together: the alliance committed to advancing regulatory compliance for ethanol based products

Join forces with companies from biocidal and other sectors, to strengthen your regulatory approach under the BPR framework for ethanol based products, and related regulatory fields'

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Stay compliant through collaboration. Build smarter and high-quality biocidal product dossiers, together

The together alliance is a strategic partnership between CEHTRA, VelTox Strategy Consultancy, and Steptoe, combining regulatory, toxicological, and legal expertise to support companies facing biocidal challenges, especially those involving ethanol under the Biocidal Products Regulation (BPR).

This alliance offers a trusted framework for companies in the biocidal and related sectors (such as cosmetics) to collaborate and share non-confidential information. It enables alliance members to optimise costs, exchange experience and knowledge, and benefit from collective expertise, while maintaining full control over their own dossiers.

By bringing together CEHTRA's regulatory and scientific competence, VelTox's toxicological know-how, Steptoe's legal proficiency, the together alliance can provide a comprehensive and proven approach helping clients achieve regulatory compliance across Europe (or where applicable, Great Britain).

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Which companies should consider joining the together alliance?

The together alliance welcomes any company from the biocidal industry or related sectors, using ethanol and/or any similar active substances regulated under BPR, Regulation (EU) No 528/2012.

The alliance is particularly interesting for:

Companies seeking support for product compliance under BPR
Manufacturers looking to share scientific and regulatory resources
Organisations aiming to reduce costs and efficiently address regulatory timelines, while maintaining dossier ownership of their BPR product authorisations.

Key benefits joining together alliance

Ancre 1

cross- disciplinary alliance

Benefit from the combined expertise from three complimentary fields: CEHTRA (regulatory strategy), VelTox (toxicology expertise), Steptoe (legal knowledge)

Tailor-made participation

Choose between individual dossier submission or consortium-based collaboration (BPF, WHO compositions, PT1).

Guaranteed confidentiality

The content of dossiers remain under the company’s full control, without any disclosure of confidential data.

Cost rationalization

Shared scientific and administrative efforts, providing transparent, predictable and reduced costs (up to 30% savings possible)

Proven track record

Rely on the alliance with all the right in-house knowledge to guide you in adequate advice on regulatory, scientific and legal aspects for EU BPR authorisations

Looking for guidance through the together alliance?

Find it here.

A substance can only be used for this if certain conditions are met:

The substance must be assessed and formally approved based on a scientific evaluation performed by European Chemicals Agency (ECHA) and the EU Member States. An active substance dossier includes comprehensive data on the substance’s identity, physicochemical properties, (eco-))toxicological profile, environmental fate, and intended uses.
The assessment must demonstrate that the substance is effective for the intended biocidal purpose and no unacceptable risks to human health, animal health, or the environment are found.
Once approved, the substance is included in the Union list of approved active substances, published by ECHA.

Only after these steps can a substance be eligible for use in the EU. CEHTRA’s expert team have a proven track record of preparing and submitting active substance dossiers (new approvals, renewals, Annex I inclusions, etc.) and supporting companies until successful approval is established.

To place a biocidal product or a biocidal product family (BPF) on the market in the EU, companies must prepare and submit a comprehensive dossier according to the criteria set by the Biocidal Products Regulation (BPR). These dossiers typically include data on physicochemical properties, efficacy, (eco-)toxicological hazard profiles and risk assessments. The submission can be made through national schemes or via the EU central authorisation process (ie. BPR procedure), dependent on the EU status.

With deep expertise and knowledge in the BPR framework, CEHTRA can assist in the entire process from dossier preparation, designing testing strategies, and managing the dossier until the successful authorization reached, allowing market access for biocidal products in EU and national markets.

The main goal of the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) is to ensure a high level of protection for humans, animals, and the environment, by harmonizing the process via an EU-procedure that allows improving the functioning of the market for biocidal products such as disinfectants, wood preservatives, pest control products, and antifouling products.

To sell these products within EU, companies must meet strict BPR requirements. Approval of active substances used in the products and biocidal product authorisations are mandatory before going to the market.

The complexity of EU requirements for biocidal products, including active substances used in these products, requires a dedicated understanding of the Regulation (EU) 528/2012. At CEHTRA, our experienced regulatory team is able to guide you in selecting the right steps towards full BPR compliance.

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together: an alliance assuring regulatory, toxicological and legal excellence

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together: the alliance committed to advancing regulatory compliance for ethanol based products

Stay compliant through collaboration. Build smarter and high-quality biocidal product dossiers, together

Which companies should consider joining the together alliance?

How can a substance qualify for use as an active substance for biocides in EU?

How do I place a biocidal product or a biocidal product family on the market in the EU?

What is the Biocidal Products Regulation (BPR, EU 528/2012) and who needs to comply with it?