What Is a Synthetic Polymer Microparticle Under EU Law?

The REACH regulation does not concern all plastic particles available on the market;  its scope, as defined in Entry 78 of Annex XVII, is limited to synthetic polymer microparticles (SPM) that are intentionally added to a substance or mixture to confer a specific, sought-after characteristic.

An SPM is a solid polymer making up at least 1% of a particle’s weight, where at least 1% of those particles have all dimensions of 5 mm or less, or, for fibres, a length of 15 mm or less with a length-to-diameter ratio above 3. Natural, biodegradable, water-soluble and carbon-free polymers are excluded from the designation, as clarified in the European Commission’s Explanatory Guide to Entry 78.

This distinction is central to the restriction: where SPM presence results from the unintentional breakdown of a larger plastic object, Entry 78 simply does not apply, as the Commission’s implementation guidance makes explicit.

The EU Regulatory Framework: REACH Annex XVII, Entry 78

The legal response sits within REACH. Entry 78 of Annex XVII prohibits the placing on the market of SPM, on their own or in mixtures, above a concentration of 0.01% by weight, unless a specific derogation applies. The European Commission’s implementation guidance describes it as the broadest restriction adopted under REACH to date, both in scope and expected impact. In vitro diagnostic devices face only delayed information duties from 17 October 2026, per ECHA’s reporting guidance.

Medical devices placed on the market as a substance or mixture under Regulation (EU) 2017/745 (MDR), by contrast, benefit only from a transitional derogation until October 17, 2029. A further correcting act, Commission Regulation (EU) 2026/1168, has since clarified the scope of these derogations, including for particles permanently bound in a solid matrix, with certain solid-matrix applications requiring re-assessment before June 22, 2028.

A Related but Distinct Restriction: Silicones (D4, D5, D6)

Silicone-based materials generally sit outside Entry 78, since polymers such as polydimethylsiloxane do not typically take the solid, particulate form the SPM definition requires.
A separate REACH restriction is nonetheless directly relevant to silicone medical devices. Commission Regulation (EU) 2024/1328 amended Entry 70 of Annex XVII to restrict three cyclic siloxanes — octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) — on persistence and bioaccumulation grounds unrelated to particle size.
Crucially for this industry, the same act includes a specific derogation allowing D5 and D6 to be placed on the market in devices under Regulation (EU) 2017/745 intended for the treatment and care of scars and wounds, wound prevention, and stoma care, an exemption that remains available until June 6, 2031.

What This Means for Manufacturers

Falling under an exemption does not mean falling outside the regulation. Where release cannot be excluded, manufacturers must provide instructions for safe use and disposal, submit annual estimates of released SPM quantities, with reporting obligations formalised through the ECHA reporting system published in April 2025, and keep technical documentation demonstrating eligibility for any derogation used. With the 2029 MDR deadline and the 2031 siloxane deadline both approaching, the compliance runway is shorter than it appears.

How We Can Help

Navigating overlapping REACH, MDR and IVDR requirements, mapping polymer and siloxane content across a device portfolio, and building defensible technical documentation demands both regulatory expertise and a solid toxicological understanding of particle and substance behaviour.

This is precisely where our team supports medical device manufacturers: material compliance gap analysis, derogation eligibility assessments and reporting strategy. If microplastics or restricted siloxanes are part of your device’s material profile, get in touch — we can help you turn these regulatory deadlines into a managed, documented process.

• Commission Regulation (EU) 2023/2055
• Regulation (EU) 2017/746 (IVDR)
• Regulation (EU) 2017/745 (MDR)
• Commission Regulation (EU) 2024/1328
• ECHA — Hot Topics: Microplastics

Contact us to create a compliance srategy and get ahead of Microplastics restriction.

L'articolo EU Microplastics Restriction: Impact on Medical Devices proviene da ChemSafe.

PPWR Key Requirements application from August 12, 2026

The EU Packaging and Packaging Waste Regulation (PPWR), Reg. (EU) 2025/40, has introduced new requirements to reduce packaging waste, improve recyclability and reuse, and support the transition towards a circular economy.

From August 12, 2026, key requirements include:

• Restrictions on lead, cadmium, mercury and hexavalent chromium in packaging.
• Minimization of substances of concern (SoCs) in packaging materials and components.
• New obligations for manufacturers and importers, including packaging identification, traceability, conformity assessment and technical documentation.
• Restrictions on PFAS in food-contact packaging, subject to specified concentration limits.

Further requirements will be progressively introduced:

– 2029: 90% separate collection target for plastic beverage bottles and metal beverage cans.
– 2030: Design-for-recycling requirements, recycled-content targets for plastic packaging and initial reuse targets.
– 2035: Packaging needs to prove recyclability on a mass scale.
– 2040: Higher recycled-content and reuse targets will come into force.

The PPWR will therefore progressively reshape how packaging is designed, manufactured, labelled, collected, reused and recycled across the EU.
For businesses placing packaging on the EU market, assessing materials, supply chains and compliance requirements will be essential to prepare for the upcoming deadlines.

Source: https://environment.ec.europa.eu/topics/waste-and-recycling/packaging-waste_en

FDA Proposes Mandatory GRAS Notifications for Food Substances

The U.S. Food and Drug Administration (FDA) has proposed a major revision of the Generally Recognized as Safe (GRAS) framework.
The proposal was published on August 11, 2026, in the Federal Register. Comments are due by December 9, 2026.

The key changes that have substantial implications for the food industry include:

• The exiting voluntary GRAS notification program would become mandatory.
• Companies introducing substances under the GRAS provision would generally need to notify FDA and provide the scientific basis supporting their GRAS conclusion.
• The requirement would apply on substances already used in food as well as those introduced for food use for the first time, subject to specified exceptions.
• A time-limited streamlined submission pathway is proposed for certain substances already in interstate commerce.
• The framework would cover both direct food ingredients and indirect uses, including food contact substances.

 This could significantly increase FDA oversight and transparency around GRAS conclusions, if finalized. It would require companies to ensure that safety determinations are scientifically supported and appropriately documented.
The proposal represents a substantial change for companies relying on independent or voluntary GRAS notice to market food substances in the United States.

Source: https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/substances-generally-recognized-safe-proposed-rule

Medical Devices:

ISO 10993-3:2026

Published on August 6, 2026, the updated ISO 10993-3 replaces the 2014 edition for the biological evaluation of medical devices.

The updated standard focuses on:

• Long-Term Safety, by introducing revised requirements for evaluating genotoxicity, carcinogenicity, reproductive, and developmental toxicity.
• Risk-Based Approach, as the standard emphasizes integration with chemical characterization and toxicological risk assessment to minimize unnecessary testing.
• Manufacturer Action, as companies must update their Biological Evaluation Plans (BEP) for long-term and implantable devices to ensure compliance.

Source: https://www.iso.org/standard/10993-3

CLP:

European Commission Proposes CLP Update to Align with Latest GHS Rules

The European Commission is proposing a comprehensive revision of the CLP Regulation, with the objective of aligning EU classification and labelling rules with amendments made to the United Nations GHS.

The proposed changes include:

• New classification and hazard communication requirements for chemicals under pressure.
• Revised precautionary statements to improve clarity and usability.
• Greater use of non-animal testing methods for health hazard classification.
• New provisions for in-vitro and ex-vivo data when assessing skin corrosion and irritation.
• Updated classification approaches for metals and metal compounds regarding long-term aquatic hazards.

There are four major points in the adoption process:

• Stakeholders can submit comments until October 16, 2026.
• Planned adoption for Q4 2026.
• Most new requirements would apply 24 months after entry into force.
• Substances and mixtures already placed on the market under existing rules would benefit from a 48-month transition period.

The proposal is yet another significant step towards the development of hazard classification for EU chemicals, which may have implications on classification, labeling, SDS and regulatory compliance strategies.

Source: https://single-market-economy.ec.europa.eu/sectors/chemicals/chemicals-legislation_en

L'articolo August Regulatory Updates 2026 proviene da ChemSafe.

The UK Food Standards Agency (FSA), in collaboration with Food Standards Scotland (FSS), has released four new guidance documents to support companies developing cell-cultivated foods. Published as part of the Cell-Cultivated Products Sandbox Programme, these documents aim to provide greater regulatory clarity to help businesses bring innovative products to market.

Why has the FSA published these new guidance documents?

Which guidance documents have been published?

The FSA has released four complementary guidance documents addressing different stages of product development and regulatory compliance.

The first guidance focuses on food business hygiene requirements, explaining how existing hygiene rules apply to the production of cell-cultivated foods. It clarifies key aspects such as the regulatory status of production facilities, the application of hygiene principles throughout the manufacturing process and the responsibilities of food business operators.

The second document provides supplementary guidance on identity, production and microbiology, outlining the scientific information expected when characterising cell lines, describing manufacturing processes and demonstrating microbiological safety. Its objective is to help companies prepare more comprehensive dossiers that facilitate the regulatory assessment.

The third guidance, Improving your cell-cultivated product application, offers practical recommendations for preparing high-quality Novel Food applications. Drawing on the FSA’s experience with submitted dossiers, it highlights common deficiencies including incomplete product characterisation, insufficient production process descriptions and poorly structured documentation, and explains how these issues can be avoided.

Finally, the guidance on Novel Food taste trials clarifies the conditions under which taste trials of unauthorised novel foods may be conducted for research and development purposes. It explains the responsibilities of businesses, the importance of risk assessments and ethical oversight, and the role of local authorities in ensuring that these activities remain within the scope of legitimate R&D.

What do these publications mean for the food businesses?

For developers, this increased clarity has the potential to reduce avoidable requests for additional information, improve dossier quality and support a more predictable regulatory pathway as the sector continues to evolve.

Whether you are developing a cell-cultivated product or another Novel Food, understanding regulatory expectations early in development is essential for a successful market authorization strategy. Chemsafe supports companies throughout the entire regulatory process, from scientific and regulatory strategy to dossier preparation and interactions with competent authorities. Contact us to discuss how we can support your next innovation.

You can also meet us at EUROTOX 2026 in Vienna, where we will present a scientific poster exploring the regulatory landscape and challenges of cell-cultivated foods.

L'articolo Cell-cultivated foods: New developments in the recent UK FSA guidance proviene da ChemSafe.

What Is Precautionary Allergen Labelling?

Codex Alimentarius is a collection of FAO/WHO food standards and guidelines designed to protect consumers and promote fair international food trade.

Use of PAL applies to pre-packaged foods and provides a risk notification on accidental contamination of foods with a particular allergen. For instance, milk intentionally used in a recipe must be declared as an ingredient. A statement such as “may contain milk” instead addresses a residual cross-contact risk identified through a risk assessment. Sharing a facility or production line is not, by itself, sufficient to justify PAL.

Why was a new Guidance Needed?

“May contain” statements have often been used extensively and inconsistently.
This may unnecessarily restrict food choices for allergic consumers while reducing trust in warnings that appear on many products.

The guidance therefore aims to make PAL more consistent, meaningful and science based.

Application of the Risk-Based Approach

Food business operators must first implement measures to prevent or minimize cross-contact. PAL is restricted to situations in which unintended allergen presence cannot be adequately prevented or controlled. The process starts with a qualitative risk assessment and may be supplemented by a quantitative assessment. Analytical data may support the evaluation, but quantification is not automatically required.

PAL should be used when unintended allergen presence exceeds the relevant action level after appropriate mitigation. Otherwise, it should not be applied if there is less presence of such substances.

Reference Doses and Action Levels

The reference dose (RfD) is the estimated daily oral exposure level for humans which is likely to result in no adverse effects over the lifetime. Reference doses for allergic reactions are expressed in milligrams of total protein from the allergen-containing food for one occasion of consumption.
Codex values are set at 2 mg for peanut, egg, milk and sesame; 5 mg for wheat and fish; and 10 mg for buckwheat, lupin and soy.
For coeliac disease, a special RfD of 4 mg of total gluten is set for the relevant food sources such as wheat, rye and barley. This value is distinct from the 5 mg RfD established for IgE-mediated wheat allergy.

The action level is calculated by dividing the RfD by the amount of food reasonably expected to be consumed on one occasion. The exposure is compared with the RfD, whereas the estimated concentration in the product is compared with the action level.

Codex Guidance application for European Companies

Codex guidelines are voluntary and do not automatically amend EU legislation. In the EU, substances or products listed in Annex II to Regulation (EU) No 1169/2011 must be declared when used in manufacture and still present in the finished food, including relevant processing aids and derived products. Still, this framework provides an important benchmark for reviewing allergen-management procedures, consumption data, analytical strategies and labelling decisions.

Need help?

The new Codex guidance confirms the importance of a science-based approach to allergen risk. This principle is also relevant at an earlier stage of product development, when the allergenic potential of Novel Food, new food ingredient or food additive must be appropriately characterized as part of its safety assessment.

Chemsafe supports companies in the scientific and regulatory assessment of allergenic potential, from the identification of relevant data requirements to the preparation of the supporting documentation for new ingredients applications. Contact us to know more!

L'articolo Precautionary Allergen Labelling: New Codex Guidance proviene da ChemSafe.

These measures, paired with the broader reform proposal COM/2025/1023 and recent positions from Notified Bodies (Team-NB), aim to make the European Union more competitive and prevent the risk of shortages for critical devices on the market.

Below, we analyze the key points of this evolution and what it means for the sector.

What is a “Well-Established Technology device”?

The new reform proposal aims to insert a formal definition directly into Article 2 (point 72) of the MDR. According to the established criteria, a device is classified as WET if:

• It has a simple, common, and stable design.
• It has a long history on the Union market.
• It possesses well-known clinical performance characteristics and represents the “standard of care” with little evolution in indications.
• It has not been associated with safety issues in the past.

What are the main novelties of the new framework?

The heart of the revision is the shift from static lists to a more flexible and dynamic system. While the June 2026 Delegated Acts have already updated the current lists, the COM/2025/1023 proposal will allow the Commission to update the list of WET devices in the future through implementing acts.

A crucial novelty, supported by Team-NB, is the introduction of risk-adaptive surveillance. This approach ensures that surveillance by Notified Bodies is no longer rigidly fixed but is instead proportionate to the risk of the device and the manufacturer’s demonstrated compliance history.

Adaptive Surveillance: How will the role of Notified Bodies change?

According to the Team-NB position paper and the ongoing reform, the system will evolve toward dynamic monitoring that includes:

• Periodic Reviews instead of Recertification: The maximum 5-year validity of certificates would be removed and replaced by periodic reviews proportionate to the risk of the device.
• Surveillance Levels: Manufacturers (or device groups) would be assigned to different levels (initial/enhanced, medium, or reduced) based on vigilance data and post-market performance.
• “For-Cause” Audits: The intensity of controls can be immediately increased (re-escalation) in the event of serious incidents or recurring non-conformities.
• Focus for WET: For established technologies, audits may benefit from reduced times and focus more heavily on post-market surveillance (PMS) technical documentation.

What concrete advantages do these simplifications offer?

For devices classified as WET, manufacturers can benefit from more proportionate requirements, including:

• Exemption from clinical investigations: For listed implantable and Class III devices, clinical evaluation can be based on sufficient clinical data and compliance with Common Specifications (CS).
• Simplified technical documentation assessment: For Class IIb implantable devices considered WET, the Notified Body can perform the assessment on a sampling basis (one representative device per generic device group).
• Reduced vigilance burdens: The frequency for updating Periodic Safety Update Reports (PSUR) is being made more flexible for lower risk classes.

Which devices have been included in the new lists?

Delegated Regulations (EU) 2026/1359 and (EU) 2026/1451 have extended WET status to products such as:

• Sutures, staples, dental fillings, and orthodontic braces.
• Cannulas, catheters, and feeding tubes.
• Bone substitutes, nails, anchors, and reusable surgical instruments.

Why is this reform vital for SMEs?

Small and medium-sized enterprises benefit directly from reduced compliance costs. The proposal includes significant fee reductions (at least 50% for micro-enterprises) for access to expert panels and certification procedures. Furthermore, the EMA will establish a dedicated support office for SMEs to help them navigate MDR requirements.

What to expect for the future?

While the technical exemptions for the new WET lists are already operational, the structural reform (COM/2025/1023) is continuing its legislative path, with adoption expected in the second quarter of 2027.

At Chemsafe, we help companies monitor these regulatory changes and implement surveillance systems that meet the new adaptability criteria. From defining clinical evaluation strategies to supporting the identification of WET devices, we transform regulatory challenges into growth opportunities.
Contact us to let us know about your project.

L'articolo EU MDR Well-Established Technologies (WET): Simplification in EU Medical Device Regulations proviene da ChemSafe.

Scientific progress has greatly improved our understanding of how contaminants behave in the environment, while increasing attention has been given to emerging substances such as PFAS, endocrine-disrupting chemicals and microplastics.

The revised Drinking Water Directive (EU) 2020/2184 (DWD) reflects this evolution.
The Directive introduces a comprehensive risk-based approach covering the entire drinking water supply chain, rather than focusing only on compliance at the consumer’s tap.

The risk based approach starts with the protection of water sources and treatment processes and ends with distribution systems – including products that come into contact with drinking water.

This directive represents a shift from monitoring water quality to preventing contamination at its source, introducing new responsibilities for competent authorities, manufacturers, water suppliers and economic operators throughout Europe.

The two pillars of the new framework

The revised Directive strengthens monitoring requirements by providing for new criteria for several emerging contaminants, including PFAS, beta-estradiol and nonylphenol.

Moreover, there are two complementary provisions, Article 11 and Article 12, which establish a harmonized framework for controlling materials and products that come into contact with drinking water for the first time.

Together, they ensure that drinking water remains safe not only because it is monitored, but also by appropriate assessment of every chemical and material that is in contact with it.

Article 11: Harmonising materials in contact with drinking water

Article 11 applies to materials and products used in the abstraction, treatment, storage and distribution of drinking water, such as pipes, fittings, valves, tanks and other infrastructure components.
Its objective is simple yet ambitious: one standard, one test, one market.

Manufacturers will progressively rely on a harmonised European framework, instead of following different national systems. This will reduce regulatory fragmentation while maintaining a high level of public health standards.

This system, developed with the scientific support of ECHA, is based on four key elements:

• European Positive Lists of authorized starting substances, compositions and constituents;
• Harmonized risk assessment methodologies;
• Common information requirements for new applications;
• Transparent procedures for updating the Positive Lists depending on changes in scientific data.

For manufacturers of drinking water contact materials, this represents an important change. The creation of reliable scientific dossiers using IUCLID will definitely become a crucial step toward compliance and market access within the EU.

EU implementation: Article 11 Deadlines 

In detail the key dates include:

• 12 January 2021
  The revised Drinking Water Directive enters into force, introducing a new risk-based approach to drinking water safety.
• 23 April 2024
  The European Commission publishes the implementing acts defining the European Positive Lists, information requirements, risk assessment methodologies and administrative procedures.
• 5 January 2026
  Economic operators and Member States can begin notifying ECHA of their intention to submit proposals for adding, amending or removing entries from the European Positive Lists.
• 31 December 2026
  Two important milestones are reached:
  • the first European Positive Lists become applicable;
  • companies can begin submitting full applications to ECHA to add, amend or remove entries from the Positive Lists.

• 31 January 2032
  The European Commission will review the implementation of the revised Drinking Water Directive and evaluate whether further improvements are needed.
• 31 December 2032
  The transitional provisions expire for substances that had previously been approved by Member States during the transition period between 13 July 2021 and 31 December 2026.

What’s next for manufacturers?

Although the first European Positive Lists will only become fully operational at the end of 2026, companies should prepare themselves for this deadline.

Manufacturers need to begin evaluating their portfolio to determine whether the substances used in their drinking water contact materials are already included in the European Positive Lists or whether a future application to ECHA may be required.

Where additional data is needed, early planning will be essential to generate the scientific evidence required for an IUCLID submission.
Taking these steps now will help avoid delays once the European system becomes fully operational.

Article 12: Treatment chemicals and filter media

Whereas Article 11 adresses construction material, Article 12 regulates treatment chemicals (reagents) and filter media used during drinking water treatment.
These products play a critical role for usuring and maintaining water quality; however, since they are intentionally added to water or directly interact with it, they require particularly rigorous health-based oversight.

Unlike Article 11, which is largely harmonized at EU level, Article 12 is implemented by the individual Member State.

In Italy, both products are collectively known as ReMaF, and their authorization is regulated through Legislative Decree 18/2023, recently updated by Legislative Decree 102/2025.

The Italian framework involves several public authorities:

• CeNSiA (National Centre for Water Safety), responsible for product authorizations;
• ASL, responsible for inspections and market surveillance;
• USMAF, overseeing imports from non-EU countries.

To support this system, Italy has also developed the AnTeA Platform, which hosts the national ReMaF Database, ensuring product registration, traceability and transparency throughout the market.

Italian implementation: Article 12 Deadlines

Italy has established its national implementation through Legislative Decree 18/2023 and Legislative Decree 102/2025.

The key deadlines are:

• 13 January 2026
  • Opening of the national ReMaF authorization procedure through the AnTeA platform.
  • Beginning of market surveillance by the competent authorities.
  • Application of the new drinking water limits for PFAS, Bisphenol A and chlorate.
• 12 January 2028
  Existing ReMaF products already on the market (excluding products subject to specific sectoral legislation) must have entered the authorization process.
• 13 January 2036
  Only ReMaF products authorised by CeNSiA, registered in the national ReMaF Database and correctly labelled may be placed on the market or used in drinking water systems.
  This is also the deadline for compliance with the stricter limit value for lead (5 μg/L).
• 12 January 2037
  End of the transitional period for products already placed on the market before the mandatory implementation date.

How should companies prepare?

The implementation process in Italy has created a new authorization pathway for producers and distributors of treatment chemicals and filter media.
The companies should start assessing whether their products fall within the scope of the ReMaF framework and plan the activities required for compliance, including certification where applicable, preparation of the technical documentation, CeNSiA authorization and registration in the AnTeA platform.

Considering the long implementation timeline, early preparation will provide an opportunity to spread the workload and avoid regulatory bottlenecks as the mandatory deadlines approach.

Looking ahead

The revised Drinking Water Directive is revolutionizing the regulation of drinking water safety in Europe.
While the process of its implementation will continue over the coming years, the regulatory direction is already clear: greater harmonization at European level, improved scientific assessment and increased accountability for manufacturers placing products on the market.

Companies that start preparation now will be in a better position when the new regulations come into effect.

At Chemsafe, our combined expertise in regulatory affairs, toxicology and European chemicals legislation knowledge help us assist manufacturers in complying with both Article 11 and Article 12.
Our Chemical BU Head, Francesca, has extensive experience in the area of drinking water safety. It was the focus of her PhD research, which she expanded with research activities at the U.S. Environmental Protection Agency (US EPA).

Whether you are preparing an ECHA submission, assessing substances for inclusion in the European Positive Lists or navigating the Italian ReMaF authorization system, our company can help you.
Just contact us to get your compliance strategy ready to use.

L'articolo The EU Drinking Water Directive: Deadlines to Know for Compliance proviene da ChemSafe.

Ethanol CAR Published – Join Our Task Force!

The Competent Authority Report (CAR) for Ethanol has been officially published. In response to this update, we are setting up a dedicated Task Force. If you are interested in participating or would like to collaborate, please contact us directly.

Source: https://echa.europa.eu/documents/10162/3780f812-dddd-2a51-3f40-96b97acbb7fb

Open Consultation on biocidal products: DRAFT Guidance on Substances of Concern (SoC)

A public consultation is currently underway for the draft “Guidance on Substances of Concern (SoC)”. This document describes how to identify a SoC and perform its assessment under the Biocidal Products Regulation (EU) No 528/2012 (BPR).

Source: DRAFT Guidance on the Biocidal Products

ECHA Opinions On Active Substances 

Renewals on:

• Aluminium phosphide releasing phosphine for Product Types (PT) 14, 18, and 20.
• Magnesium phosphide releasing phosphine PT 18.
• Peanut butter, seeds of the groundnut (Arachis hypogaea L.) roasted, peeled and crushed for PT 19.
• Zinc pyrithione for PT 21.

Medical Devices:

FDA official recognition of the ISO 10993-1:2025

The FDA has officially recognized ISO 10993-1:2025 for the biological evaluation of medical devices, marking a major step toward global harmonization in biocompatibility.

Here are the key takeaways for your regulatory strategy:

• Partial Recognitions: Note that the phrase “consumer products or” (Clause 6.5.11.3) and Biological risk estimation (Clause 6.9) are only partially recognized.
• Transition Timeline: The 2018 version is being phased out. The FDA will accept declarations of conformity to ISO 10993-1:2018 until July 1, 2029. After this date, only the 2025 version will be accepted.
• Action Item: Manufacturers should begin gap assessments and plan updates to their biological evaluation processes, testing strategies, and upcoming premarket submissions.

Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=47116

New WET Delegated Regulations Published in the Official Journal of the EU

On June 29, 2026, the two Delegated Regulations expanding the list of Well-Established Technologies (WET) under the Medical Devices Regulation (MDR) were published in the Official Journal of the European Union. The Regulations will enter into force 20 days after publication, introducing new regulatory simplifications for the devices covered, including specific exemptions from clinical investigation requirements and streamlined conformity assessment provisions for eligible technologies.

Source: https://ec.europa.eu/newsroom/sante/items/945829/en

MedTech Europe Outlines Priorities for the IVDR Revision

As the debate around the future of European medical regulations intensifies, MedTech Europe has published a targeted supplement paper titled “An Improved Regulatory Framework: What Do Europe’s Diagnostics Need?”. Released on June 3, 2026, the document outlines critical pillars to safeguard and advance the In Vitro Diagnostics (IVD) sector:

• Risk-Proportional Approach: Supports eliminating the fixed 5-year recertification cycles in favor of reviews based on the actual risk profile.
• Orphan Diagnostics: Proposes aligning the “orphan diagnostic” definition with the EU rare disease threshold (5 in 10,000 people per year) to protect essential testing.
• SME Simplification: Advocates for reduced administrative burdens and more predictable conformity assessment timelines to support small and medium-sized enterprises.
• Digitalization & Innovation: Promotes electronic technical file submissions, e-IFUs, and accelerated market pathways for breakthrough diagnostic innovations.Source:

Source: https://www.medtecheurope.org/wp-content/uploads/2026/06/260526_ivd-specific-paper_final.pdf

Food:

Vitamins/Minerals and Novel Foods: EFSA Rejects Zinc L-Carnosine as a Source of Zinc

On June 17, 2026, EFSA published its opinion on the safety of zinc L-carnosine as a novel food and on the bioavailability of zinc from this source in the context of Directive 2002/46/EC on food supplements.

The assessment highlights concerns regarding characterization, particle/nanoparticle behavior, dissolution, and bioavailability.
EFSA concludes that the novel food is not sufficiently characterized and that neither bioavailability nor safety can be established.

This affects producers and suppliers working on new mineral sources. The use of a new form of zinc in dietary supplements is not merely a “nutritional” issue: it may require a novel food assessment and proof of bioavailability to be approved as a permitted source.
It is crucial to monitor any R&D developments or supplier requests regarding zinc L-carnosine. Do not treat it as a simple alternative form of zinc without regulatory verification. Request a complete dossier from suppliers covering characterization, particles, dissolution, and bioavailability.

Source:https://www.researchgate.net/publication/407308232_Safety_of_zinc_l-carnosine_as_a_novel_food_pursuant_to_Regulation_EU_20152283

June 2026 Authorizations from the European Commission

The Commission adopted two significant implementing regulations in June 2026:

• Implementing Regulation (EU) 2026/1219 of June 9, 2026, authorizing inulin propionate ester as a novel food;
• Implementing Regulation (EU) 2026/1306 of June 11, 2026, authorizing carrot extract enriched with rhamnogalacturonan-I / cRG-I as a novel food.

For cRG-I, the application covered various foods intended for the general population, including food supplements.

Opportunities for R&D and ingredient scouting, but to be handled with caution. Novel food authorization does not equate to unrestricted use: it is necessary to review the Union list entry, authorized categories, maximum levels, specifications, conditions of use, labeling, and any data protection provisions.

Source:https://eur-lex.europa.eu/eli/reg_impl/2026/1306/oj/eng

L'articolo June Regulatory Updates 2026 proviene da ChemSafe.

The Regulation is not only focused on waste management. It reflects a broader regulatory shift towards packaging prevention, recyclability, recycled content, minimization and control of substances of concern. In this context, one key issue for operators is the presence of PFAS in food-contact packaging.

Why are PFAS relevant for packaging compliance?

PFAS, often referred to as “forever chemicals”, are a broad group of substances used across several industrial sectors because of their resistance to water, grease, heat and chemicals. Their use is not limited to packaging and may involve, among others, textiles, cosmetics, industrial applications and manufacturing processes.
In the EU, PFAS are also subject to a broader regulatory discussion under REACH. In March 2023, national authorities submitted a request to ECHA for a restriction of PFAS as a group, moving away from a substance-by-substance approach.

For companies, this means that PFAS compliance should not be treated only as a finished-product issue. The assessment may need to cover raw materials, coatings, additives, processing aids, recycled inputs, supplier documentation and possible contamination along the supply chain.

Will food-contact packaging containing PFAS be banned from 2026?

The PPWR introduces a specific restriction for food-contact packaging.

From 12 August 2026, food-contact packaging shall not be placed on the EU market when containing PFAS at or above specific concentration limits: 25 ppb for any PFAS measured by targeted PFAS analysis, 250 ppb for the sum of targeted PFAS, and 50 ppm for PFAS including polymeric PFAS.

This does not mean that all packaging will be banned in 2026. It means that food-contact packaging will need to be assessed against clear thresholds, and compliance will have to be demonstrated through appropriate technical documentation.
From a practical perspective, the key question is not only whether PFAS have been intentionally added. Operators should also consider whether PFAS may be present due to coatings, surface treatments, inks, adhesives, recycled materials or other inputs used in the production process.

How do REACH and the PPWR overlap?

The REACH PFAS restriction proposal and the PPWR requirement are linked, but they are not the same instrument.

REACH addresses PFAS from a chemical regulation perspective, potentially affecting substances, mixtures and articles across many sectors. The PPWR already introduces a specific requirement for PFAS in food-contact packaging.

This creates an important overlap for companies placing packaging on the EU market. A material may need to be assessed both as an article potentially affected by chemical restrictions under REACH and as packaging intended to come into contact with food under the PPWR and Regulation (EC) No 1935/2004.

This distinction is particularly relevant because a material that appears acceptable from a general chemical compliance perspective may still require a dedicated food-contact assessment. Conversely, a food-contact evaluation that does not consider REACH may underestimate future restrictions affecting substances or manufacturing processes.

What comes after the 2026 PFAS deadline?

Why is an integrated assessment needed?

PFAS in packaging is a multidisciplinary issue at the intersection of chemical regulation and food safety.

At Chemsafe, the Chemical and Food Business Units work together to assess packaging materials from both perspectives. This allows companies to verify not only whether a material is compliant under REACH, but also whether it can be considered safe and compliant as a food-contact material under the PPWR and Regulation (EC) No 1935/2004.

This integrated approach is particularly important in the current transition phase. Companies should not wait for the 2026 deadline to review their packaging portfolio. A structured assessment can help identify critical materials, request meaningful supplier documentation, define analytical strategies and anticipate the additional requirements that will become relevant from 2030.

Packaging compliance is becoming a technical and regulatory strategy that starts from material selection and supply chain control.
Discover more about our updated food services and stay compliant!

L'articolo Packaging Compliance in the PPWR Era: Beyond PFAS proviene da ChemSafe.

The Digital Product Passport (DPP) has been introduced for the first time in Regulation (EU) 2024/1781, known as ESPR, which establishes a framework for setting ecodesign requirements for sustainable products.

What is the Product Digital Passport (DPP)?

• Compliance Verification: It serves as a digital declaration that the product meets all applicable regulatory requirements.
• Accessibility: It provides consumers, authorities, and other stakeholders with immediate and easy access to essential information, such as the full list of ingredients.
• Enhanced Surveillance: It allows market surveillance and customs authorities to perform automatic checks at EU borders, verifying the existence of a valid passport before products are released for free circulation.
• Traceability: It ensures that products can be tracked throughout the supply chain for a period of ten years.

What are the DPP duties to follow?

• Manufacturers: They have the primary responsibility. They must create the DPP for each product model, ensure it is accurate and updated, and upload the unique product and operator identifiers into the central EU registry. By creating the passport, the manufacturer assumes full legal responsibility for the product’s compliance.
• Authorized Representatives: For manufacturers based outside the EU, the representative must verify that the DPP has been created and that the required information has been entered into the registry. They must also keep the DPP available for national authorities for ten years.
• Importers: Before placing a product on the market, importers must ensure that the manufacturer has completed the conformity assessment and created the digital passport. They are also required to keep a reference to the unique product identifier for ten years.
• Distributors: Their role is to verify, with “due care,” that the product is accompanied by the required data carrier (e.g., the QR code) so that the final user can access the passport information.

• Create the digital passport;
• Make sure the data carrier (e.g., QR code) is available on the label or packaging;
• Enter a reference to the passport in the Union Central Register.

Stay always up to date, we publish blog articles weekly!

L'articolo Regulation (EU) 2024/1781: Introduction of the Digital Product Passport proviene da ChemSafe.

As the pharmaceutical industry continues to rely on complex biological and semi-synthetic manufacturing routes, this guidance offers a more structured approach to ensuring product quality, safety, and regulatory compliance.

Why This Guidance Matters

Traditional impurity guidelines, such as ICH Q3A(R), ICH Q3B(R2), and ICH M7(R2), were primarily developed for chemically synthesized drug substances. However, many antibiotics are produced through fermentation or semi-synthetic methods, which generate significantly more complex mixtures of compounds.

Unlike chemically synthesized APIs, fermentation-derived antibiotics often contain:

• Structurally related active analogs;
• Process-related impurities;
• Degradation products formed during manufacturing or storage.

The FDA recognizes that these products require a tailored impurity control strategy that reflects their unique manufacturing processes.

Understanding Antibiotic Impurities

The guidance defines impurities as compounds that differ from the intended drug substance and do not possess biological activity comparable to the active ingredient.

In contrast, antibiotic-related analogs are structurally related variants formed during production that maintain biological activity similar to the active ingredient and are therefore not considered impurities.

This distinction is critical when developing specifications and evaluating product quality.

FDA Recommendations for Specifications

The FDA recommends that manufacturers establish comprehensive specifications for both drug substances and drug products.

Drug Substances specifications should include:

• Identified impurities;
• Unidentified impurities;
• Unspecified impurities;
• Total impurity limits.

Drug Products specifications should include:

• Identified degradation products;
• Unidentified degradation products;
• Unspecified degradation products;
• Total degradation product limits.

The objective is to ensure that every batch consistently meets established standards for identity, strength, quality, and purity.

Establishing Acceptance Criteria

One of the most important aspects of the guidance is determining acceptable limits for impurities and degradation products.

The FDA recommends that acceptance criteria be supported by:

• Clinical data;
• Nonclinical studies;
• Comparative analyses with reference products;
• Scientific literature;
• Prior development knowledge;
• Analytical method capability.

Where impurity levels remain below the qualification thresholds described in ICH Q3A(R2) and ICH Q3B(R2), additional justification is generally not required, provided there are no toxicological concerns.

However, if impurities exceed qualification thresholds or raise potential safety concerns, manufacturers may need to provide additional toxicological data and risk assessments.

Increased Focus on Mutagenic and Carcinogenic Risks

The guidance highlights the importance of evaluating impurities with potential mutagenic or carcinogenic properties.

Manufacturers are encouraged to conduct risk assessments consistent with ICH M7(R2), particularly when structural alerts for mutagenicity are identified. Special attention should be given to nitrosamine impurities and other compounds that may fall within the “cohort of concern” category.

This reflects the broader industry trend toward proactive impurity risk management and patient safety.

Different Pathways for Different Application Types

The FDA provides specific recommendations depending on the regulatory pathway:

1. New Drug Applications (NDAs)

For innovative products, impurity limits may be based on ICH qualification thresholds, supported by toxicological justification when necessary.

2. Abbreviated New Drug Applications (ANDAs)

Generic manufacturers may establish impurity limits using:

• USP monograph requirements;
• Comparative analyses with the Reference Listed Drug (RLD);
• ICH qualification thresholds.

3. OTC Monograph Drugs

For over-the-counter antibiotic products, manufacturers are encouraged to follow USP monographs and compendial standards, while also addressing any identified toxicological concerns.

Pharmaceutical Industry Implications

Although the guidance is currently in draft form, it signals the FDA’s expectations for future antibiotic development and manufacturing programs.

Organizations developing fermentation-derived or semi-synthetic antibiotics should begin evaluating:

• Existing impurity profiles;
• Analytical method capabilities;
• Qualification strategies;
• Risk assessment procedures;
• Alignment with ICH and USP requirements.

Early preparation will help streamline future regulatory submissions and reduce the likelihood of compliance challenges.

Looking Ahead

The draft guideline by the FDA is one way towards harmonizing the impurity control strategies for complex antibiotic products. By providing a clearer framework for impurity identification, qualification, and control, the agency aims to support the development of high-quality antibiotics while ensuring consistent standards across the industry.

Since the issue of antibiotic resistance continues to drive innovation in antibiotic development, the importance of impurity control strategies will remain a critical component of pharmaceutical quality systems and regulatory success.

Stay ahead of regulatory developments, compliance challenges, and pharmaceutical innovations on our related blog category.
Explore our latest insights and discover how Chemsafe supports regulatory excellence.

L'articolo FDA sets Impurities Specifications: New Draft Guidance on Antibiotics proviene da ChemSafe.