According to Annex III title 1-13 of the Biocidal Product regulation BPR 528/2012 “summary and evaluation”, “a draft risk assessment is performed” and transmitted to the authorities in the marketing authorisation application (outside of the mutual recognition and simplified process, authorisation for the same product or parallel trade).
N.B. This evaluation is not isolated to the long-term period as it can also be required for transitional period authorisations in some European countries.
A risk assessment specific to biocides
Although the principle remains the same as for a risk assessment (three distinct steps), the methodology (scenario type, modeling tools…) is more specific to the field of biocides and makes it a unique evaluation. Find out these three steps with the links to the guidance/tools specific to biocides.
1. Hazards assessment
This part enables to determine the substances’ hazards required for the risk evaluation. The substances to take into account are chosen in two ways:
- This part enables to determine the substances’ hazards required for the risk evaluation. The substances to take into account are chosen in two ways:
- and the substances of concern that are not active substances but that play a role in the danger of the mixture (by their classification or their behavior). This choice can be difficult especially for substances that are hazardous to the environment as you must watch out for their impact on all environmental compartments.
You then have to search for the intrinsic properties of the selected substances. When the Competent Authority Reports of Active Substances are available, these must be taken into account to start from the same key descriptors (physico-chemical parameters) and toxicological hazard deciding factors (NOAEL, ARfD, ADI, AOEL, etc for human health ; NOEC, PNEC, etc for the environment) as the competent authorities. If not, a bibliographic search is required.
ECHA has developed guidance documents on this:
- Guidance on the Biocidal Products Regulation Volume III: Human health Part A: Information Requirements Version 1.1 November 2014
- Guidance on the Biocidal Products Regulation Volume IV: Environment Part A: Information Requirements Version 1.1 November 2014
Expert know-how is important however as today, all guides required for this step, especially regarding the selection of substances of concern, have not yet been published.
2. Exposure assessment
This part consists in developing exposure scenarios (ES) to determine the level of exposure to man (professional and/or consumer) and the environment (for the different compartments: sediment, surface water, soils). These scenarios are determined according to the use of the biocidal product, and the exposure estimation can require 2 stages:
- a first model, Tier 1 based on the Emission Scenario Document (ESD) developed by ECHA for each product-type (PT). A model of the exposure is then required, from tools like Ecetoc TRA, MEASE, CONSEXPO, EUSES, ART, Stoffenmanager or Riskofderm. Moreover, ECHA has developed tools to estimate the environmental exposure for certain PTs, under Excel files.
The complexity resides in the fact that the use of the same software (EUSES for example) can be completely different according to the PT of the BP. - - a second model, Tier 2, consists in refining the exposure estimation and the corresponding risk, in case Tier 1 depicts an unacceptable risk for human health or the environment.
3. Risk characterisation
This conclusion on the chemical safety assessment consists in comparing threshold values in terms of exposure (risk characterisation ratios, RCR) or a qualitative assessment for certain specific substances. It must enable to conclude that the risk is managed with regards to man and the environment.
If the risk is not managed, the hazard or exposure assessment will be reviewed in order to conclude on risk management. Note that the first data amended within this iterative approach are those on the use (use frequency, use quantity…).
ECHA has developed guidance documents on this:
- Guidance on the Biocidal Products Regulation Volume IV Environment - Part B Risk Assessment (active substances) Version 1.0 April 2015
- Guidance on the Biocidal Products Regulation Volume III Human Health - Part B Risk Assessment Version 2.0 October 2015
The following guidance documents are expected in early 2017:
- Guidance on the BPR: Volume III Human Health, Part C Evaluation
- Guidance on the BPR: Volume IV Environment, Part C Evaluation
The methodology, the data used and the assessment results are compiled in the pre-assessment of risks report. This draft assessment or preliminary assessment will serve as a basis for the authorities to establish their own assessment which will be under the standardized format of the Product Assessment Report.
Do you want to learn more on biocidal risk assessment?
Please feel free to contact us at contact@ecomundo.eu or by phone at +33 (0)1 83 64 20 54. Our experts will be glad to answer to your questions.
