What's changing in 2026: Life Science

Tag: Cosmetics

What’s changing in 2026: Life Science

In 2026, the developments initiated in 2025 continue. The focus remains on the draft proposal published by the European Commission on 16 December 2025 concerning the reform of the MDR and IVDR. Beyond this, digitalization continues to represent a central theme in the life sciences sector, including at the national level. In this context, particular emphasis is placed on reducing bureaucratic burdens as well as on data protection and data transparency.

This article is the penultimate part of the blog series “What’s Changing in 2026,” in which the experts of the Produktkanzlei summarize key topics from their respective practice areas. Here, we examine the developments relating to the MDR, including the Commission’s draft amending regulation for the MDR/IVDR (see under A.). At the national level, we discuss the simplification of the conduct and approval of clinical investigations and performance studies (see under B.). Further topics include the Data Act (see under C), the AI Act in the medical device sector (see under D.), the rollout of the electronic patient record (see under E.), and updates regarding digital health applications (see under F.). Finally, we provide an overview of the changes in cosmetics law (see under G.).

A. MDR and IVDR

In 2026, the MDR and IVDR continue to be at the forefront of both regulatory and practical developments. The European Commission’s latest reform proposal, the expiration of transitional periods, and emerging advances in digitalization are collectively shaping the evolving regulatory landscape.

I. Draft Reform

On 16 December 2025, the Commission published a draft amending regulation for the MDR and IVDR. This proposal contains numerous, in part fundamental, adjustments. The overarching aim of the reform is to make the MDR/IVDR more efficient, transparent, and innovation‑friendly – without reducing the high standards for safety, quality, and patient protection. The primary focus is on simplifying and reducing the regulatory burden, which has proven substantial under the current framework.

The intended improvements include clearer structuring of conformity assessment procedures, increased predictability, and enhanced cost‑efficiency. For example, fee reductions may be introduced for SMEs and orphan devices, and the Commission would be empowered to define the structure and amount of such fees. A new dispute‑resolution mechanism between manufacturers and notified bodies is also planned: the authority responsible for the notified body would act as an “ombudsman” in case of disagreements.

At the same time, digitalization should be used to speed up processes and simplify communication between manufacturers, authorities and notified bodies.

To promote innovation, the draft reform provides for the introduction of so-called ‘regulatory sandboxes’. These enable manufacturers to develop, test, validate and, if necessary, use innovative products under real conditions for a certain period of time under official supervision without having to meet all regulatory requirements.

A particular focus lies on enhanced harmonization within the EU to avoid regulatory overlap and ensure a coherent framework. For instance, the MDR/IVDR and the AI Act are to be better aligned.

The draft additionally introduces new information‑sharing and cooperation obligations for Member States to mitigate structural issues related to shortages. The EMA will monitor shortages and support national authorities and the Commission. Moreover, aligned with the newly effective Article 10a MDR/IVDR (early 2025), a positive list of critical medical devices shall be established, and an IT portal for reporting supply interruptions will be created.

The public consultation runs until 16 March 2026, so comments on the draft can be submitted until then. The proposal will now be presented to the European Parliament and Council for adoption. The trilogue negotiations are planned for spring 2026. It remains to be seen whether the reform will be implemented within 2026.

II. Transition Periods

On 26 May 2026, the transitional period for custom‑made implantable Class III devices under the MDR ends.

2026 also marks the end of the IVDR transition period for Class C products, for which the involvement of a notified body was already required under the IVDD. A formal application for these products must be submitted to the notified body by 26 May 2026. As a result, a written contract with a notified body must be in place no later than four months after the application is submitted, i.e. by 26 September 2026, for these products to continue to be placed on the market.

III. Electronic Instructions for Use – eIFU

In 2025, the scope for electronic instructions for use was significantly expanded, but only for professional users, not laypersons. On 25 June 2025, the Commission adopted Implementing Regulation (EU) 2025/1234 amending Implementing Regulation (EU) 2021/2226 regarding the types of medical devices for which instructions may be provided electronically. The amending regulation provides for a significant expansion of the scope of application of electronic instructions for use (eIFU) in place of paper instructions for use, but it is still not possible to introduce eIFU across the board for products intended for use by laypersons. Implementation remains optional for manufacturers. The implementing regulation entered into force on 26 July 2025.

IV. EUDAMED

On 27 November 2025, the Commission published Decision (EU) 2025/2371 on the announcement of the functionality and fulfilment of the functional specifications of certain electronic systems contained in the European Database on Medical Devices and on the declaration of functionality of the first four modules in the Official Journal of the European Union. In accordance with the transitional provisions of Regulation (EU) 2024/1860, this marks the start of the six-month transition period.

Accordingly, the first four EUDAMED modules will become mandatory from 28 May 2026:

  • Actor registration (Art. 30 MDR / Art. 27 IVDR) — already nationally mandatory in Germany since 26 May 2021 
  • UDI database and device registration (Art. 28–29 MDR / Art. 25–26 IVDR) 
  • Notified bodies and certificates (Art. 57 MDR / Art. 52 IVDR) 
  • Market surveillance (Art. 100 MDR / Art. 95 IVDR)

For legacy products placed on the market before 28 June 2025, an additional transition period applies: Manufacturers and distributors of systems and treatment units must have registered such existing products in the UDI/Product Module by 27 November 2026 at the latest.

B. Simplification of Clinical Investigations and Performance Studies – Standard Contractual Clauses

On 18 September 2025, the German Federal Government published the Regulation on on standard contractual clauses for the conduct of clinical trials (Standard Contractual Clauses Regulation – StandVKlV) for medicinal products. This regulation applies to contracts for clinical trials of medicinal products concluded on or after 17 December 2025.

Sec. 31c of the Medical Devices Implementation Act (MPDG) also provides for the possibility of establishing standard contractual clauses for clinical trials and performance studies by means of a statutory order for medical devices and IVDs.

The enactment of a corresponding regulation is expected in the near future in 2026. The aim is to standardise and facilitate contract negotiations for manufacturers, sponsors and trial centres.

C. Data Act

The Data Act (Regulation (EU) 2023/2854) entered into force in January 2024, establishing a legal framework for fair access to and use of data. Its provisions have been binding since 12 September 2025.

In Germany, the federal government adopted a draft bill from the Federal Ministry of Digital and Public Service Modernisation on 29 October 2025. The aim is to adapt national legislation so that the provisions of the Data Act can be enforced without hindrance and violations can be effectively sanctioned. In this respect, the designation of the Bundesnetzagentur as the competent national authority (Sec. 2 of the draft) is also of central importance.

D. Artificial Intelligence Act – AI Act

The AI Regulation will apply from 2 August 2026. The central classification rules and requirements for high-risk AI systems will only apply from 2 August 2027, in accordance with Art. 6(1) AI Act.

However, the Commission has now published a proposal for a digital omnibus regulation on AI in order to simplify and relax the rules. According to this omnibus proposal, the rigid application deadlines previously envisaged are to be replaced by a dynamic mechanism. For systems covered by Annex I AI Act, companies would be given 12 months longer to adapt to the changed legal situation. This also applies to the MDR and IVDR. However, the relevant obligations may apply earlier if the Commission confirms that sufficient measures to support compliance (such as harmonised standards and common specifications) are in place. The proposal is currently still in the legislative process – whether and in what form the changes will actually be implemented is currently open. Manufacturers should therefore not rely on this proposal, but should already start addressing the complex additional requirements of the AI Act.

Irrespective of this, structural changes for medical devices in conjunction with the AI Act are to be expected in view of the planned reform of the MDR and IVDR. The Commission’s draft MDR reform provides for the MDR and IVDR, which are currently listed in Annex I of the AI Act, to be moved to Section B. As a result, the full high-risk regime of the AI Act would no longer apply directly to medical devices and IVDs, but the application of the AI Act would be limited to the horizontal provisions referred to in Art. 2(2) AI Act. At the same time, a revision of Art. 5(8) MDR is intended to clarify that the European Commission must take into account the requirements for high-risk AI systems in accordance with Chapter III, Section 2 AI Act when drafting implementing and delegated acts. As a result, the requirements of the AI Act would not be completely eliminated, but would be systematically integrated into the MDR. In this way, the Commission aims to avoid unclear overlaps between the MDR/IVDR and the AI Act.

E. Electronic Patient Record (ePA)

Since 1 October 2025, the use of the ePA has been mandatory for all doctors in Germany.

From 1 January 2026, software systems that have received confirmation of conformity for the use of the ePA and are therefore ‘ePA-ready’ must be in use. Doctors who use systems that are not ePA-compatible or who cannot provide proof of using a compliant system risk having their fees reduced and their IT flat rate cut. To avoid hardship cases, the National Association of Statutory Health Insurance Physicians can issue corresponding interpretation guidelines.

In addition, the ePA will be supplemented by a medication plan in the course of 2026. The electronic medication plan supplements the medication list with information such as dosage and instructions for use.

F. Digital Health Applications (DiGA)

Further developments are ongoing with regard to DiGA. On 28 October 2025, the Federal Ministry of Health published a draft bill to amend the Digital Health Applications Regulation (DiGAV).

This draft amendment primarily takes into account applications that constitute an AI system in accordance with the AI Regulation. Furthermore, new regulations for the gradual implementation of the AbEM were defined on the basis of the legal requirements of SGB V.

G. Changes in Cosmetics Law

The Omnibus VI Regulation (2025/0531/COD) aims to introduce not only simplifications in chemicals legislation, but also amendments to Regulation (EC) No 1223/2009 (hereinafter “Cosmetic Regulation”). The adoption of the draft is expected later this year.

The amendments concern, among other things, a new procedure for the inclusion of additional colourants, preservatives and UV-filters in Annexes IV, V and VI of the Cosmetic Regulation. Where it can be scientifically demonstrated that the use of a substance in a cosmetic product is safe, its inclusion should be made possible through a procedure set out in a new Article 14a Cosmetic Regulation. The timeline for this procedure is intended to be accelerated through legally defined deadlines.

Art. 15 Cosmetic Regulation generally prohibits the use of substances classified as CMR under Regulation (EC) No 1272/2008 in cosmetic products. The changes introduced by Omnibus VI involve a substantial expansion of the possibilities for the exceptional use of such CMR substances.

Furthermore, the notification requirement for products containing nanomaterials within the meaning of Art. 16 (3) – (7) Cosmetic Regulation is to be removed. In addition, the glossary of ingredient names is to be abolished, with future references made directly to the International Nomenclature of Cosmetic Ingredients (INCI) in order to avoid delays in incorporating new entries into the glossary.

On 12 January 2026, Regulation (EU) 2026/78 (as part of Omnibus VIII) was adopted, amending the Cosmetic Regulation by adding newly classified CMR substances and placing them on the respective lists of prohibited, restricted or permitted substances.

Do you have any questions about this news or would you like to discuss it with the author? Please contact: Prof. Dr. Boris Handorn and Anna Christ

20. January 2026 Prof. Dr. Boris Handorn & Anna Christ
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Prof. Dr. Boris Handorn
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Amendment to the Cosmetics Regulation: Are nail salons really no longer allowed to use products containing TPO? A legal assessment

In a recent blog post, we highlighted the latest amendments to Regulation (EC) No. 1223/2009 on cosmetic products (hereinafter referred to as the “EU Cosmetics Regulation”)—in particular, the inclusion of numerous CMR substances in Annex II of the EU Cosmetics Regulation, implemented by Regulation (EU) 2025/877.

One particularly relevant point concerns the inclusion of the photoinitiator trimethylbenzoyl diphenylphosphine oxide (TPO, CAS 75980-60-8), which is widely used in the nail industry: Due to its new classification as toxic to reproduction category 1B, TPO is listed in Annex II of the EU Cosmetics Regulation and may no longer be used in cosmetic products from 01.09.2025. For the industry, this means checking formulations, reformulating them if necessary, or withdrawing products from the market in good time.

In practice, however, nail salons and other professional users are faced with the question: What will apply from 01.09.2025, to the use of existing products that contain TPO?

The European Commission published non-binding, interpretatory FAQs on this topic on 07.08.2025. These state that professional users will no longer be allowed to use such products on customers from 01.09.2025:

“(…) a professional user e.g. nail technician, salon) cannot use such a product on clients from 1 September 2025 onwards, because this constitutes ‘making available on the market’ in the course of a commercial activity. This applies regardless of whether the product was purchased before the cut-off date.”, availble under: TPO in Nail Products – Questions & Answers – European Commission (last accessed on 27.08.2025)

We do not consider this interpretation to be valid. This is because nail salons do not place TPO-containing cosmetic products on the market or make them available on the market by applying them to their customers’ nails.

In detail:

According to Art. 15 para. 2 EU Cosmetics Regulation, the use of substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMR) in categories 1A or 1B according to Regulation (EC) No. 1272/2008 on the classification, labeling, and packaging of substances and mixtures is generally prohibited in cosmetic products. Once the respective harmonized classification comes into force, cosmetic products containing such substances may no longer be placed on the market from the relevant date.

According to Art. 2 para. 1 (h) EU Cosmetics Regulation, placing on the market means “the first making available of a cosmetic product on the Community market.” Making available on the market means “any supply of a cosmetic product for distribution, consumption, or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge,” Art. 2 para. 1 (g) EU Cosmetics Regulation. This is the case, for example, when an economic operator—e.g., the manufacturer—places such cosmetic products on the Union market (for the first time) for distribution to a distributor.

A nail salon would therefore have to supply such cosmetic products after 01.09.2025, for distribution, consumption, or use in the course of a commercial activity in order to be affected by the ban. However, the nail salon does not supply the cosmetic product containing TPO, but uses it itself to apply it to the nails of its customers (see for further details on the interpretation of the term “making available on the market” Blue Guide, p. 19). Therefore, there is no supply for use in a commercial activity. Rather, the application in the context of the nail salon’s activities constitutes the use itself.

This understanding is further supported by the fact that the EU Cosmetics Regulation only imposes obligations on economic operators, but not on end users. An end user is

“either a consumer or professional using the cosmetic product,” Art. 2 para. 1 (f) EU Cosmetics Regulation.

In nail salons, cosmetic products are used professionally, so that, according to the existing legal definition, the nail salon is explicitly and unequivocally considered an end user and is therefore not subject to any prohibitions or obligations under the EU Cosmetics Regulation. The wording clearly states that professional users, such as nail salons, use cosmetic products exclusively for the purpose of application and that this does not constitute a supply for use, as is erroneously assumed by the EU Commission. Logically, a mere user cannot at the same time be a distributor with regard to one and the same process, in this case the use of a TPO-containing product to accelerate the curing of gels and varnishes.

Even if there may be good scientific and toxicological reasons for discontinuing the sale and use of products containing TPO as soon as possible, there is no legally tenable argument for a ban on their use from 01.09.2025. The wording and structure of the EU Cosmetics Regulation clearly and unequivocally state that cosmetic products containing TPO may continue to be used in nail salons even after 01.09.2025 (the sale of products to customers, on the other hand, should be viewed more critically, even if it is not entirely clear that this is prohibited). Nevertheless, the Member States and competent market surveillance authorities are likely to follow the EU Commission’s FAQs and enforce the alleged ban on use on this basis. However, nail salons affected by this should defend themselves against any orders and fines in this context using the above argument, as such orders and fines would be based on an incorrect understanding of the law and are therefore likely to be unlawful.

Link to our initial blog post: Evaluation of the EU Cosmetics Regulation: Public consultation and new substance bans under Regulation (EU) 2025/877

Do you have any questions or would you like to discuss the news with the author? Please contact Michael Öttinger and Marie Carnap

27. August 2025 Michael Öttinger
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Evaluation of the EU Cosmetics Regulation: Public consultation and new substance bans under Regulation (EU) 2025/877

Cosmetics legislation is subject to constant change. On the one hand, this is because new findings on substances contained in cosmetic products have an impact on their use. On the other hand, the overall regime is now more than 15 years old and is currently under review.

A. Ongoing investigation into the EU Cosmetics Regulation

The European Commission is currently reviewing the appropriateness of Regulation (EC) No. 1223/2009 on cosmetic products (EU Cosmetics Regulation) as part of a comprehensive evaluation. The aim of this initiative is to analyze whether the EU Cosmetics Regulation continues to be effective, efficient and coherent in terms of better regulation, in particular with regard to consumer health protection, the handling of hazardous substances and compatibility with other EU regulations. The current public consultation is open until 28.07.2025 and is aimed at consumers, manufacturers and other economic operators as well as supervisory authorities and non-governmental organizations (NGOs). The feedback is to be incorporated into a comprehensive assessment, on the basis of which a decision will be made as to whether the regulation needs to be revised. The focus will also be on the question of whether the EU Cosmetics Regulation is serving its purpose with regard to the green and digital economy.

On 08.07.2025, the EU Commission also presented a further proposal to simplify chemicals legislation. This also includes changes to the EU Cosmetics Regulation, such as the introduction of a legally standardized procedure for the inclusion of colorants, preservatives and UV filters in the corresponding Annexes IV, V and VI of the EU Cosmetics Regulation, the specification of the procedure for exemptions from the general ban on the use of CMR substances in cosmetic products in accordance with Art. 15 EU Cosmetics Regulation and the abolition of the legislative procedure for defining the glossary of ingredients.

B. Current substance-related changes

Against this background, selective amendments to the annexes of the EU Cosmetics Regulation, for example to implement current chemical law assessments, are becoming increasingly important.

With Regulation (EU) 2025/877, the European Commission made a further amendment to the EU Cosmetics Regulation on 12.05.2025. Significant changes result from the annex to this amending regulation, with which a number of substances – due to their classification as carcinogenic, mutagenic or reprotoxic substances (CMR substances) of category 1A, 1B – were included in Annex II (list of prohibited substances in cosmetic products). The new prohibitions will apply from 01.09.2025.

The background to the amendment is the harmonized classification of certain substances as carcinogenic, mutagenic or toxic to reproduction in accordance with Regulation (EC) No. 1272/2008 (CLP Regulation). Specifically, the amendment to the CLP Regulation is based on Delegated Regulation (EU) 2024/197, which reclassified numerous substances as CMR substances in January 2024.

The affected substances include trimethylbenzoyl diphenylphosphine oxide (CAS 75980-60-8), which was previously approved as an ingredient in certain nail shaping products. Due to the new classification as toxic for reproduction category 1B, the substance is now included in Annex II of the EU Cosmetics Regulation and may no longer be used in cosmetic products from 01.09.2025. The amendment also affects a large number of other substances, including various phosphoric acid esters, tin compounds, bisphenol AF and other bioactive substances that were considered as preservatives or UV filters, for example.

For manufacturers of cosmetic products, this means there is an urgent need for action: all formulations must be checked to see whether they contain any of the newly listed substances. If this is the case, the product in question must be adapted before 01.09.2025. In this context, the safety reports and labeling must also be updated accordingly. It should also be noted that any outer packaging and labels must also be adapted if they contain a declaration of a now banned ingredient.

The recently published Regulation (EU) 2025/877 shows once again how closely cosmetics legislation is interlinked with chemicals legislation – in particular the CLP Regulation. Companies are therefore well advised to follow new developments in the classification of substances at an early stage and to systematically anticipate regulatory consequences. With a view to future changes to the harmonized classification of substances, further amendments to the annexes of the EU Cosmetics Regulation can also be expected in the coming years.

Do you have any questions or would you like to discuss the news with the author? Please contact Michael Öttinger and Marie Carnap

10. July 2025 Michael Öttinger
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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
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Dr. Zeynep Schreitmüller
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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
Bild Dr. Zeynep Schreitmüller
Dr. Zeynep Schreitmüller
Lawyer / Associate

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