EU Commission Rejects Authorisation of BOMBEX® PEBBYS® CS Over Health Concerns

Background and Application

In April 2016, Jesmond Holding AG applied for the mutual recognition of BOMBEX® PEBBYS® CS across multiple EU Member States, including France and Germany. The Netherlands was designated as the reference Member State responsible for evaluating the application. The product contains permethrin and is intended for professional use.

Key Objections and Evaluation

The primary objections raised by France and Germany were based on potential health risks due to the manufacturing process and the presence of harmful substances:

1. Manufacturing Concerns: The encapsulation process of the biocidal product involves a reaction that can lead to the formation of isocyanates and aromatic amines, both of which are toxicologically significant. France insisted that the applicant must provide data on any residual isocyanates and free aromatic amines in the final product. However, the Netherlands argued that such data was not required under current regulations.
2. Toxic Substances: The product was found to contain three non-active substances identified as persistent, bio-accumulative, and toxic (PBT), as well as very persistent and very bio-accumulative (vPvB): octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6). Germany and France raised concerns that these substances could have unacceptable environmental impacts.

Agency and Commission Findings

The European Chemicals Agency (ECHA) was consulted to provide an opinion on the presence of free isocyanates and aromatic amines in the biocidal product. ECHA concluded that while free isocyanates could be excluded after storage, the presence of aromatic amines could not be ruled out. These amines are classified as genotoxic carcinogens, raising significant health concerns.

Furthermore, the Commission found that the applicant did not provide adequate analytical methods for detecting and quantifying these harmful substances, making it impossible to assess the product’s safety fully.

Final Decision

Based on ECHA’s findings and the inadequacy of the applicant’s data, the European Commission concluded that BOMBEX® PEBBYS® CS does not meet the necessary conditions for authorisation under Article 19(1), point (c) of Regulation (EU) No 528/2012. However, the product was deemed to meet the condition laid down in Article 19(1), point (b)(iv) regarding environmental impact due to the low concentrations of PBT/vPvB substances.

The decision reflects the EU’s stringent regulations on biocidal products, emphasizing the importance of comprehensive safety data to protect human health and the environment. The applicant has been provided an opportunity to submit additional data, but as it stands, BOMBEX® PEBBYS® CS cannot be authorised for use in the EU.