#TitaniumDioxide #TiO2 #RiskAssessment 

The European Court of Justice confirmed the annulment of the classification of titanium dioxide (TiO₂) in powder form as “suspected of causing cancer by inhalation,” pointing to methodological deficiencies in the basic studies. This substance remains widely used in paints, plastics, cosmetics and medicines, and its potential health effects – especially genotoxicity and risks related to nanoparticles – are still the subject of ongoing research. 

What is TiO₂ and where is it used? 
Titanium dioxide is one of the most commonly used pigments in the world – its production reaches millions of tonnes annually. It is primarily used in: 

• paints, coatings, plastics and paper, 

• cosmetics (e.g. toothpastes, sunscreen products as a UV filter), 

• pharmaceuticals (as colouring agent E 171), 

• and until 2022 also as a food additive (E 171). 

Research and classification – controversies 

• Genotoxicity: In 2021 EFSA concluded that the genotoxic potential of TiO₂ could not be excluded, which led to the ban on the use of E 171 in food throughout the EU. 

• Carcinogenicity: Since 2006 IARC has classified TiO₂ as “possibly carcinogenic to humans” (Group 2B), based on animal studies which showed lung cancer after prolonged inhalation of high doses of respirable particles (< 10 µm). In 2020 the European Commission harmonised the classification of TiO₂ in this category, but the decision was annulled by the General Court. 

The CJEU confirmed that the studies underlying the classification did not sufficiently take into account biological mechanisms such as lung overload nor the physicochemical properties of the particles. Consequently, it was recognised that it cannot be concluded that TiO₂ possesses an intrinsic carcinogenic property. 

Risk assessment vs hazard assessment 
The rulings underline the difference between hazard assessment (typical for CLP, which identifies potential harmful properties of a substance) and risk assessment (which considers actual exposure, its dose, duration and route of uptake). TiO₂ may constitute a hazard only under very specific conditions – e.g. during prolonged and intensive inhalation of dust containing respirable particles. 

Particle size and exposure routes 

• Particles > 10 µm: retained in the upper respiratory tract, considered less problematic, 

• Particles ≤ 10 µm: can reach the lungs, cause inflammation and fibrosis, 

• Nanoparticles (< 100 nm): penetrate into pulmonary alveoli, where they may induce inflammation and mechanical damage. 

Potential risks vary depending on the exposure route: 

• Inhalation – the greatest risk, 

• Oral ingestion – EFSA points to particle biopersistence and possible genotoxic effect, 

• Dermal contact – no evidence of absorption or systemic effects. 

Examples of uses in products: 

• Sunscreens: nano-TiO₂ at concentrations up to 25% has been assessed as safe – it does not penetrate into the bloodstream, and is regulated under the Cosmetics Regulation. 

• Toothpastes: safety assessment by SCCS is still ongoing. 

• Medicines: E 171 remains permitted as a colouring agent in medicinal products under Directive 2009/35/EC. 

Significance for industry and consumers 
The CJEU decision means that the current classification of TiO₂ in powder form as a substance “suspected of causing cancer” is no longer applicable in EU law. This is particularly important for industries that widely use TiO₂ – paints, coatings, cosmetics and pharmaceuticals. At the same time, research on the genotoxicity and safety of TiO₂, in particular in nano forms, will continue. 
 
Source: ECHA – Guide on classifying and labelling titanium dioxide 

#REACH #SME  

ECHA actively verifies the size of companies that have applied for SME status when registering a substance under REACH. Check that the size of the company has been correctly declared and, if not, inform ECHA to avoid an administrative fee of up to €19,900. 

In the procedure for registering a substance under REACH, the size of the company must be indicated. The size of the company determines the amount of the fee to be submitted to ECHA.  

If you used the micro, small or medium-sized enterprise (SME) discount when registering your substance, make sure that the status is declared correctly. In case of non-compliance, you must inform ECHA and correct the company size in REACH-IT, then only the difference in the fees will be added. If ECHA detects a discrepancy, you may be charged an administrative fee of up to €19,900.  

Guidance on determining the size of a company is available on the ECHA website.  

What does that mean? 

Log in to REACH-IT, check the correctness of the data and the size of the company and, if required, make a correction and notify ECHA of the change in data. 

Source: https://echa.europa.eu/pl/-/sme-registrants-check-your-company-size-and-documents#msdynmkt_trackingcontext=afb352ad-b4cb-4b7e-85f9-18928deb0300  

Ekotox website: https://ekotox.eu/reach-registration/  

#REACH #SVHC  

ECHA proposed to add 3 new substances as SVHCs. 

The European Chemicals Agency has proposed to identify 3 new chemicals as substances of very high concern due to their negative effects on human health or the environment. (SVHC) 

These are: 

• n-hexane, used in polymer formulations and processing, as well as in coatings and cleaning agents 

• 4,4′-methyleneodiphenol (BPF, bisphenol F) 

• 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and its salts, used as process regulators in polymeric materials and in rubber production and processing 

Consultations are open until 16 October 2025. 

What does that mean? 

• Obligation to inform the recipient and consumer about the presence of SVHCs in articles. 

• Obligation to report the article to the SCIP database if the amount of SVHCs in the article exceeds 0.1%. 

• If a substance is identified as an SVHC, it can be added to the Candidate List for final inclusion in the list of substances subject to authorisation. 

Source: https://echa.europa.eu/pl/substances-of-very-high-concern-identification?utm_campaign=5cfdec6599bdab0001a52896&utm_content=68b973f9af753d0001d124f7&utm_medium=smarpshare&utm_source=linkedin  

Exotox website: https://ekotox.eu/substances-of-very-high-concern-svhc/  

#CMRD #Exposure limits #CMR 

A proposal for the CMRD Directive has appeared on the Commission’s website, which proposes to set new limits for exposure to certain chemical compounds. Once approved, member states will have 2 years to implement the rules into national law. 

The European Commission has proposed the sixth revision of the CMRD Directive, on carcinogens, mutagens and reprotoxic substances. The amendments include updating Annexes I, III and IIIa to the Directive by adding new substances and adapting existing limit values to improve the safety of workers in the workplace. 

This new initiative updates Annexes I, III and IIIa to the Directive by adding new substances and adapting existing limit values. 

The proposed changes include setting new exposure limits for: 

It is worth noting that PAHs are substances subject to REACH restrictions and 1,4-dioxane is one of the substances of very high concern, included in the list of substances for possible inclusion in Annex XIV. 

Another change is the inclusion of welding fumes in the CMRD Directive and the obligation to use protective measures by workers exposed to smoke. 

In addition, the Commission has proposed markings and warnings for workers about possible exposure, as well as an indication of when additional personal protective equipment is necessary. 

What does that mean? 

• Verification of workplaces where workers are exposed to hazardous substances 

• Additional obligations for employers to monitor, assess and mitigate risks 

• Update of data in section 8 of the safety data sheet 

Source: https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1864  

At the beginning of 2025, the Ukrainian REACH regulation, modeled on the European regulation on the registration of chemical substances, came into force. The regulation imposes an obligation to register chemical substances placed on the Ukrainian market. By 26 of January 2026, pre-registration and registration of substances classified as CMR and Aquatic hazardous in category 1 must be completed.

Due to the increased interest in REACH registration in Ukraine, we present a summary of the most important information below:

New obligation:

Registration of a substance on its own or in a mixture, manufactured or imported in quantities of more than 1 tonne per year.

Who is covered:

Manufacturer, importer or authorized representative established in the territory of Ukraine.

Does it apply to European entities:

Not directly, but appointing an authorized representative who will take over the responsibility for completing the formalities makes it easier to do business with entities in Ukraine, who are thus exempt from the obligation to register substances. Otherwise, it is the importer who must take over all administrative and information obligations.

Terms:

• 26 January 2025 – entry into force of the Ukrainian REACH regulation
• by 26 January 2026 – pre-registration of substances
• by 26 January 2026 – registration of CMR substances ≥1 t/year; substances hazardous to the environment (category 1) with a volume of ≥100 tonnes/year
• by 1 October 2026 – registration of substances in tonnage ≥1,000 t/year
• by 1 June 2028 – registration of substances in tonnage 100-1000 t/year
• by 1 March 2030 – registration of substances in tonnage 1-100 t/year

Why register your substance by 26 January 2026:

Pre-registration allows products that were present before the entry into force of the legal act to be maintained on the Ukrainian market, as well as to be used until the substance is fully registered.

What to do step by step:

• Appoint your representative in Ukraine
• Collect information about the substance or substance contained in the mixture.
• Complete the pre-registration technical document, and submit it through your designated representative.
• Send the pre-registration form to the Ministry and get a pre-registration number for your substance.
• Look for a consortium and others registering the same chemical to collaborate and submit a common dossier for the substance.
• Submit your application for full registration of your substance in good time.

Current work status for pre-registration:

• The Ministry receives more and more applications for pre-registration of substances.
• The Ministry of Ukraine accepts applications signed with an electronic signature, sent to the appropriate e-mail address.
• Once the application is submitted, a pre-registration number is assigned within a few days.
• Work is underway to implement an automated electronic system for the registration of substances.
• In February 2026, a list of substances with pre-registration will be published.

Ekotox website: https://ekotox.eu/export-services-in-ukraine/

The European Commission has proposed a package of simplifications for the revision of the CLP Regulation published in 2024. Below we present a summary and dates of entry into force of potential simplifications of the regulations.

In November 2024, Regulation (EU) 2024/2865 of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, the so-called revision of the CLP Regulation, was published. The new regulation assumes for example: new classification rules, new labelling requirements, new regulations on advertising and distance sales or requirements for refilling stations. Most of the changes come into force from 1 July 2026.

After the content of revised CLP was published, the industry pointed out many difficulties to implement some of the new rules. The main problem was the use of the right format with a limited size of the label or packaging, which was also associated with more expensive labels and generating more waste. It also pointed out the difficulties in including all information about the danger in marketing materials and the possible overwhelming of the consumer with the amount of information.

Therefore in the mid of 2025, the European Commission organized a meeting on simplification of CLP regulations, the purpose of which would be to reduce the burden on companies. The talks concluded with the publication of proposals for simplifications regarding the CLP Regulation, which include:

• digitization of information through the introduction of digital contact
• labelling claims – withdrawal of minimum font size and formatting rules, leaving the obligation to update the label “without any delay”, simplification for small packages
• product advertisement must include the phrase: “‘Always read the label and product information before use’, instead of full information about the risks of CLP
• extension of transitional periods

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2024/2865 as regards dates of application and transitional provisions

Changes in deadlines in relation to Regulation (EU) 2024.2865 include:

• deletion of Article 1 points (14), (26), (27), and parts of Annex II from the effective date from 1 July 2026
• deletion of Article 1 point (15c), Annex II point (2),(3) from the effective date from 1 January 2027
• addition of a third transitional period falling on 1 January 2028 and transfer of obligations under the above-deleted articles
• addition of a transition period to sell out of stock for products with the “old label”

The proposal amends Article 2 of the Regulation (EU) 2024/2865 that sets the dates of entry into force and entry into application of the provisions of that Regulation:

Transition periods for stock-out:

Substances and mixtures that were placed on the market after the entry into force of the regulation can remain on the market with the “old” label for up to 35 months from the date of entry into force of the Omnibus.

Effective dates of additional provisions:

Provisions introducing “digital contact” – 36 months from the entry into force of the Omnibus.

Link: https://single-market-economy.ec.europa.eu/publications/simplification-certain-requirements-and-procedures-chemical-products_en

Omnibus Chemicals Simplicity Package: https://ekotox.eu/news/omnibus-chemicals-simplicity-package/
Amendments to the annexes to the Cosmetics Regulation: https://ekotox.eu/news/amendments-to-the-annexes-to-the-cosmetics-regulation/

As part of the concluded negotiations, the content of the updated detergents regulation was agreed. The official publication of the content is planned for the turn of 2025/2026.

Regulation (EC) No 648/2004 on detergents provides a harmonised framework for the marketing and use of detergents and surfactants throughout the European Union. As part of the work on the revision of the detergents regulation, a compromise text was agreed.

The most important areas of the new content of the Detergents Regulation are listed below:

Product documentation and notifications to ECHA

• Obligation to submit an Ingredient Data Sheet (IDS) electronically to ECHA, in a language easily understood by designated national authorities for all detergents and surfactants used by consumers (including those not classified as hazardous)
• The dossier must include: product name, UFI code, list of all intentionally added substances, product label template.
• The additional delegated act would specify the format, a list of detailed information or the conditions for updating the notification.

Detergent dosing and label elements

• Introduction of detailed labelling elements for dosing, not only for laundry detergents, but also for consumer surface cleaners.
• The label must include: dilution information; the amount of product that can be applied to the surface; additional instructions to limit excessive use of the product.
• Entering units of measurement in: milliliters, grams or number of units/pieces
• Marking the measuring cup for dosing in milliliters or grams, as well as adding permanent information about the corresponding product dosage depending on the water hardness.

Labelling and marking

• The label must include:
• the name of the product,
• contact details of the manufacturer,
• instructions for use of the product,
• detergent content
• UFI code
• list of preservatives
• indication of the intended use of the product, e.g. product for professional use only
• It is permissible to use digital labelling as an additional form of marking, which does not exempt from mandatory elements to be placed on the physical label.

Digital Product Passport

• Before placing a product on the market, a digital product passport (DPP) must be prepared, which contains the mandatory information set out in Annex VI, Part A, and may contain additional information as set out in Annex VI, Part B, and reported to the Union Registry, which will assign a product registration number.
• The DPP must be linked to a data carrier, e.g. a QR code printed on the label or packaging of the product, or attached to the documentation if the product is sold in bulk.
• The DPP must be available for 10 years from the date the product was last placed on the market or ceased to operate.
• The implementing act is to contain detailed data on the introduction and specificity of the DPP.

Biodegradation of surfactants

• They must meet the criteria set out in Annex I A.
• Products in foil (e.g. laundry capsules) and products with the addition of organic substances ≥ 10% of the above-mentioned substances must meet new biodegradability criteria, which will be established in a delegated act.
• In justified cases, it is possible to apply for derogations from the biodegradability criteria.

Phosphorus content

• Phosphorus limits of < 0.5 g for consumer detergents and <0.3 g for automatic dishwashers.
• The Commission plans to work further on the assessment of the phosphorus reduction and the extension of the restriction to other categories.

Microorganism-based products

• Define microbiological cleaning products and develop requirements for this product category.
• Introduction of a mandatory risk assessment of microbiological products, based on the methodology developed in the subsequent delegated act.

No animal testing

• Introduction of a general ban on animal testing of detergents in favour of a new approach methodology.
• Allowing the use of archival data obtained during animal studies carried out before the entry into force of the regulation.

Refill station

• Provide a physical label and a digitally labeled data carrier for each refilled package.
• Implement risk mitigation measures.

Introducing the role of the authorised representative in the EU

• An operator wishing to place products on the EU market must appoint an authorised representative in the EU to act on behalf of the manufacturer.
• Importers of products from outside the EU can automatically become the responsible party for the product and its compliance within the EU.

The agreed text will now go through the formal approval procedure, so there may still be minor changes to it. The official publication of the detergent regulation in the Official Journal of the EU is planned for the end of 2025 or the beginning of 2026, and the application date for new regulations are expected in mid-2029.

Source: Newsletter AISE: https://aise.eu/

Ekotox Website: https://ekotox.eu/detergents-and-sufactants/

The European Commission has presented another package simplifying regulations covering the chemical sector. The simplifications concern chemical regulations in the cosmetics and fertilizers sector, as well as the method of labelling, advertising or selling chemicals.

On 08.07.2025, the European Commission published the sixth Omnibus called the European Action Plan for the Chemical Industry. The aim of the Omnibus is to reduce bureaucracy, reduce costs for industry, invest in sustainable development, and stimulate growth in global competitiveness.

The main objectives of the simplification idea include:

• creation of a “Critical Chemical Alliance” to monitor the supply chain of critical raw materials
• expanding the monitoring of imports of chemicals
• reducing energy costs through investments in hydrogen and recycling
• implementing a circular economy and increasing the recycling of raw materials
• authorisation of the use of PFAS substances in strategic sectors

Specific issues for the chemical sector included in the sixth Omnibus:

Changes in the CLP Regulation:

• digitization of information through the introduction of “digital contact”
• simplifications for labelling – withdrawal of minimum font size and formatting rules, leaving the obligation to update the label “without undue delay”, simplifications for small packages
• product advertisement must include the phrase: ‘Always read the label and product information before use’, instead of full information about the risks of CLP
• introduction of a transitional period i.e. for the labelling of dangerous products produced before the entry into force of the new legal act, in the online sale description

Changes in the Cosmetic Products Regulation

• authorisation of the use of CMR substances in cosmetic products after application for a derogation, when certain conditions are met

Changes in the Fertilising Products Regulation

• digitization of information through the introduction of digital contact
• the introduction of a digital declaration of conformity and a cross-reference attached to the product that provides easy access to the digital declaration of conformity and the information contained therein; in an appropriate format in accordance with Directive (EU) 2019/1024
• storing all information confirming the conformity of the product in digital form, in a language easily understood by the inspectorate

The proposed Omnibus package raises some doubts about maintaining the safety and health of consumers at an appropriate level, as well as care for the environment. However, it is a great relief for entrepreneurs and also contributes to weakening the decline in the competitiveness of EU chemical products.

Source: https://single-market-economy.ec.europa.eu/publications/simplification-certain-requirements-and-procedures-chemical-products_en

Concerns related to the proposed simplification

The proposed Omnibus package raises some doubts about maintaining the safety and health of consumers at an appropriate level, as well as care for the environment. Environmental activists warn that simplifying the rules could undermine years of progress in the field of health and environmental protection. In addition, they said that the European Commission is succumbing to pressure from industry and taking the side of entrepreneurs, not consumers.

Proponents of simplification argue that the proposed plan is not only a policy on chemicals, but a real support for the industry, which has been alarming for so long. They highlight the problems with maintaining competitiveness on the global market due to too high regulatory burdens. Proponents cite the example of the decline in the importance of the chemicals sector in Europe by almost half in the last 20 years, as well as the closure of many chemical plants and the relocation of production outside the European Union.

Opinions are divided, and the proposed documents are only a draft presented by the European Commission. To be officially implemented they must go through the entire legislative procedure with approval by the EU Council and the European Parliament.

The Commission’s replies to the questions:

Why introduce a simplification package into recently updated rules (e.g. CLP)?

• Because chemicals are crucial to the EU economy and the chemical industry is facing high energy costs, unfair competition and weak demand. Large companies are closing down and moving their productions outside the European Union. The simplification package aims to help the chemical sector recover and increase the production of chemicals, as well as cut red tape to reduce costs.

In addition to regulatory simplification, will the Commission implement other measures for the chemical sector?

• Import activities will be strengthened through the creation of an Import Surveillance Task Force. Enforcement of chemicals legislation will be a priority. Activities will focus in particular on online sales through online platforms and the sale of products through unregulated intermediaries. The purpose of the inspection is to reduce legal loopholes and eliminate imported products that do not comply with the regulations.
• In addition, in order to secure access to critical raw materials, a “Critical Chemicals Alliance” will be established to identify critical chemicals, establish a common purchasing base for critical chemicals, and diversify the sources of critical raw material suppliers.
• The Commission intends to focus on the recycling of chemicals, in particular plastic recycling, and to develop methods for calculating, checking and reporting the plastic content of single-use bottles.
• The European Chemicals Agency will undergo a reform and be given more flexibility to deliver faster scientific advice and clarify the rules on chemicals to the industry.

Source: qanda-25-1759_en.pdf

Ekotox website: https://ekotox.eu/

Companies applying for renewal of approvals of BPR active substances from 1 July 2026 can only submit applications in the IUCLID format. Entrepreneurs must prepare for the development of documentation in an appropriate format.

In accordance with Article 79 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, applications for approval of an active substance for use in biocidal products must be submitted in the format of the International Uniform Chemical Information Database – IUCLID. Despite the provisions of Article 79, in practice it was accepted to provide other data formats for active substances covered by the Review Programme.

In order to ensure compliance with the format and provisions of Regulation (EU) 528/2012, the European Chemicals Agency has informed that from 1 July 2026, all applications for renewal of approvals of an active substance for use in biocidal products must be submitted in the IUCLID format.

What does this mean for entrepreneurs?

All data, including information from the initial application for marketing authorisation of the active substance, must be compiled and submitted in IUCLID format.

*Ekotox Centers provides services of dossier preparation for active substances and biocidal products in the IUCLID format.

Webiste ECHA: All news – ECHA
Webiste Ekotox: https://ekotox.eu/biocides/
REACH Conference 2025: https://ekotoxtraining.com/events/reach-conference-2025/