Consultancy – professional services – support for authorisation of biocidal products
Biocides (biocidal products) – we offer you the preparation of the documentation necessary for the authorisation of biocidal products under the BPR for the market of EU member states – contact us at our contact addresses: ekotox@ekotox.sk, by phone: +421 2 45943712.
The basic principle of the BPR is that a biocidal product (BP) must be authorised before it is made available on the market or used in the European Union (EU) / European Economic Area (EEA).
If you are planning to sell their biocidal products in one EU Member State must apply for product authorisation in that country. To do so, they submit an application for authorisation through R4BP.
You can choose between several alternative processes, depending on their product and the number of countries where they wish to sell it.
- National authorisation and mutual recognition : If you wish to place the biocidal product only on a single market, authorisation from that country is sufficient. If you wish to place the biocidal product on the market in several countries, it can apply for mutual recognition for the BP authorisation.
- Union authorisation :Union authorisation can be granted to biocidal products with similar conditions of use across the Union, except those containing active substances meeting the exclusion criteria and those belonging to product-type.
- Simplified authorisation :A simplified authorisation procedure aims to encourage the use of biocidal products that are less harmful for the environment, human and animal health. To be eligible for the simplified authorisation procedure a biocidal product must comply with all of the following conditions:
- BP contains the active substances contained in the Annex I of the BPR
- BP does not contain any substance of concern
- BP does not contain any nanomaterials
- BP is sufficiently effective
- the handling of BP and its intended use do not require personal protective equipment
Same biocidal product authorisation: If you wish to placet he biocidal product that is either identical to an already authorised biocidal product or identical to the biocidal product for which authorisation is currently being sought.
The authorisation process includes consecutive steps.
SCOPING ASSESSMENT
- Analysis of the biocidal product, including control of the active substance contained in the BP in view of the need for authorisation of the BP;
- Analysis of the availability of the Letter of Acess (LoA) in order to obtain consent from the data owner for the active substance contained in the BP.
Letter of Acess (LoA) means an original document signed by the data owner or his representative stating that the data may be used for the benefit of a third party by the competent authorities, the Agency or the Commission for the purpose of authorisation (Article 3(1)(t) BPR.
DATA GAP ANALYSIS
- Financial analysis and authorisation plan timing;
- Identify processes in the company;
- Process of identifying the non-compliance between the current state and the desired state of your data;
- Proposal the next steps to obtain the required quality of documentation for a successful BP authorisation process.
STRATEGY DEVELOPMENT AND APPROVAL, DATA GHATERING
- Cooperation in securing missing tests, studies, data, communication with laboratories
- includes laboratory testing, test results;
- Elaboration of SDS, labels and instructions for use.
EVALUATION AND REPORTING, EXPOSURE &RISK ASSESSMENT
- Risk Assessment for the BP- active substance and “substances of concern“ by using monitoring data and models.
Substance of concern means any substance, other than the active substance, which has an inherent capacity to cause an adverse effect, immediately or in the more distant future, on humans, in particular vulnerable groups, animals or the environment and is present or is produced in a biocidal product in sufficient.
DOSSIER DEVELOPMENT, R4BP SUBMISSION
- Development of a dossier for BP authorization in IUCLID;
- Processing SPC (Summary of Products Characteristic);
- Creation of REACH-IT account;
- Submission of registration documentation via R4BP;
- Communication with Assessment Authority.
FOLLOW-UP
- Cooperation and communication with the customer in case of the need to supplement or change some data