The current Regulation has been replaced by Regulation (EU) 2026/405, which was published in the Official Journal and entered into force last March. However, it will not come into effect until September 2029, with Regulation 648/2004 remaining fully in force until that date. With regard to biodegradability alone, this new text significantly modifies the approach adopted to date: it broadens the scope to include new components, refocuses the requirements applicable to surfactants on ultimate aerobic biodegradation, and removes the derogation mechanism based, in particular, on primary biodegradation. These changes, which will be phased in between 2029 and 2034, nevertheless require manufacturers in the sector to start preparing for them now.

Implementation roadmap

• 22 March 2026: entry into force of Regulation (EU) 2026/405 (start of the 42-month transition period).
• 23 September 2029: application of the new Regulation and repeal of Regulation 648/2004.
• 23 March 2032: biodegradability requirements – mandatory compliance for water-soluble polymer films.
• 23 March 2034: biodegradability requirements – mandatory compliance for organic substances intentionally added at ≥ 10 % m/m.
• Products already compliant with Regulation 648/2004 and placed on the market before 23 September 2029 may continue to be marketed indefinitely (Article 36(1)). Those placed on the market between 23 September 2029 and 22 September 2030 may be marketed only until 23 September 2030 (Article 36(2)).

1. A significantly broader scope

Regulation 648/2004 focused its biodegradability requirements solely on surfactants. Regulation 2026/405 introduces, for the first time, targets for two categories of components not previously covered:

• Films and the polymers they contain must meet biodegradability criteria from 23 March 2032.
• Organic substances (other than surfactants or polymer films) that are intentionally added and present in a concentration of at least 10% of the product’s total mass must meet the biodegradability requirements by 23 March 2034.

These substances, other than surfactants, may persist in waste water and accumulate in the environment if they are not removed at wastewater treatment works. The 10% threshold is calculated on the basis of the total mass of the substances, excluding water, in order to ensure equal treatment between liquid and solid products and to avoid any dilution effect.

At an operational level, Article 4 of Regulation 2026/405 sets out this timeframe:

The European Commission is responsible for defining the relevant criteria and test methods using a phased approach, prioritising those components likely to have the most significant environmental impacts.

2. Surfactants: a requirement unchanged, criteria revised

Regulation 2026/405 reaffirms the principle already set out in Regulation 648/2004: surfactants, and detergents containing them, must meet the criteria for ultimate aerobic biodegradation. Surfactants, whilst essential to the effectiveness of detergents, pose an environmental risk when released into sewerage systems or directly into surface waters.

The main change lies in the removal, in the new Regulation, of primary biodegradation as a component of the regulatory framework applicable to surfactants.

a. A definition being phased out

Regulation (EC) No 648/2004 defines, in Article 2(7) and (8), two distinct concepts:

• primary biodegradation: the structural transformation of the surfactant leading to the loss of its surface-active properties;
• ultimate aerobic biodegradation: the substance being completely used by micro-organisms, which break it down into carbon dioxide, water and mineral salts (mineralisation) and into new microbial cellular constituents (biomass).

Regulation 2026/405 no longer includes the definition of primary biodegradation in Article 2, nor does it set any compliance threshold for this parameter (which is 80% under Regulation 648/2004).

b. A single requirement: the mineralisation threshold

From 23 September 2029, all surfactants must directly meet the criterion for ultimate aerobic biodegradation in order to be placed on the market. The criteria remain set at 60% biodegradation within 28 days for methods based, in particular, on oxygen consumption or CO₂ production, and at 70% for methods based on the removal of dissolved organic carbon (DOC).

Two test conditions, which are already included in the current regulation but which are now mandatory in the absence of an alternative approach, deserve particular attention.

• No pre-adaptation of the inoculum: the inoculum, the mixture of microorganisms, often derived from sewage sludge, used to degrade the test substance, must not be exposed to the test substance prior to the start of the test. Tests must be carried out using microbial populations that have not been pre-exposed, in order to verify that the substance is truly degradable under realistic environmental conditions.
• No ‘10-day window’ rule: the test methods to be used (C.4-A to C.4-F) are the same as those employed by the OECD to screen for a substance’s ‘readily biodegradable’ properties. Normally, the substance must pass the threshold within 10 days of reaching 10% degradation; otherwise, it is deemed to have failed, even if it reaches 90% within 28 days. The Detergents Regulation adopts these same methods but explicitly excludes the 10-day window. Consequently, only the final result at 28 days matters, regardless of the rate of degradation.

These test conditions are not new: they are already set out in the current regulation and apply to ultimate biodegradation tests, regardless of the surfactant being tested. What has changed is the consequence of failing this test. Regulation 648/2004 still allows, for surfactants intended for detergents for industrial or institutional use, a derogation conditional upon demonstrating primary biodegradability and a supplementary risk assessment. This option will cease to exist with the removal of the requirement for primary biodegradability.

c. The repeal of the exemption system based on primary biodegradability

Under Regulation 648/2004, primary biodegradability acted as a ‘safety mechanism’: a manufacturer whose surfactant failed the ultimate aerobic biodegradation test could apply for an exemption, provided they demonstrated a level of primary biodegradation of at least 80%.

Regulation 2026/405 removes this systematic exemption route for surfactants. The phased approach is now reserved for the gradual inclusion of new components (films and high-concentration organic substances) within the scope of ultimate aerobic biodegradation, with deadlines set for 2032 and 2034. In the view of the European legislator, primary biodegradability does not provide sufficient environmental protection against persistent metabolites. The mineralisation threshold becomes the sole applicable requirement.

3. A phased approach for new components

For polymer films and high-concentration organic substances, Regulation 2026/405 does not yet set out detailed technical criteria: it delegates this task to the European Commission, in accordance with a specific roadmap.

Article 34(1) of the Regulation also provides that, in its review report due by 23 March 2033 at the latest, the Commission must assess the feasibility of extending the biodegradability criteria to intentionally added organic substances present at concentrations below 10 %, or even of lowering this threshold. This review clause confirms the progressive nature of the text: the current requirements are only a first step, set to be strengthened over time.

4. Requirements for testing laboratories

The Regulation maintains strict requirements regarding the qualification of laboratories carrying out biodegradability tests on surfactants. These laboratories must meet one of the following two conditions:

• comply with the principles of good laboratory practice (GLP), in accordance with Directive 2004/10/EC; or
• be accredited to the international standard ISO/IEC 17025, in accordance with Regulation (EC) No 765/2008.

These requirements ensure the consistency and reliability of test results across the EU, which is essential for effective market surveillance.

Key points

Regulation (EU) 2026/405 marks a turning point in the European approach to the biodegradability of detergents:

• It will apply only from 23 September 2029, with Regulation 648/2004 remaining in force until that date, followed by an extension of the scope beyond surfactants, with deadlines in 2032 (polymer films) and 2034 (organic substances ≥ 10%);
• Requirements restructured around a single criterion: the removal of primary biodegradability, with a single criterion of ultimate aerobic biodegradation for surfactants;
• Abolition of the historical exemption system based on primary biodegradability for surfactants;
• A phased regulatory approach, with technical criteria still to be defined by the Commission by 2029 and 2031, and a review clause opening the door to a future tightening of the 10% threshold.

For detergent manufacturers, their formulators and their suppliers of surfactants or polymers, the challenge is dual: to verify now that the available data on surfactants can demonstrate their compliance with the ultimate biodegradation criteria that will apply from 2029, and to anticipate future requirements concerning films, polymers and other organic substances used in formulations.The deadlines of 2029, 2031, 2032 and 2034 must already be integrated into the regulatory and R&D roadmaps of the companies involved.

Do you have any questions about the compliance of your surfactants, polymers or detergent formulations? Equitox can assist you in evaluating the available data, identifying any testing requirements and preparing for these new regulatory requirements.

Please do not hesitate to contact us at the following address: contact@equitox.eu.

Indeed, the container and content must not interact in a harmful way. The packaging must protect the product from external factors (light, moisture, oxygen, etc.) and maintain its stability, while contributing to its identity in certain markets.

Their evaluation is therefore crucial in order to:

• Ensure consumer or patient safety
• Prevent the migration of hazardous substances
• Ensure product stability and compliance with regulatory standards

The major risk lies in the migration of hazardous substances from the container in quantities sufficient to compromise the safety of the product or alter its organoleptic properties (taste, smell, color).Various European markets are concerned by this assessment: The main regulated markets that EQUITOX targets for the assessment of these interactions are as follows:

Food Sector

Materials that come into contact with foodstuffs are governed by Regulation (EC) No. 1935/2004, as well as Regulation (EU) No. 10/2011 specifically for plastic materials and articles intended to come into contact with foodstuffs. These texts set specific (SML) or generic (GML) migration limits to ensure consumer safety.

Cosmetics sector

The requirements of Regulation (EC) No. 1223/2009 on the safety of cosmetic products impose strict criteria for assessing interactions between packaging and formulas. This includes preventing the migration of hazardous substances and ensuring that the final product remains compliant with safety standards.

Medical Devices (MD)

Medical devices are governed by Regulation (EU) 2017/745 and ISO standards. Among these, ISO 10993-18 defines the requirements for the chemical analysis of extractable and leachable substances that may migrate from device materials to the patient or user. ISO 10993-1 provides a framework for the overall biological evaluation of devices. This approach ensures that potential interactions between the device and the packaging do not pose any unacceptable health risks throughout the product’s life cycle.

Analytical and methodological challenges

The impact of container-content interactions on the safety of various regulated products requires the use of robust and relevant analytical methods. It is essential to be able to identify and quantify substances that may migrate from packaging materials into products. However, the composition of packaging materials not always well known, and there is a risk of unintentionally added substances (NIAS) being present, which makes chemical analysis all the more crucial. In particular, these analyses must:

• Be carried out under the right extraction conditions,
• Use suitable solvents and reference substitutes,
• Apply validated analytical methods that guarantee optimal sensitivity, accuracy, and stability (e.g., GC-MS, LC-MS/MS, ICP-MS, etc.).

The crucial role of modeling

When analytical solutions reach their limits, modeling can play a role in predicting which substances are likely to migrate and estimating the extent of this migration/leaching. To do this, modeling tools must take into account the nature and specific characteristics of packaging materials (containers). They must also consider the chemical, physical, mechanical, and usage properties of the products (contents). Finally, robust databases will ensure the reliability of the tool and will require regular updates to guarantee relevant predictions.

New challenges related to recycled materials

Recent regulations such as the Green Deal, the AGEC law, and the 3R decree (reduce, reuse, recycle) introduce additional requirements for recycled materials. These developments add considerable complexity to the assessment of container-content interactions, particularly in the interpretation of test results and the implementation of appropriate methodologies.

Our support services for the assessment of container-content interactions

At EQUITOX, we leverage our expertise in the assessment of container-content interactions to support our clients across all regulated markets: medical devices, cosmetics, food, and more broadly any sector subject to strict product safety requirements

Feel free to contact us for more information: contact@equitox.eu

#EURegulations #Container-content Interactions #REACh #Cosmetics #Materials #Packaging #Compliance #DM #FoodContact

Regulation (EU) 2024/1328 of 16 May 2024 amends Annex XVII of the REACH Regulation by introducing significant restrictions on the use of octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6) due to their very persistent and very bioaccumulative (vPvB) properties, and in some cases, persistent, bioaccumulative, and toxic (PBT) properties. These restrictions have specific implications for several sectors, including medical devices, cosmetics, and pharmaceuticals.

This regulation will apply as of 6 June 2026 with general prohibitions for substances D4, D5, and D6, which can no longer be placed on the market:

• As isolated substances.
• As constituents of other substances.
• In mixtures at concentrations equal to or greater than 0.1% by weight.

EQUITOX has identified the key elements of these restrictions for medical devices. For this sector, the regulation provides for extended transitional periods and specific exemptions:

1. Extended transitional period until 6 June 2031

For medical devices (as defined in Regulation (EU) 2017/745) and in vitro diagnostic medical devices (as defined in Regulation (EU) 2017/746), the deadline is extended to 6 June 2031. This delay is justified by the need to identify substitute substances, carry out qualification tests to validate the safety and performance of alternatives, and complete the necessary regulatory updates (certifications, CE marking).

2. Specific exemptions

Certain uses in medical devices are exempt from the restrictions under specific conditions:

• Devices for scars, wounds, and stomas: Substances D5 and D6 can continue to be used without specific concentration limits for devices intended for scar treatment and care, wound prevention, and stoma care.
• Dental impression devices: Mixtures containing ≤ 0.3% D5 or ≤ 1% D6 can be used for dental impressions.
• Other medical devices (not mentioned above): Tolerated concentrations are ≤ 0.2% for D4, D5, or D6 for applications other than dental.

3. Limit values for mixtures containing residual D4, D5, and D6

For certain devices where silicone residues are present, limit values are set to ensure regulated use:

The implications for medical device manufacturers require immediate actions to identify whether D4, D5, or D6 substances are present in their products or processes. If so, their concentrations must be quantified to ensure compliance with the defined thresholds. These actions will enable planning for compliant alternatives by 2031 to avoid any regulatory disruption.

These restrictions may have direct consequences on certification processes. Any formulation change will require an update of the technical documentation and CE certifications (according to Regulation (EU) 2017/745).

Regulation (EU) 2024/1328 encourages stakeholders to seize opportunities for innovation by investing in the development of environmentally friendly alternatives and positioning compliant products as a competitive advantage.

The new restriction on substances D4, D5, and D6 can be seen as a step forward in limiting the environmental impact of chemical products. However, it imposes significant challenges on medical device manufacturers, particularly in terms of reformulation, qualification, and certification. The transitional periods and exemptions provide time to adapt, but it is essential to start preparing now to ensure long-term compliance.

EQUITOX experts are here to support you in ensuring compliance and turning these constraints into opportunities: contact@equitox.eu

Advanced materials (AdMat) are materials designed to offer superior properties to conventional materials. They are defined by their performance and functionality and are distinguished by:

• Their specific composition (complex alloys, hybrid composites, smart polymers, nanostructures, etc.)
• Their controlled microstructure (grain size, crystal orientation, multi-scale organization)
• Their unique functionalities (conductivity, mechanical strength, shape memory, self-repair, response to external stimuli, etc.).

Nanomaterials are defined by their size (less than 100 nm in at least one dimension) and their properties emerge from surface effects. Nanomaterials therefore constitute a specific subcategory of AdMats.

A strategic class of materials

Smart coatings, nanocarriers, bio-based polymers, and metamaterials: these advanced materials are driving innovation in the energy, mobility, construction, healthcare, electronics, and many other sectors.

Demand for AdMat is expected to grow significantly in the coming years, and these materials are set to play a key transformative role in the European Union’s (EU) ecological and digital transitions.

However, as science progresses and their complexity increases, regulatory challenges are multiplying.

What about regulation?

Concerns about the bioavailability and toxicity of nanomaterials have led to the introduction of dedicated regulations (e.g., REACh) over many years.

Although the term “advanced materials” is increasingly used in political circles and in EU research and innovation (R&I) groups, it does not have a harmonized definition in EU legislation.

The OECD, ISO, and national authorities such as the BfR and BAuA in Germany have each proposed nuanced working definitions, converging around materials rationally designed to exhibit new or enhanced properties and functionalities. However, their diversity in terms of structure, function, and composition makes them difficult to regulate under a single framework. This heterogeneity also complicates a harmonized approach to risk assessment.

However, since 2006, the OECD Working Party on Manufactured Nanomaterials (WPMN), initially dedicated to manufactured nanomaterials, has broadened its scope to include advanced materials and their potential risks to human health and the environment.

For chemical manufacturers, formulators, and technology providers, this lack of regulatory clarity creates a grey area:

• Are their materials subject to specific rules for nanomaterials?
• What data is needed to demonstrate their safety and sustainability?
• How can they position their innovation while remaining compliant?

Ultimately, this ambiguity creates uncertainty regarding market access, product classification, and risk communication, which can slow down time to market and complicate dialogue with customers.

European coordination

European regulators are taking action to remedy this situation, especially since AdMats are among the ten critical technology areas for the economic security of the European Union.

The OECD, the European Commission, and consortia such as the Malta Initiative[1] are therefore actively working to define, prioritize, and create testing methods and governance strategies tailored to AdMats.

At the same time, the EU’s chemical strategy for sustainability and Safe-and-Sustainable-by-Design (SSbD[2]) policies are driving the search for materials that are not only innovative, but also safe and sustainable, from the laboratory to the market.

Materials covered, but not explicitly

Many AdMats fall within the scope of existing EU legislation on chemicals (e.g., nanomaterials): REACH, CLP, Biocidal Products Regulation, or Cosmetics Regulation, among others. However, these frameworks do not generally deal explicitly with advanced materials and do not include provisions specific to AdMats, leading to uncertainty and potential gaps in their safety management. Only nanomaterials receive specific attention, for example through updates to the REACH annexes.

Furthermore, the assessment of AdMats faces real operational challenges, such as data requirements and testing protocols that are not adapted to these complex or multifunctional materials. The consequence is, once again, potential gaps in registration, authorization, or defense dossiers.

A common European approach to AdMat governance is both a regulatory necessity to ensure safety and a strategic imperative to promote innovation within the EU. This approach must strike a balance between innovation, safety, and sustainability.

EquiTox closely monitors regulatory developments and changes in testing methodologies for chemicals, including advanced materials.

EQUITOX, your regulatory partner

Feel free to contact us for more information: contact@equitox.eu

#EURegulations #AdvancedMaterials #REACh #ChemicalStrategy #SafeAndSustainableByDesign #ChemicalIndustry #Compliance #Nanomaterials

[1] https://malta-initiative.org/what/

[2] https://research-and-innovation.ec.europa.eu/research-area/industrial-research-and-innovation/chemicals-and-advanced-materials/safe-and-sustainable-design_en

The ERA applies to active substances, and to their metabolites and environmental transformation products where these contribute to exposure or hazard. Excipients fall outside the scope of the guideline.

The life-cycle stage covered begins after administration to the patient, following the down-the-drain pathway (excretion → sewer → sewage treatment plant), then the receiving environmental compartments: surface waters with possible transfer to sediments, soils via sludge application, and into biota through bioaccumulation/biomagnification.

Two assessment phases

Phase I is a screening step based on calculating a PEC (Predicted Environmental Concentration) for surface water. This PEC is compared with the 0.01 μg/L threshold to decide whether to proceed to Phase II. Note that for certain substance classes (endocrine-active substances, antibacterials, antiparasitics) Phase II is required regardless of the PEC.

Phase II offers opportunities to refine the ecotoxicological profile of the substance. It relies on generating and assessing data on (i) environmental fate and behaviour; (ii) chronic ecotoxicity to reduce uncertainty in PNEC (Predicted No-Effect Concentration) derivation for relevant compartments; and (iii) release estimates resulting from patient use. Risk is characterised for each relevant compartment via a Risk Quotient (RQ = PEC / PNEC):

• If RQ < 1, the risk is acceptable.
• If RQ ≥ 1, the risk is not controlled; further refinements and/or risk-management measures are required to ensure RQ < 1 across all relevant compartments.

In parallel, EMA (2024) details the assessment of PBT/vPvB potential, aligned with REACH methodology and criteria.

Beyond the technicalities, the revision shows how EU chemicals regulations interact. By integrating ECHA tools and methods, the EMA strengthens coherence, reduces methodological uncertainty, and avoids unnecessary, costly duplication. It also turns marketing authorisation holders (MAHs) into producers of robust, shareable data (studies, modelling, PBT assessments) that can be useful under other regulatory frameworks such as REACH.

The EMA 2024 revision sits within a broader wave of regulatory reform in Europe. As highlighted by Harrison et al. (July 2025, Environmental Sciences Europe)^[2], forthcoming pharmaceutical regulation is expected to go further: potential refusal of a marketing authorisation on environmental grounds, obligations to assess legacy medicines, and greater transparency via open data. The signal is clear: the environment is becoming a central and durable criterion in medicines regulation.

A clear roadmap for industry:

• Anticipate in R&D signals of persistence, bioaccumulation and modes of action with concern;
• document Phase I and, where needed, build a robust, targeted Phase II;
• convert conclusions into communicable risk-management measures; and,
• reassess when use changes.

The required skill set mirrors this convergence: ecotoxicology, environmental chemistry and fate/kinetics, exposure modelling, and PBT/vPvB expertise.

EQUITOX can support you with the ERA for human medicines under the EMA’s 2024 guideline.

More information: contact@equitox.eu

The reason: a failure in surface treatment.

The usual, well-established surface treatment process could not be applied because of the unavailability of Chromium Trioxide (CrO₃), a key substance in the treatment process that has been subject to REACh authorisation since 2013(2). This issue arose from a lack of regulatory anticipation.

The Weight of Regulation in Industrial Decision-Making

Chromium Trioxide has been listed in Annex XIV of REACh for over a decade, meaning its use requires prior authorisation.

We won’t revisit the fundamentals of the REACh authorisation process or the central role of Annex XIV in managing substances of very high concern. It is now widely acknowledged that understanding and anticipating these regulatory requirements is essential for all actors in the value chain – from manufacturers and importers to formulators and applicators.
This case once again highlights that regulatory anticipation, impact assessment (technical and commercial), and consideration of long administrative timelines are not optional but key levers to protect industrial continuity and corporate reputation.

The Resilience of REACh: From Authorisation to Restriction

The Chromium (VI) authorisation case pushes the REACh framework to its limits, testing its adaptability and flexibility.
According to Article 60 of REACh, the duration of an authorisation is determined on a case-by-case basis, generally between 4 and 12 years. “Case-by-case” means that each application, for each legal entity, must be assessed on its own technical merits (alternatives, substitution, socio-economic analysis, human health and environmental risks). But how can hundreds of dossiers submitted since 2015 be managed efficiently?

The European Commission, via ECHA, is now shifting towards a restriction process: a generic ban with potential derogations. We discussed this evolution back in January(3).

Ongoing discussions are shaping the contours of this future restriction, reaffirming the core principles of REACh: protection of human health and the environment(4). The main direction is clear: a general ban on the use of Chromium (VI) compounds, unless strict conditions are met.
Practically, companies along the entire supply chain would only be allowed to continue using these substances if they can demonstrate strict control of occupational exposure and emissions below defined thresholds. The proper application of these regulatory requirements would then rely heavily on cooperation between industry and local authorities.

According to the current timeline, comments on the restriction report are being collected until mid-December 2025, and the RAC is expected to start reviewing the dossier during its September meeting.

This upcoming regulatory shift aims to simplify processes while requiring industry to tightly control exposures and emissions. A major question remains: how can consistent enforcement be ensured across different local contexts with varying resources and commitment?

Our Expertise
At EQUITOX, we support our clients in analysing REACh compliance, preparing authorisation dossiers, and adapting to new restriction requirements.
This case illustrates how technical, regulatory, and strategic challenges are now deeply interconnected.

Contact us to anticipate and prepare for future regulatory developments.

References:

(1) https://traitementsetmateriaux.fr/des-medailles-en-peau-de-croco
(2) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32013R0348&qid=1644848496011
(3) https://www.linkedin.com/posts/equitox_voici-le-caracal-un-f%C3%A9lin-m%C3%A9connu-aux-nombreux-activity-7286053653700857856-5r2w?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAiDPusB5WZNJoiUQLafrHI2e8LTz8F9ywE
(4) https://echa.europa.eu/registry-of-restriction-intentions/-/dislist/details/0b0236e18971243a

At a time when the European Commission has just published its guidance on the restriction of microplastics (Regulation (EU) 2023/2055), the polymers used in EU fertilising products are also attracting the attention of legislators.

With the publication of Delegated Regulation (EU) 2024/2770 on 28 October 2024, new biodegradability requirements for non-nutrient polymers (coating agents, water retainers, wetting agents) will be introduced into Regulation (EU) 2019/1009 (FPR).

• Why new biodegradability obligations?

When the FPR was adopted in 2019, biodegradability criteria had not been defined, due to the lack of harmonised evaluation methodologies and sufficient environmental impact studies. However, the European Commission has continued its work to regulate the use of non-nutrient polymers, particularly to:

• Address concerns about the accumulation of plastics in terrestrial and aquatic environments.
• Align with the European Strategy on Plastics and the restriction of microplastics established by Regulation (EU) 2023/2055 of 28/09/2023 amending Annex XVII of REACH.

• What does Regulation (EU) 2024/2770 stipulate?

From 17 October 2028, any non-nutrient polymer used in an EU fertilising product must:

Be either a naturally occurring, chemically unmodified polymer or demonstrate its biodegradability according to specific criteria in:

• Soil: 90% degradation or mineralisation within 48 months + the product’s functionality period[1]; and
• Aquatic environments: varying requirements depending on the environment (freshwater, estuarine, marine).

Be tested according to precise standards:

• EN ISO 17556:2019 or ASTM D5988-96:2018 for soil.
• EN ISO 14851:2019, EN ISO 14852:2021 or ASTM D6691:2018 for water.

Note: These changes are not yet included in the consolidated version of the FPR (November 2024), but the Delegated Regulation is already in force.

• Why anticipate these requirements today?

The compliance of existing fertilisers and the development of new products will require rigorous biodegradability testing, along with ecotoxicology assessments and environmental fate evaluations.

For fertiliser manufacturers and raw material producers, integrating these requirements into product development now is crucial to ensure the long-term viability of product ranges beyond 2028.

Do you have questions about the compliance of your polymers or new fertiliser formulations? Our Equitox team is here to assist you!

Feel free to contact us at: contact@equitox.eu.

[1] The time period following use during which the nutrient release is being controlled or the water retention capacity is being increased.

One year later, ISO 10993-1 is being revised, redefining the requirements and general principles for the assessment of biological safety as part of a risk management process (ISO/DIS 10993-1:2024).

The standard is reorganised to emphasise the integration of biosafety assessment into the overall risk management process (ISO 14971). Overall, the document is more precise and will provide more detailed guidance. Here-below are some of the things that will change.

Biological evaluation becomes biocompatibility evaluation, and misuse of the medical device will now have to be taken into account in biological risk assessment.

The Biological Assessment Plan will be documented and the Life Cycle of the medical device will be emphasised to take into account the entire life cycle of the device.

Annex A will evolve towards 4 contact categories and will provide details for calculating the duration of exposure. These changes will make it possible to better characterise the biological risks to be considered for each MD.

Animal protection is more clearly taken into account, with the need to comply with the 3Rs principles – ‘Refine – Reduce – Replace’ – and the use of in vitro/in silico models as a first instance when they are relevant and applicable.

Adjustments will be made to the terminology used, particularly with regard to biological effects and tissue contact.

The annexes will be completely revised, allowing for a more pragmatic approach to risk assessment according to the requirements of EU Regulation 745/2017 (Annex ZA).

This draft revision will lead to greater precision by taking into account the constituents and tissue-device interactions in order to ensure performance throughout the life cycle, as required by EU Regulation 745/2017. The need to use qualified, competent and experienced professionals is emphasised.

It is important to point out that this draft revision will not impose new tests for medical devices already on the market and with established safety profiles. Nevertheless, it will be necessary to re-evaluate historical data to determine the impact of this revision on the pre-existing assessment of the biological safety of the device.

Once the standard has been definitively revised, it also remains to be seen to what extent it will be recognised by the FDA.

If you are a medical device manufacturer wondering about the impact of this new standard on your CE markings, our team of experts will be happy to answer all your questions and help you update your dossiers.

Contact us at the following address: contact@equitox.eu.

Prior to CLP, Member States had set up their own poison notification systems. In accordance with CLP, all declarations prior to Annex VIII are considered valid until 1 January 2025. On that date, only poison centre notifications made using the harmonised format (PCN) will be compliant. If this is not done, the related mixtures may no longer be placed on the European market.

A key point is that product labels will have to include the unique alphanumeric identification code known as the UFI (Unique Formula Identifier).

You are a manufacturer, importer, downstream user and/or distributor of chemical products. Are you wondering about your obligations? You would like to make an assessment of your mixtures’ declarations? You need help with your poison centre notifications (PCN)? You want to anticipate the end of the transitional period and bring your mixtures into compliance? Equitox is here to help!

Don’t hesitate to contact us at contact@equitox.eu.

In the documents presented  [1][2], and following previous discussions among the CAs, the European Commission indicated its desire to strengthen the existing link between the reference product and the SAME product, and to clarify the renewal process for SAME biocidal products.

One of the major points concerns the reaffirmation of the concept of similarity between the reference product and the SAME product. A SAME product must remain identical to its reference product throughout its entire period of use, except for the information specified in Article 22(2)(a), (b), (d), (f), and (g) of the BPR Regulation (EU/528/2012), namely:

• The trade name of the biocidal product;
• The name and address of the authorization holder;
• The authorization number of the biocidal product and, in the case of a biocidal product family, the suffixes to be applied to individual biocidal products belonging to the biocidal product family;
• The manufacturers of the biocidal product;
• The manufacturers of the active substances.

While up until now, SAME product authorizations could be subject to minor and/or major changes independently of the reference product authorization, this will no longer be possible. Their renewal cannot be carried out under a “SAME product” type procedure.

Furthermore, any minor/major change to the reference product must be reflected in the SAME products. If not, it would result in the cancellation of the SAME product authorization. Cancellation could also occur if the reference product is no longer authorized. Thus, the link between the holder of the reference product rights and those exploiting SAME products would no longer be limited to acquiring a letter of access. It would then be necessary to maintain regular relations between the two parties over the long term, at the risk of having a non-compliant SAME product and therefore facing the cancellation of its authorization. Long-term commercial relationships also imply much more complex and financially demanding contractual arrangements.

Thus, the sustainability of these products, their uses, and even the SAME process as a whole may soon come into question.

Comments from Member States are expected during future discussions within the Standing Committee on Biocidal Products.

If you are affected by this issue and have questions or wish to continue the discussion, please do not hesitate to contact us by email at the following address: contact@equitox.eu.

#Biocides #SAME #BPR #Biocial Product Authorisation

[1] https://circabc.europa.eu/sd/a/520bbabb-1325-4c1e-b1b3-1a6d382d24e0/CA-June24-Doc.4.3.a%20-%20SBP%20Regulation(1).docx

[2] https://circabc.europa.eu/sd/a/796c0d43-64f3-4254-9b0e-98a2ad36da68/CA-June24-Doc.4.3.b%20-%20SBP%20Regulation.pptx