Legal definition of the term “biocidal product” placed on the market is obvious. This definition is provided in Article 3.1 of the Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012. Under EU law, a biocidal product is, in principle, “any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by any means other than mere physical or mechanical action (…)”.
Thus, in relation to the basic core of the legal definition, a biocidal product is therefore understood as a product with a basic biocidal function.
This issue is also addressed by the Polish Act of 9 October 2015 on biocidal products. It mainly stipulates the conditions for using and making biocidal products available on the Polish market and the authority responsible for the application of Regulation 528/2012, i.e. the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
A very interesting example of the introduction of genetically modified organisms is the mosquito released in the United States, on which the biotechnology company Oxitec conducted research. It was about a ten-year battle for permission to carry out the experiment. The main reason for such a long process were the protests of Florida residents who feared the bites of the new insects and the disruption of the ecosystem. The whole experiment involves releasing a bioengineered male mosquito to copulate with wild females, which transmit many diseases through their bites, including yellow fever, dengue and the Zika virus.
Importantly, the modified insect does not bite and has a gene that, when passed to its offspring, kills the female’s offspring in the early stages of larval development. This will significantly reduce the wild population of this animal species. The Florida Keys Mosquito Control District (FKMCD) sees hope in Oxitec’s innovation, so its board of directors voted to continue the experiment. After presenting this cutting-edge idea, it is worth asking the following questions: could the legalization of such an experiment in the Polish jurisdiction be based on a biocidal product implementation procedure? After all, Regulation 528/2012 mentions microorganisms. Or maybe such technology should be submitted for registration and not merely a notification?
This situation shows us how different the regulation of molecular biology is in the European Union and in the United States. In Europe, the European Chemicals Agency (ECHA) based in Finland ensures the proper and safe use of chemicals. In addition, it regulates biocides. The European Medicines Agency (EMA), on the other hand, is responsible for the supervision and approval of medicinal products for human and veterinary use. A biocide must be approved before it can be placed on the market in the EU country. A product that will only be available in one member state only needs to be approved in that country. However, when a product will be marketed in more than one country, authorisation must be sought through the mutual recognition procedure. The registration of biocidal products under the national procedure consists of the following steps: firstly, it is the fulfilment of a number of conditions by the entrepreneur in order to obtain an authorisation, and secondly, it is the drawing up of a complete application for the marketing authorisation of the biocidal product. A fee must be paid for processing the application, and the process itself can take up to 6 months. Therefore, the very perspective of general regulations indicates that the legalization of just a conventional biocide based on a mixture of chemical substances is a very difficult business venture.
This is no different in the regulated market in the US. Oxitec’s case also points to the many difficulties in the process of getting approval for such an innovative idea. According to the press reports, in 2010 the company applied to the United States Department of Agriculture (USDA) for a field trial with genetically modified mosquitoes in Key Haven. In response to the request, the USDA stated that it had no jurisdiction over the issue. Then, in 2011, Oxitec made the same request to the U.S. Food and Drug Administration (FDA), which made claims of control over bioengineered insects. 5 years later, the agency approved the study, but Key Haven residents speak out against the project. However, they manage to keep the project alive thanks to votes from other parts of Monroe County. This was a watershed moment in the history of the entire study, resulting in the trial being conducted last month and the boxes of modified mosquitoes being set up.
Referring to the questions posed earlier, based on the study ‘Public perception of genetically modified animals – science, utility and society’, the researchers found that the European public has a negative attitude towards genetically modified animals.
They have a much more positive attitude towards modified plants.
A contentious issue is the legalization in Poland of an experiment similar to that conducted by Oxetic. The procedure for the implementation of a biocidal product focuses mainly on substances and mixtures whose purpose is to destroy harmful organisms. Their most important task is to have a basic biocidal function. Therefore, the introduction of biocidal products in Poland in terms of genetically modified organisms is a difficult issue that certainly needs detailed regulation and a change of attitude in European society.