have also been conceptually and structurally revised for reasons of coherence and clarity. Thus, according to recital (8) of Regulation (EU) 2023/1545, common names of substances were aligned with the latest version of the glossary based on Art. 33 CPR (Commission Implementing Decision (EU) 2022/677 of 31 March 2022 laying down rules for the application of Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the glossary of common ingredient names for use in the labelling of cosmetic products) and similar substances were grouped together in joint entries.

3. Transitional Periods

The update of the list of allergenic fragrances leads to entries in Annex III CPR being created by a combination of existing and new restrictions. For this reason, Regulation (EU) 2023/1545 provides transition periods for economic operators to have sufficient time to comply with the new restrictions and to implement them in the labeling, in addition to the application of the already existing restrictions.

In this regard, the transition periods are structured as follows, according to footnote “(*)” to the Annex of Regulation (EU) 2023/1545:

  • Cosmetic products containing the substances concerned and for which the restriction(s) is/are not complied with may be placed on the Union market until 31.07.2026 and made available on the Union market until 31.07.2028.
  • This gives economic operators a reasonable period of two years from 31.07.2026 to withdraw from the market cosmetic products that do not comply with the new requirements, but which were placed on the market before the new labeling rules came into force if they are not sold off during this period.

III. Outlook – Consequences for the economic operators

Due to the current amendments to both the Cosmetic Products Regulation itself and the REACH Regulation, all manufacturers and importers in particular, in their role as responsible persons for cosmetic products, will have to check whether their products can continue to be placed on the market without adaptation from the respective dates of application of the new requirements. Otherwise, the reformulation and the possibly necessary adaptation of the labeling should be planned with sufficient lead time according to the respective transition periods. This applies all the more to private label manufacturers, who may need even more time for coordination with their respective contract manufacturers.

Do you have any questions about this news, or would you like to discuss it with the author? Please contact: Dr. Zeynep Schreitmüller and Michael Öttinger

16. October 2023 Dr. Zeynep Schreitmüller