INFOTOX - Consultores de Riscos Ambientais e Tecnológicos Lda.
                                                                Your Chemical Regulatory Partner

Our Biocides Collaboration Group aims to help companies (specifically SMEs) meet BPR compliance. 

Joining this Group helps companies reduce costs related to BPR product authorisations, while maintaining full ownership of their product authorisations.

All biocidal products placed on the European Union market must comply with the Biocidal Products Regulation (EU) 528/2012, abbreviated to BPR. This regulation applies from 1 September 2013 replacing the Biocidal Products Directive (98/8/EC). The BPR requires that all biocidal products placed on the EU must be authorized. 

A BPR product application for authorization is composed of a lengthy dossier with detailed information regarding the product’s efficacy, physical chemistry, analytical methods, toxicity to humans, ecotoxicity, environmental fate, human and environmental exposure to the product followed by human health and environmental risk characterization and risk management. 

Of all the EU chemical regulations, this is one of the most complicated and costly to comply with (even more so than REACH). Costs involved include regulator fees, testing needs, active substance compliance (i.e. LoA for active listed in BPR article 95), regulatory compliance advisory services as well as consulting services for technical support, dossier elaboration and submission. For product applications with the same active substance and similar product use, many of these costs can be shared between companies, and thus significantly reduce the overall costs of compliance for each company. 

How the Collaborative Group Works 

The objective of the INFOTOX Biocides Collaboration Group is simple: 

  • To reduce costs related to BPR compliance by preparing product dossiers for the same active substance(s) for different companies concurrently. 
  • To facilitate the link between biocidal product manufactures with Article 95 compliant active substance suppliers. 

Companies interested in the same biocidal active substance join the Collaboration Group specific for that active substance. INFOTOX works with each company in the Collaboration Group to identify data needed, discuss possible options for cost savings, assist with any testing that may be required, elaborate the technical dossier, do the dossier submission, and follow-up with the regulators until the authorisation decision is granted. 

Key steps involved: 

1 - Companies interested in a specific biocidal active substance, fill in the expression of interest form. 
2 – INFOTOX assess the information submitted and replies to each company directly by email. A Confidentiality Agreement is completed before any sensitive information is exchanged. 
3 – When a sufficient number of companies are identified that are interested in the same active substance and share similar uses, then an invitation to join an active substance Collaboration Group is sent to interested companies. 
4 - Companies interested in joining a specific active substance Collaboration Group confirm their interest by signing a Collaborate Contract. 
5 – INFOTOX works with each company to collect all information required, does the company specific technical dossier and submits it to the evaluating Competent Authority. 
6 – The company pays ECHA and Competent Authority fees. 
7 – INFOTOX provides follow-up technical services until the evaluation is completed.

Who should join the Collaborative Groups

This Collaborative Group was established to assist companies (specially SMEs) wishing to place biocidal products onto the EU market. It is thus of interest, but not limited to: 
- formulators, 
- manufacturers, 
- distributors, 
- retailers with own brands. 

Special discounts are available to members of: 
- AISDPCL – Associação das Indústrias de Sabões, Detergentes e Produtos de Conservação e Limpeza (The Portuguese, Soaps, Detergents and Maintenance and Cleaning Products Association) 

For more information, please fill in the Expression of interest form

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