Our Services

Do not waste “waste” when it can be a resource for your business!

As a result of the European Green Deal, recycling and recovery of materials from waste is an important, ever-growing domain for manufacturers, importers and downstream users of chemicals alike.

The Waste Framework Directive and its interaction with other legislation (e.g. REACH) is critical to taking informed decisions on regulatory compliance approaches for the recovery and recycling of waste substances.

Apeiron has extensive experience in the recycling industry and can support recyclers and importers of recycled material with ensuring compliance with regulatory requirements.

Apeiron provides support at each stage of waste handling, from waste generation to product recovery (e.g. End-of-Waste status – self-assessments or applications) and beyond, to ensure your compliance strategy is the correct choice for your business.

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For more details on how we can support your business.

Hiram Moerman
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Are you a manufacturer or importer of a recycled/recovered substance from waste? Prove it!

For a recovered material to no longer be considered waste, it must be shown to have reached End-of-Waste status.

The Waste Framework Directive specifies EU-wide product specific criteria, however, the majority of recovered products handled within the EU are not covered at EU-level. Instead, the product must be proven to have reached End-of-Waste status at national or regional level.

The exact End-of-Waste determination procedure differs between EU member states and regions, as well as the reporting obligations and criteria that the recovered substance must satisfy. Take a peek below at our regional-specific guide to End-of-Waste determination!



Unsure on the End-of-Waste determination procedure in your relevant region? Need an assessment (or a second opinion) that your recovered substance is, indeed, no longer waste? Or require support in fulfilling your End-of-Waste reporting obligations? Apeiron can help.

Apeiron has extensive experience in supporting End-of-Waste assessments and applications throughout the majority of EU, including in regions beyond those presented in the guide above.

Move away from toxic substances, search for the better alternative.

The EU commission “Green Deal” program includes an ambition to achieve a toxic free environment. It can only be achieved by gradually substituting toxic substances with less toxic substances. However, toxicity is a concept with different aspects and comparing the toxicity of substances can be complex.

On the other hand when risk rather than hazard is the focus, the toxicity needs to be translated into risk throughout a life cycle of a substance. This requires experienced risk assessors who are familiar with such assessments.

For this purpose, Apeiron-Team proposes a structured approach for alternative assessment. This assessment goes beyond comparing the hazard of the substance but also takes into account the exposure in the life cycle, the technical feasibility and other criteria. By doing so, real alternatives can be distinguished from regrettable substitutions.

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To discuss opportunities on assessing alternatives for your current use of chemical substances.

Hiram Moerman
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Are you placing an article on the EU market that contains SVHCs? Get your SCIP notification in place!

This obligation results from the 2018 update of the Waste Frame Directive and aims at identifying all articles placed on the Eu market which contain substances present on the candidate list in a concentration above 0,1%. This obligation comes into force as of January 5th 2021. The publicly available SCIP database ensures that the information on articles containing Candidate List Substances is available throughout the whole lifecycle of products and materials, including at the waste stage.

Implementing a SCIP database is far and foremost an IT effort. Apeiron-Team can direct your IT team towards the best practices.

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To help you understanding and complying with your SCIP obligations.

Mike Crawford
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How can you benefit from Circular Economy? Are you able to identify and quantify the opportunities the Circular Economy offers for your business? What are the regulatory barriers for more circular activity? What are the policy instruments that you could use to boost the Circular Economy in your company?

Starting from our knowledge of the chemicals legislations and our experience in the recycling and process industry, Apeiron is well placed to support companies in their goal to implement circular business flows. We provide strategic, and practical support for topic.

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To help you setting up your circular business strategy.

Elke Van Asbroeck
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REACH is a challenging regulation! We can be your binoculars to see the future better of your chemical substances and we can help you assess the sustainability of your chemicals portfolio and make it future proof.

RMO

A Risk Management Option analysis (RMOa) allows us to compare several possible scenarios for the future of your chemicals starting from the real concerns in the use of the substance. The different options the regulator and the user of the substance have to manage the risk of using the substance are compared. Missing data to assess the different options is identified. Companies can get prepared when authorities evaluate their options to regulate the future of your substances.

ALTERNATIVE ASSESSMENT

An alternative assessment allows you to evaluate the possibility to substitute a substance of concern with a safer alternative. Our approach for alternative assessment not only takes into account the relative hazards of the substance but also the difference in risk during the lifecycle. The technical and economic feasibility or non-feasibility of alternatives are brought into evidence to be used for strategy development and advocacy.

COMPANIES ARE RESPONSIBLE FOR:

• Which chemicals they use or put on the market,
• How they use the chemicals,
• Knowing and complying with regulatory constraints,
• Looking for safer alternatives.

We have the tools, the skills and the expertise to support you!

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Apeiron-Team offers all the required knowledge, creativity and experience to assist your company through the development of a chemicals strategy.

Elke Vanasbroeck
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It requires scientific, regulatory and industrial expertise to manage compliance with chemicals regulations in an efficient and sustainable way. Failing in either of the three areas of expertise will at best result in suboptimal solutions or at worst in non-compliance.

OUR SERVICES COVER ALL LETTERS OF REACH

Apeiron-Team stays on top of the evolving science and the changing regulations to provide the best possible service for registration of substances for REACH, the maintenance of existing registration dossiers and the support during the REACH evaluation process. We don’t do this for only organic and inorganic substances but also for nano materials and polymers. The latter, although at present without registration obligation, are very much under scrutiny.

We also provide services to manage SIEF obligations. We provide transparent costs calculation for the registration dossiers and manage the communication between registrants. Our understanding of the regulations allows us to support you effectively and efficiently in the implementation of your obligations.

Our experience and knowledge of various industrial processes allows us to engage fast and efficient in case of Authorisation dossiers. We guide and coach the applicant through this process, obtaining robust applications which are seen also by ECHA as best in class.

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To see how we can help to obtain compliance with the chemical regulations.

Hiram Moerman
Contact Our Expert.

Stay on top of your REACH compliance at all times by mapping the chemicals you use. We have the right tool for you!

PORTFOLIO MANAGEMENT

Portfolio management is an essential but very simple and effective tool to manage, document and control the regulatory status of all the substances you use, manufacture or import.
It allows companies to set clear actions and track them easily to meet their regulatory timelines. The impact of upcoming changes in the regulations can be tracked and the impact of these for a portfolio of substances can be estimated.

Priorities are set and budgets can be made accordingly to current and future regulatory obligations and scheduled activities of the regulator such as ECHA’s Chemical Universe.

This results in a Compliance dashboard and a dossier update plan, representing the status of all registrations in a transparent and consistent way. In this manner, our portfolio management allows you to outsource your REACH obligations for your substances without losing oversight!

The Only Representative concept enables a level playing field for non-EU manufacturers

Through appointment of an EU Only Representative (OR), manufacturers located outside of the European Economic Area (EEA) can assume the REACH registration obligations, the same as their EU-based manufacturer counterparts. In doing so, they alleviate their EU customers of needing to REACH register imported chemicals.

THE ONLY REPRESENTATIVE

Apeiron-Team offers Only Representative services and supports non-EEA manufacturers in their REACH related obligations. Aside from the compliance steps, we provide strategic management of the substances for both current and future REACH obligations. We act as the EU-connected eyes of the non-EU manufacturer, keeping watch over the substance and pro-actively notifying of additional obligations or evolutions in the regulatory context.

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To discuss your further needs for setting up an OR ship in the EU!

Mike Crawford
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Contact our expert to discus your further needs for setting up a consortium for the application for authorisation under REACH.

Hiram Moerman
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Make sure that your registration dossier is of high quality and in line with the most recent requirements. Partner up with Apeiron-Team for the development of your registration dossiers, be it lead registration or co-registration dossiers.

NO DATA NO MARKET

REACH requires companies manufacturing or importing substances above 1 tonne per year to complete a registration dossier and submit this to ECHA. In such registration dossier, companies collect information on the substance itself, its hazard properties, its uses and related potential exposure. The potential risks of the use of the substance have to be evaluated and communication on how these risks should be controlled is required.

APEIRON-TEAM HAS ALL KNOWLEDGE

in house to support you in all steps of the dossier generation for both co-registrants and lead registrants. For lead registration dossiers specifically, Apeiron-Team can support you in all the required steps! From literature search and data gap generation, to study monitoring, to compiling the IUCLID dossier to generation of the Chemical Safety Report (CSR). Besides to scientific support, we also offer Letter of Access management, SIEF management, Consortium representation services.

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For support on REACH registrations.

Tine Vandenbrouck
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Apeiron-Team is your partner for the development of an authorisation strategy and for the application for authorisation.

The authorisation process aims to ensure that the risks of substances of very high concern (SVHC) are properly controlled throughout the life cycle. It strives to progressively replace such substances with less hazardous substances or technologies where technically and economically feasible. Substances listed on Annex XIV of the REACH regulation may only be used beyond the sunset date when covered by an authorisation, unless the use is outside the scope of authorisation (e.g. SR&D, intermediates).

JOINED KNOWLEDGE AND EXPERIENCE

An authorisation project starts with defining the authorisation strategy (number of uses, exemptions, the grouping of similar substances, group application). The preparation of an authorisation application is a joint effort with close collaboration between the applicant and Apeiron-Team.

AN AUTHORISATION DOSSIER CONSISTS OF 3 MAIN PARTS:

• A Chemical Safety Report (CSR) demonstrating the risk from using the substance is adequately controlled,
• An Analysis of Alternatives (AoA) assessing potential alternatives and possibly with a substitution plan,
• A Socio-Economic Analysis (SEA) demonstrating the socio-economic benefits outweigh the risk

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Our strength is that we have the in-house expertise to tackle all parts of the dossier. Consistency between the different parts of the dossier can be ensured, a key success factor in applications for authorisation.

Elke Van Asbroeck
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Always be one step ahead… Substances are under scrutiny by the authorities. Make sure that your dossier is complete and anticipate further requests by authorities. Apeiron-Team can help you to be proactive in this process, to get time on your side and to come to the most cost-effective solution in the long run.

Via evaluation processes, ECHA and National authorities aim to ensure that there is sufficient information available on the chemicals placed on the EU market to assess correctly the hazard of the substance. It is up to the industry to meet these extra legal requirements but also to provide input how to meet these requirements. Missing the opportunity to participate in the Evaluation process can lead to significant additional testing costs and in the long run additional regulatory constraints.

APEIRON-TEAM CAN HELP YOU ON DIFFERENT FRONTS:

• Proactive approach: careful evaluation of registration dossiers can indicate possible weaknesses in the hazard assessment
• Reactive approach: by actively participating during the evaluation phase with meaningful imputes.
• Implementation: define and implement thoughtful testing plan

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To be always one step ahead and to make sure that your dossier is complete for authorities with the correct evaluation processes.

Hiram Moerman
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Together with Apeiron, your actual needs can be determined and a sound, future-proof, biocidal product strategy can be developed. The best-suited strategy will be established and put into practice.

A plan is drafted by evaluating your product composition, the regulatory status of the active substances present in your product, your full product portfolio, the intended uses and a wish list of the Member States where you want to place your products on the market.

WITHIN SUCH A PLAN THE FOLLOWING IS PRESENTED:

• The impact of active substances status on the applicable process,
• An insight in what your future biocidal product portfolio could look like,
• A proposal on the most appropriate application type, Union vs National authorisation, with or without mutual recognition,
• Data gap analysis,
• The impact of hazardous substances present in your products: SoCs? EDs?
• All you need in function of decision making.

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The regulatory landscape for biocides is complex and sometimes overwhelming, let us help you.

Tine Vandenbrouck
Contact Our Expert.

Biocidal products for which the active substance(s) are not yet approved but still under evaluation within the Review Program can be placed on the market when compliant to transitional (national) rules.

The advantage of this situation is that once the substance is approved and a new BPR dossier has been submitted, you may remain on the market during the evaluation phase of your new BPR dossier. However, the diversity of requirements, timelines and costs associated with the different processes in the different Member States under the transitional regime is enormous.

Is the active substance present in your biocidal product about to be approved? Or do you wish to market a biocidal product with an active substance that’s already approved? Together we can build your biocidal product authorisation dossier following the BPR requirements.

NATIONAL OR UNION DOSSIER BUILDING

Apeiron-Team holds all the expertise to build both single product dossiers as biocidal product family (BPF) dossiers, from A to Z. This includes:

• Think through the set-up of your BPF and metaSPCs,
• Data gap analysis,
• Study monitoring,
• IUCLID dossier building, incl. waiver generation,
• Exposure and risk assessment: human health & environment,
• Determination of SoC & evaluation of endocrine disrupting properties,
• Generation of draft PAR,
• Discussions with authorities throughout the process.

Start well and ensure the active substance used in your biocidal product is Art. 95 listed.

Are you interested in becoming an active substance supplier or biocidal product producer? We can help you to become Art. 95 listed.

THIS MEANS WE TAKE ON THE FOLLOWING TASKS FOR YOU:

• Contact data holders for verification of the Letter of Access Terms,
• Evaluate the substance identity profile of the approved Active Substance compared to your substance composition,
• When required, perform a technical equivalence assessment.

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To get your substance Art.95 listed in the right way.

Tine Vandenbrouck
Contact Our Expert.

Name it and we provide you with the support needed!

• Generation of a new active substance dossier,
• Support during the evaluation of your active substance dossier,
• Support in function of the renewal of your current active substance dossier,
• Or anything in between!

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To let us help you update specific sections of your dossier, generate additional exposure or risk assessments, monitor studies, …

Tine Vandenbrouck
Contact Our Expert.

Is your biocidal product authorisation about to expire or is your active substance up for renewal?

APEIRON-TEAM CAN SUPPORT YOU TO:

• Generate the newly required information,
• Update your dossier to the latest requirements,
• Check the status of your dossier in the function of ED (endocrine disrupting properties),
• Generate risk assessments for new uses.

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For any questions you may have on renewal of biocidal product authorisations.

Tine Vandenbrouck
Contact Our Expert.

Placing an article on the market which has been treated with or intentionally incorporates a biocidal product is subject to the requirements set out by the BPR. Not sure what to do or whether this applies to you? Read on…

Articles treated with biocidal products can only be placed on the market when containing active substances approved in the EU. This requirement applies since the 1st of September 2013! Furthermore, when you place a treated article on the market, you need to verify whether specific labelling requirements apply to you. In addition, you must be ready to communicate the necessary information to consumers.

WE CAN HELP YOU TO:

• Evaluate whether the treated article definition is fulfilled for your product,
• Identify your obligations,
• Define whether the relevant conditions are fulfilled for placing your treated article on the market.

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If you want to find out more!

Tine Vandenbrouck
Contact Our Expert.

The value of companies is not only affected by the current compliance level of their chemicals portfolio, but also by its regulatory outlook. The regulatory future of substances and even articles is affected by ongoing and scheduled regulatory efforts by authorities.

Hidden regulatory costs and regulatory risks can be identified based on the legislation and the legislative programs of the authorities. For a producer or a user of chemicals in key processes, an audit of the chemicals used, imported or manufactured can reveal this.

SCREEN COMPANIES EFFICIENTLY AND THOROUGHLY

• A Stakeholder intends to invest in a company wants to know if substances of very high concern are used in key processes,
• When taking over the position of product steward, an external compliance screening of the chemicals portfolio can help to build a targeted program to move forward,
• What is the impact of new legislative initiatives such as Green Deal on my business?

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Let us help you estimate the value of a company by analysing the current compliance level. We offer all the required expertise and experience to assist through the due diligence process.

Elke Van Asbroeck
Contact Our Expert.

Apeiron-Team uses standardised audit protocols to establish the reach and BPR compliance level of your company.

The compliance audit focuses on the current actual status of the implementation of a specific regulation. A compliance audit will thus provide the auditee with an overall view as to what extent his company or business unit complies with the regulation at that moment in time. Specific topics requiring further action to move towards full compliance will be identified. Apeiron-Team has developed compliance audit protocols for REACH and BPR. These protocols are inspired by ISO and follow the flow of the actual business processes for maximal audit efficiency and effectivity.

A REACH COMPLIANCE AUDIT WILL TYPICALLY FOCUS ON:

• The completeness of chemical inventories,
• The substance specific REACH obligations,
• The systems to sustain compliance.

Enforcement of EU regulations such as Biocides (BPR) or REACH is done by local authorities. Companies with REACH or BPR obligations can prepare for enforcement inspections taking into account the focal points decided by the joint Enforcement agencies in the EU. They can also prepare for such an inspection making sure that the required documentation is clear and available.

STRESSLESS ENFORCEMENT INSPECTIONS

Apeiron-Team has experience supporting companies during enforcement inspections and can help in the preparation of them. For this purpose, Apeiron-Team has prepared a standard protocol for preparation which can be checked and implemented during a pre-enforcement audit to get the best results. Such as pre-enforcement audit should be done independently of a scheduled enforcement inspection. Only this way, sufficient time can be assured to prepare properly and to correct any gaps.

KEY STEPS IN THE PREPARATION ARE:

• Understanding the scope of the inspection,
• Getting your team available,
• Checking the availability of the data.

Contact our expert

Get prepared for the inspection to make the most of all the effort your company has made to be compliant!

Hiram Moerman
Contact Our Expert.

Logic will get you from A to B,
Imagination will take you everywhere

Spending the right amount of money on compliance leaves more resources to go beyond. For this we are ready to look at the reality from another side! Going one step beyond in finding solutions can bring you from compliance to sustainable chemicals management.
We helped companies to save money by digging-in deeper into the questions to come with better solutions.

ONE STEP BEYOND

• There is no point to file a registration if an exemption is allowed!
• Is your money best spend on an application for authorisation or are there other options?
• What technology do you have in-house which can provide an answer to technological challenges elsewhere?
• Look at your chemicals portfolio with binoculars and see how they can support the sustainability of your business in the future.

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To get the best out of your knowledge and our expertise combined towards inspiring solutions for sustainable chemicals management challenges.

Hiram Moerman
Contact Our Expert.

BREXIT is a reality! The transitional period came to an end 31st of December 2020. New rules are already applicable as of January 1st 2021.

BREXIT has a huge impact on the regulatory landscape as we know it today. If REACH, BPR, CLP, PIC, PPP,… are applicable to you, it is important to evaluate how BREXIT is impacting your business. Knowing the actions you need to take to ensure compliance for years to come, is essential. Cost effective management of the changing requirements, while avoiding supply chain interruptions, is key.
Together with you we identify and evaluate the impact and optimum solutions. Our GB-REACH audit is tailor-made and highly efficient for identifying your needs.

SUSTAINABLE SOLUTIONS FOR THE INDEPENDENT UK CHEMICALS REGULATIONS

• Which regulation(s) apply to you today? REACH, BPR, CLP,...
• Which supply chain scenarios are applicable to you?
• EU/Non-EU => GB, GB => EU, GB => Northern Ireland,…
• What is the potential impact?
• What are your options to ensure compliance?
• What are your immediate and/or long-term actions?

Contact our expert

To help you deliver a clear overview of applicable timelines and a tailor-made action plan.

Mike Crawford
Contact Our Expert.

Be prepared for the impact of BREXIT on your UK REACH compliance! Act now and ensure business continuity!

As of January 1st 2021, the UK’s independent chemicals regulatory framework (UK REACH) applies. UK REACH maintains EU REACH’s aims and principles, and therefore manufacturers and importers in Great Britain will have to register their chemicals to ensure access to the GB market. Furthermore, companies in Great Britain are no longer able to place products on the EU market without first ensuring that compliance to EU REACH is maintained. It is very possible that many GB-based companies, currently EU downstream users of chemicals, will need to become registrants in either GB or the EU or both.

Apeiron-Team can provide support to ensure market access both for EU/EEA and GB based companies. In practice, this will come down to supporting you!

WITH THE FOLLOWING TASKS:

• Downstream User Import Notifications (DUIN),
• GB Registrations,
• 'Grandfathering' of GB held registrations,
• GB Authorisations,
• GB Only Representative service,
• EU market access for GB business.

Contact our expert.

To find out how we help you ensure compliance with UK REACH.

Tine Vandenbrouck
Contact Our Expert.

BREXIT not only has impact on the REACH process but also BPR related processes are heavily impacted by the decision of the UK to leave the EU.

Many actions have already been taken to prepare this transition. For example, the UK no longer acts as reference Member State or evaluating Member State under the BPR. All dossiers that were submitted or pending have been transferred to other Member States whenever needed.

The key question however remains… Which actions do you need to take to be compliant since the 1st of January 2021? Apeiron-Team can help you to determine the most urgent actions. Together we evaluate your full biocidal product/active substance portfolio.

SOME KEY QUESTIONS CAN BE POSED ALREADY:

• Are you GB-based and holding biocidal product authorisations in the EU? And currently listed on Art.95?
• Are you EU-based and currently listed on Article 95 but supplying to the GB market?
• Are you an EU-based product authorisation holder relying on mutual recogition to a GB authorisation?
• And many more ...

Contact our expert

To find out how you can ensure UK BPR compliance for your biocides portfolio.

Tine Vandenbrouck
Contact Our Expert.

Also the European CLP Regulation will get a ‘GB brother’, the GB CLP Regulation.

Compliance to this Regulation will be required for all businesses based in Great Britain (England, Scotland and Wales). As of the 1st of January 2021, GB will make its own decisions regarding mandatory classification and labeling. In practice this will be the counterpart of the European harmonized classification and labeling.

CHANGES FOR WHICH GB COMPANIES CAN START TO PREPARE FOR INCLUDE:

Contact our expert

Tine Vandenbrouck
Contact Our Expert.

BREXIT will impact your supply of chemicals into Great Britain.

The UK is not longer in the European Union! Companies who are currently exporting chemical products into Great Britain (GB) will face new obligations! As of the current time, an initial Notification of substance information will need to be performed by October 2021, followed by phased full Registration requirements, starting in October 2023.
To continue accessing the GB market, these obligations can be covered either by the UK customer importing the product or by a non GB-based company through the appointment of a GB-based Only representative.

Apeiron-Team offers Only Representative services in Great Britain and supports manufacturers outside of GB in understanding and fulfilling their obligations the evolving UK chemicals legislation. Aside from the compliance steps, we provide strategic management of the substances for both current and future ‘UK REACH’ obligations. We act as the UK-connected eyes of the manufacturer, keeping watch over the substance and pro-actively notifying of additional obligations or evolutions in the regulatory context.

Contact our expert

To discuss your needs and benefits for appointing an Only Representative in Great Britain!

Mike Crawford
Contact Our Expert.