Reach & CLP

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
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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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We offer a full range of REACH authorisation services! See our services page for more information.

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 your REACH authorisation strategy and for your successful application for authorisation.

The REACH 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 APPLICATION 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 including and R&D plan or a substitution plan (SP),
• A Socio-Economic Analysis (SEA) demonstrating the socio-economic benefits outweigh the risk

We offer a full range of REACH authorisation services!

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Our strength is that we have the in-house expertise to tackle all parts of the application. Consistency between the different parts of the application 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 inputs.
• 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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