L'articolo Vitafoods 2026 proviene da ChemSafe.

Each member, or company, can participate according to their needs, as Holder of the Main Registration or as Holder of a Same Biocidal Product Registration.
The idea is of a collaboration between companies that preserves the uniqueness and the ability to independently manage their business.

Advantages of Joining a Task Force

Companies that join the consortium share costs for testing, chemical and toxicological studies, data generation, and regulatory compliance.

In detail, by joining a biocide Task Force you:

• Share costs to develop Data and Dossier.
• Outsource BPR Project Management.
• Get involved in collaborative decision discussions.

Regulatory firms make sure that everything is carried out correctly and operates for the common interest of the task force.

Ethanol Task Force Chemsafe

Chemsafe is creating an international Ethanol Task Force and handles the coordination of the BPR project, giving you an opportunity to reduce regulatory effort and focus on what matters most, your business!

By joining a Chemsafe-coordinated Biocide Task Force, companies collaborate to develop the necessary data and registration dossiers while sharing costs and expertise.
Contact us now to learn more about this opportunity.

L'articolo Biocide Task Force: how to make your Regulatory Life easy proviene da ChemSafe.

UK-EU SPS Alignment for PPPS & Biocides

The new UK-EU SPS Agreement (targeted for mid-2027) marks a definitive return to regulatory alignment for the agri-chemical and biocide sectors. For industry professionals, this means a shift back toward harmonized standards to eliminate border friction and dual-authorization costs.

The agreement centers on alignment with:

•     Regulation (EC) No 1107/2009: Re-aligning active substance approvals and authorizations for Plant Protection Products (PPPs).
•     Regulation (EC) No 396/2005: Harmonizing Maximum Residue Levels (MRLs) for food and feed—a prerequisite for removing Export Health Certificates.
•     Regulation (EU) No 528/2012 (BPR): Bringing Biocidal Products back into a unified framework for active substance approvals and product authorizations.

Operational Implications

•     End of Divergence: Minimizing the “double-regulation” burden for companies operating in both GB and EU markets.
•     Market Access: Re-opening the EU market for products currently blocked by divergent MRLs or substance approvals.
•     Technical Guidance: Starting May 2026, Defra will provide detailed guidance, but a “reset” for substances diverged since 2021 is expected.

Defra has launched a Call for Information to ensure the implementation strategy reflects industry reality. This is your opportunity to influence:

•     Targeted Transitional Arrangements: Identifying sectors that require more time or specific support.
•     Practical Guidance: Defining the technical checklists and tools needed for a smooth Day 1.

The exact details and timing remain subject to ongoing discussions with the EU, making your feedback vital to the negotiation and implementation phases.

Source: https://www.gov.uk/government/news/uk-eu-sps-agreement-legislation-in-scope

CHEMICAL:

Regulation EU 2026/405: New Detergents and Surfactants Compliance

The new regulation on detergents and surfactants has been published on March 2, 2026.
The new Reg. (EU) 2026/405 repeals Reg. (CE) 648/2004 and addresses weaknesses and areas not covered by the previous regulation.

This long-awaited Regulation clarifies existing rules to facilitate business, assist consumers, reinforce market surveillance, and provide a high level of protection for human health and the environment.

Important innovations:

– digitalization of information (e.g. digital product passport and digital labeling)
– development of detergents containing micro-organisms;
– encouragement of refill sales;
– extension of biodegradability criteria to water-soluble polymer films and other organic substances;
– prohibition of animal testing, favoring alternative methods;
– introduction of an authorized representative for non-EU manufacturers for specific tasks.

The regulation (EU) 2026/405 shall enter into force on March 22, 2026 and shall apply from 23 September 2029, giving companies a transition period to comply.

ECHA:

ECHA Supports PFAS Restriction with Targeted Derogations

ECHA has confirmed its support for a broad EU restriction on per- and polyfluoroalkyl substances (PFAS) under the REACH Regulation, while proposing a series of targeted derogations for specific uses where alternatives are not yet available. At the same time, it is proposing a range of specific derogations for the substances’ use in certain areas where alternatives are not yet available.

The proposal was first submitted by five countries in Europe: Denmark, Germany, the Netherlands, Norway, and Sweden.
The aim of the proposal is to restrict the use of these substances in the EU market. The substances in question have the reputation of being extremely persistent in the environment. The term ‘forever chemicals’ is used to refer to these substances. They have the reputation of being extremely difficult and costly to decontaminate.

To ensure the measure remains proportionate, ECHA’s assessment considers time-limited derogations for certain applications where PFAS alternatives are currently not technically or economically feasible. These exemptions would allow continued use under specific conditions while industries transition toward safer substitutes.

ECHA’s scientific committees are continuing their evaluation of the restriction proposal. Their final opinions are expected by the end of 2026, after which the European Commission will decide on the adoption of the restriction.

Source: https://echa.europa.eu/it/-/echa-supports-pfas-restriction-with-targeted-derogations

REACH:

Based on the Member State Committee’s opinion, we adopted and published the Community Rolling Action Plan (CoRAP) for 2026-2028 on 24 March 2026.

States plan to evaluate 17 substances in 2026, while 10 are listed for 2027 and 2028.
The evaluation must be risk-based and it allows Member States to request information exceeding standard requirements. Member

Registrants who need to update their dossiers with new relevant information such as hazard, tonnages, use and exposure, can follow this guide for advice.

ECHA has launched 54 new consultations on testing proposals.
Have your say until 8 May 2026.

Source:https://echa.europa.eu/documents/10162/17221/fs_substance_evaluation_en.pdf

L'articolo March Regulatory Updates proviene da ChemSafe.

L'articolo Interclean 2026 proviene da ChemSafe.

Role of Materials in Extractables and Leachables Risk

Materials used in container closure systems, packaging components, and manufacturing equipment are primary sources of extractables and leachables. Polymers, elastomers, inks, adhesives, and coatings may contain additives, processing aids, or degradation products that can migrate into the drug product.

ICH Q3E requires that material composition and performance are sufficiently understood to support a robust risk assessment. Variability in these materials, even when nominally equivalent, can lead to differences in chemical profiles that must be evaluated and controlled.

Supply Chain Complexity and Transparency

Modern pharmaceutical supply chains are often global and multi-tiered, involving raw material manufacturers, component suppliers, converters, and assemblers. This complexity can limit transparency into material composition and manufacturing processes.

ICH Q3E increases expectations for supply chain knowledge, including access to detailed material information and change notification mechanisms. Limited visibility or reliance on proprietary information can complicate extractables assessments and challenge the robustness of risk justifications.

Impact of Supplier Changes and Material Modifications

Changes in suppliers or manufacturing sites are a common source of material variability. Even when materials meet the same specifications, differences in formulation, processing conditions, or quality controls may alter the extractables profile.

ICH Q3E requires these changes to be evaluated through formal change management and risk assessment processes. In some cases, bridging studies or additional analytical testing may be needed to demonstrate that the E&L risk remains acceptable, increasing both timelines and resource requirements.

Batch-to-Batch Variability and Process Controls

Material variability is not limited to supplier changes. Batch-to-batch variability within the same supplier can also influence extractables levels, particularly for polymer-based materials. Factors such as raw material sourcing, curing conditions, or aging can introduce subtle but relevant differences.

ICH Q3E encourages manufacturers to consider this variability when designing extractables studies and setting control strategies. Reliance on a single study without consideration of manufacturing variability may not provide sufficient assurance of product safety over time.

Lifecycle Management and Ongoing Monitoring

Supply chain and material variability are dynamic by nature, making lifecycle management a key consideration under ICH Q3E. Risk assessments performed during development must be periodically reviewed to account for changes in materials, suppliers, or product use conditions.

Ongoing monitoring, including trend analysis and periodic re-evaluation of E&L risks, supports early identification of emerging issues. This lifecycle approach aligns with broader ICH quality principles and reinforces the need for integration between development, quality, and procurement functions.

Supplier Quality Agreements and Communication

Effective management of material variability under ICH Q3E depends heavily on strong supplier relationships. Quality agreements should clearly define expectations for material characterization, change notification, and documentation.

Proactive communication with suppliers enables timely assessment of proposed changes and reduces the risk of unanticipated impacts on the E&L profile. Inadequate agreements or delayed notifications can result in compliance gaps and regulatory risk.

Regulatory Expectations and Inspection Focus

Regulatory authorities increasingly expect companies to demonstrate control over supply chain variability as part of ICH Q3E compliance. During inspections, assessors may focus on how material changes are identified, assessed, and documented, as well as the scientific rationale supporting decisions not to perform additional testing.

A well-documented, risk-based approach is essential to justify the management of material variability and to demonstrate that patient safety remains protected.

Supply chain and material variability represent a central challenge in the practical implementation of ICH Q3E. The guideline requires pharmaceutical companies to move beyond static assessments and adopt a dynamic, lifecycle-based approach to material control. By enhancing supply chain transparency, strengthening supplier governance, and integrating E&L considerations into change management processes, organizations can effectively manage variability while maintaining regulatory compliance and safeguarding patient safety.

Discover our services to find your solution!

L'articolo ICH Q3E: E&L risks with Material Variability and Supply Chain proviene da ChemSafe.

Today, regulators and notified bodies expect a science-based understanding of materials, their chemical composition, and their behavior during manufacturing and sterilization. In other words, biological safety can no longer rely solely on a certificate.

From “Material Certification” to Chemical Characterization

Manufacturers are increasingly expected to identify and understand:

• Additives and stabilizers.
• Catalysts and polymerization residues.
• Antioxidants and processing aids.
• Contaminants and impurities.
• Degradation products generated during manufacturing or sterilization.

The End of “Black Box Testing”

Another significant change in the ISO 10993 standard is the emphasis on the final configuration of the device rather than the raw material.
It was common to assume in the past that if the raw polymer was certified, the final component woulkd be safe, however, this assumption is no longer valid.

Medical device manufacturers must evaluate how manufacturing processes affect material chemistry, including:

• Injection molding.
• Extrusion processes.
• Surface treatments or coatings.
• Adhesives and bonding agents.
• Sterilization processes.

Sterilization methods such as gamma irradiation, ethylene oxide (EtO), and vaporized hydrogen peroxide (VHP) can significantly alter the chemistry of polymers and potentially generate new extractables or degradation products.

This is why the ISO 10993 framework now emphasizes extractable and leachable studies, stability assessments, and aging simulations.
Understanding how a material behaves after processing and sterilization is essential for demonstrating safety.

Risk Assessment Instead of Animal Testing

The modern approach promoted by ISO 10993-1 encourages manufacturers to minimize animal testing whenever possible.

The evaluation follows a risk-based strategy combining:

1. Chemical characterization (ISO 10993-18).
2. Toxicological risk assessment (ISO 10993-17).
3. Existing scientific data.

The process works as follows:

1. Identify substances that may migrate from the material.
2. Estimate patient exposure.
3. Compare exposure with established toxicological thresholds.

If the calculated risk is acceptable, then further animal testing may not be necessary.
This approach not only has ethical benefits but also allows for a more scientifically informed approach to material safety.

The New Concept of “Reasonably Foreseeable Misuse”

The latest updates in the ISO 10993 framework also introduce a broader view of risk evaluation.
Manufacturers must consider not only the intended use of a device or packaging system, but also scenarios of reasonably foreseeable misuse.

Examples include:

• Storage outside recommended temperature conditions.
• Longer shelf life than expected.
• Contact with unintended substances.
• Variations during transport or sterilization cycles.

These factors can affect the chemical stability of materials and therefore must be considered during the biological evaluation process.

What This Means for Medical Device Manufacturers

For companies in the business of designing medical devices, components, or packaging, USP Class VI certification is not a viable approach anymore, at least as a standalone approach.

Companies should focus on ensuring their materials have been:

• Chemical characterization data compliant with ISO 10993-18.
• Toxicological risk assessments according to ISO 10993-17.
• Extractables and leachables studies.
• Stability and aging data after sterilization.
• Full understanding of the material formulation.

These elements form the scientific basis of the Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) required during regulatory submissions.

Conclusion

The evolution of the ISO 10993 framework reflects a fundamental shift in how biocompatibility and material safety are assessed in medical devices.
The industry is moving away from simple material certification toward a deeper understanding of chemical composition, processing effects, and toxicological risk.For manufacturers, this means that material selection is no longer just a procurement decision, it is a regulatory strategy.

Working with experts in toxicology, chemical characterization, and regulatory affairs can significantly reduce risks during product development and streamline the path to regulatory approval. Contact us to learn more about how we can help you and be your partner.

L'articolo USP Class VI: New Approach to Polymer Safety in Medical Devices proviene da ChemSafe.

What is a Novel Food in the EU?

Under Regulation (EU) 2015/2283, a food or ingredient is considered Novel Food if it was not consumed to a significant degree in the European Union before May 15, 1997.
The regulation covers various categories of foods and ingredients, including those derived from new sources, produced through innovative processes, or newly introduced into the food supply. When a product falls under this definition, it must undergo a pre-market authorization process before being placed on the EU market.

Can an ingredient be Novel Food and Non-novel in food supplements?

Yes, this situation does occur. In some cases, an ingredient may require Novel Food authorization for use in conventional foods but not for use in food supplements.
This regulatory status is sometimes described as “Novel Food – non-novel in food supplements.”
The reason lies in the intended use and historical consumption patterns associated with different product categories.

Why does this distinction exist?

Although food supplements fall within the general definition of food, regulators recognize that they represent a specific category with unique characteristics.
According to EU regulation, food supplements are concentrated sources of nutrients or other substances with nutritional or physiological effects, typically marketed in dose form such as capsules, tablets, or measured liquids, with the purpose of supplementing the normal diet.

Due to their nature, food supplements are typically consumed in controlled quantities and often targeted to specific population groups, whereas conventional foods are generally consumed more broadly across all age groups and dietary patterns. Consequently, it is possible for an ingredient to demonstrate a documented history of consumption in food supplement form even if there is limited or no evidence of significant consumption as a conventional food prior to 15 May 1997.

This distinction is also reflected in several national botanical lists across EU Member States, such as the BELFRIT list or national inventories of plants permitted in supplements.

Where can I find examples?

Examples of ingredients with this regulatory status can be found in the EU Novel Food Catalogue, which provides guidance on the Novel Food status of many substances and ingredients used in the food sector. Examples are Maqui berries, Sour cherry seeds and Aqueous extract from fig leaves.

How can you determine the status of your ingredient?

Identifying whether an ingredient is Novel Food, or potentially not novel in food supplements, requires a detailed regulatory evaluation.
This typically involves assessing historical consumption, reviewing regulatory databases, analyzing production processes, and considering the intended use of the ingredient.

When uncertainty remains, companies may initiate a Novel Food status consultation under Article 4 of Regulation (EU) 2015/2283 with a competent authority.

Final takeaway

Understanding whether an ingredient is Novel Food, non-novel, or “non-novel in food supplements” is a crucial step for companies planning to enter the European market.
At Chemsafe, we support companies through Novel Food status assessments, regulatory strategy development, and Article 4 consultations, helping you determine the correct regulatory pathway for your ingredient and ensure compliance with EU requirements.
Are you unsure about the status of your product? Contact us! Our experts can assist you with a preliminary regulatory evaluation and the full Novel Food consultation process.

L'articolo Novel Food in Ingredients and Food Supplements: Key Differences proviene da ChemSafe.

The aim of the legislation is to promote sustainability, benefiting both the environment and consumers.

What changes with Reg. EU 2026/405?

The revised Regulation clarifies existing rules with the aim of assisting consumers, reinforcing market surveillance and providing a high level of protection for human health and the environment. The obligations and adjustments brought by the new regulation are:

• Broader definition of “detergent”

In order to include newly developed detergents, this Directive extends the definition of “detergent”. This particularly concerns products containing intentionally added microorganisms, as well as products supporting the cleaning process when used tigether with a detergent (example: products that modify the odor of fabrics).

• Regulation of new markets

The new Regulation takes into account new market developments, focusing on detergents containing micro-organisms.
These latter need clear taxonomic identification, safety testing and the development of a harmonised risk assessment methodology by the Commission.
Detergents supplied via refill systems now have an established regulatory framework.

• New biodegradability requirements

Surfactants shall be completely biodegradable, both in their intended use alone as well as in detergents.
Criteria for biodegradability shall apply to water-soluble polymer films used in detergent capsules by 2032. In addition, the criteria shall apply to all polymers in the films by 2032.
Later, by 2034, criteria shall apply to other organic substances used at concentrations of 10% w/w or higher.

• Enabling the digital transition – Digital Product Passport (DPP)

The number of products selling on the web is increasing, so digitisation efforts must be stepped up in line with the Union’s overall objectives.
The Digital Product Passport (DPP) has been introduced for this reason.

The DPP is a digital labelling providing all useful product information. It needs to show the package’s image, the complete list of ingredients and micro-organisms, and traceability data, in a single digital space. This will help strengthen transparency, traceability and accessibility of information along the entire supply chain.

Who affects Reg. EU 2026/405?

The new EU regulation on detergents and surfactants affects:

1. Manufacturers: must adapt formulations, labeling, technical documentation, biodegradability requirements, and digital information systems. In particular, those who produce detergents containing microorganisms, or who use water-soluble capsules, or who must implement the new Digital Product Passport will be impacted.
2. Importers: They are responsible for the product’s compliance with European requirements before marketing.
3. Distributors: They must verify that the products sold are compliant and correctly labeled.

When is the regulation becoming mandatory?

Detergents and surfactants on the market before September 23, 2029, and fulfilling the requirements of the Regulation (EC) No 648/2004 shall be made available on the market without time limits. In the meantime, detergents and surfactants marketed after September 22, 2029, and before September 23, 2030 , shall be made available on the market until September 23, 2030 , taking into consideration that the products will be compliant with the Regulation (EC) No 648/2004.

L'articolo Regulation EU 2026/405: New Detergents and Surfactants Compliance proviene da ChemSafe.

BPC approves Ethanol use for disinfectants and hand sanitizers

On February 24 in Helsinki, the Biocidal Products Committee (BPC) of the European Chemicals Agency (ECHA) concluded that ethanol can be approved for use in general disinfectants and hand sanitizers.

The favorable opinion covers three product categories:

• PT 1: Human hygiene (e.g., hand sanitizers)
• PT 2: Surface disinfectants (both for civil and industrial use)
• PT 4: Food and feed sector

The Committee confirmed that the use is safe but did not take a final position on the classification of ethanol as a carcinogenic or reprotoxic substance as specific data on skin exposure is lacking.

Following the adoption of the BPC, ECHA will send its opinion to the European Commission for a final decision.
Once the approval regulation has been published, the technical deadlines for authorization applications will begin.

Source: https://echa.europa.eu/it/-/echa-s-biocides-committee-supports-approval-of-ethanol-in-disinfectants

CHEMICAL:

ECHA adds two hazardous chemicals to the Candidate List

The Candidate List of substances of very high concern (SVHC) now contains 253 entries for chemicals that can harm people or the environment.

On February 4, two new substances were added to the Candidate List of substances of very high concern (SVHC):

• n-hexane (EC 203-777-6, CAS 110-54-3)
• 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and its salts (EC -, CAS -).

These two substence are used in formulation, polymer processing, coatings, cleaning agents and as process regulators and cross-linking agents respectively.
Companies and importers are responsible for managing the risks of these chemicals and giving both customers and consumers information on their safe use.

Source: https://echa.europa.eu/-/echa-adds-two-hazardous-chemicals-to-the-candidate-list-1#msdynmkt_trackingcontext=5f81ce37-885f-48d6-ab67-4a7e35320200

CLP:

New intentions and proposals to harmonize classification and labelling

The Registry of Classification and Labelling (CLH) intentions until outcome compiles all submissions received by ECHA relating to new or updated harmonized classifications and labelling of substances.

Three intensions have been submitted during February 2026 for:

• Bis(isopropyl)naphthalene (EC 254-052-6, CAS 38640-62-9)
• 2-[8-chloro-4-(4-methoxyphenyl)-3-oxo-quinoxaline-2-carbonyl]cyclohexane-1,3-dione (EC -, CAS 1342891-70-6)
• 2,2,2-trifluoroethanol (EC 200-913-6, CAS 75-89-8).

Additionally, a proposal has been submitted for:

• di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide; 1,1-bis(tert-butylperoxy)-3,3,5-trimethylcyclohexane (EC 229-782-3, CAS 6731-36-8).

Source: https://echa.europa.eu/it/registry-of-clh-intentions-until-outcome

REACH:

Consultation Launched on Adding Four Substances to the REACH Authorisation List

On February 2, 2026, ECHA opened a public consultation on a draft recommendation to include four substances into the REACH Authorization List (Annex XIV):

• Bumetrizole (UV-326) (EC 223-445-4)
• UV-329 – 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol (EC 221-573-5)
• Triphenyl phosphate (EC 204-112-2)
• 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one (EC 438-340-0)

ECHA is now looking for further information regarding the uses and the volumes of these substances, their possible exemptions from the authorization requirement and on the structure and complexity of the supply chains.

Registrant users are invited to ensure that the information of their REACH registration dossiers are up to date.
Have your say until 2 May 2026.

Source: https://echa.europa.eu/it/-/echa-consults-on-recommending-four-substances-for-reach-authorisation#msdynmkt_trackingcontext=c72c2cdb-b7b3-4a8b-8782-d993adb80000

FOOD:

EFSA: Exploring new opportunities to anticipate emerging challenges in chemical risk assessment

The European Food Safety Authority has released a new supporting report that highlights important gaps in monitoring and surveillance data that need to be addressed for future chemical risk assessments in the EU.

Key takeaways:

• The report maps available data sources across multiple chemical groups, including pesticides, contaminants, food additives, and food contact materials.
• EFSA identified 44 data gaps, with 21 considered high priority for improving risk assessment quality.
• Major challenges mainly include fragmented data sources, limited interoperability, restricted access to private data, and uneven geographic coverage.

Robust, harmonized monitoring data are essential to support science-based regulatory decisions, improve exposure assessments, and strengthen protection of human health, animal health, and the environment.

The report highlights the need to improve data generation, harmonization, and sharing, with the aim of supporting EFSA’s future risk assessment activities.

Source: https://efsa.onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2026.EN-9937

L'articolo February Regulatory Updates proviene da ChemSafe.

L'articolo NJFPA 2026 Annual Conference proviene da ChemSafe.