The European Biocides Regulation: 2022 Update
Water disinfection and the systems that convey its distribution are essential processes to eliminate bacteria and other potentially harmful microorganisms to ensure an adequate microbiological quality of the water resource. Most strategies used for this purpose rely on chemicals capable of eliminating microorganisms in the water; such products are known as “biocides.”
Given their actions and functions, it’s easy to understand that the use of such substances could have undesirable effects on humans, animals, and the environment. For this reason, the European Union has established that products used for water disinfection, as well as all others classified as biocides, undergo increasingly stringent evaluation procedures and controls to minimize potential risks of harmful effects and ensure that these risks are duly balanced by real benefits.
These general principles have been formalized in the European Biocides Regulation (BPR, Regulation (EU) 528/2012), whose primary aim is to control and improve the biocides market at the community level, ensuring the highest level of protection for humans and the environment.
What are Biocides?
According to European legislation, a biocide is any chemical substance intended to destroy, eliminate, render harmless, or exert a controlling effect on any harmful organism. Therefore, a disinfectant dosed in any type of water to prevent the proliferation of microorganisms that potentially pose a risk to human health must be considered a biocide.
BPR: Why is a Biocides Regulation Important?
The text of the European Biocides Regulation was adopted on May 22, 2012, with application from September 1, 2013, subject to a transition period for certain provisions (including those related to in situ generated biocides).
As mentioned earlier, the BPR aims to harmonize the biocides market at the Union level, simplify the approval of active substances (i.e., substances with biocidal action), and the authorization of biocidal products themselves. The Regulation also introduces timelines and deadlines for evaluations, opinions, and decision-making at the member state level. Additionally, it promotes the reduction of animal testing by introducing data-sharing obligations and encouraging the use of alternative testing methods.
The BPR’s evaluation process is divided into two phases:
- The approval of the active substance, conducted uniformly at the Union level.
- The authorization of the biocidal product at the member state level, which can be extended to other member states through mutual recognition. Alternatively, a single authorization can be obtained at the Union level for the biocidal product.
In summary, the BPR regulates:
- The definition of an EU-wide list of active substances for use in biocides
- Authorization for placing biocidal products on the market
- Mutual recognition of authorizations within the Union
- Market availability and use of biocides within one or more member states or the Union
- Market entry of treated articles
In biocides, the European Commission, along with the competent authorities of various member states, is supported by the ECHA (European Chemicals Agency), which coordinates organizational and technical activities for biocides approval and authorization at the European level. Within the Agency, a dedicated committee (BPC – Biocidal Products Committee) has been established, composed of representatives from each EU member state.
Understanding Biocides: How Are They Organized and Classified?
The Commission has classified biocides into 22 different “product types” (PTs) based on their characteristics and specific functions. These PTs are grouped into four main categories:
- GROUP 1: Disinfectants Products intended to contain the action and spread of microorganisms dangerous to human and animal health
- GROUP 2: Preservatives Products designed to prevent microbial and algal development that can cause significant damage to various types of goods and artifacts
- GROUP 3: Pest Control Products intended to control harmful animals such as rodents, insects, birds, etc.
- GROUP 4: Other Biocides Products designed to control the formation and fixation of fouling organisms, antifouling for boats, and the disinfection and preservation of human or animal corpses
Il tuo fornitore è sulla lista (dell’Art. 95)? Sanipur c’è.
In water disinfection, Group 1 is of greatest interest, including product type PT5, which groups disinfectants for drinking water treatment.
When choosing a product for water disinfection, it is essential to ensure that the disinfectant under consideration has undergone the evaluation process described above and that the supplier marketing it is listed in the Article 95 register of the BPR. This register lists authorized suppliers of various active substances and specifies the type of product the authorization refers to.
Being an authorized supplier of a biocide is synonymous with guaranteeing the product’s quality, efficacy, and safety.
As required by the BPR for in situ generated disinfectants, Sanipur submitted its dossier to ECHA for the approval of monochloramine for treating water intended for human and animal consumption, meeting the deadline of September 1, 2016.
Sources:
http://www.salute.gov.it/portale/temi/p2_6.jsp?id=3558&area=biocidi&menu=biocidi
