PT 21 product authorisation guidance
Date of draft: 01 March 2017 / Agenda point: 7.3b
For discussion / Document No. CA-March17-Doc.7.3b
During the 55th CA meeting of March 2014, a general approach was agreed concerning the management of antifouling PT21 active substances and biocidal products[1]. Considering the need for antifouling active substances and biocidal products (i.e. to prevent the growth of marine life on ships and boats allowing their safe and efficient operation, prevention of spreading of invasive species, as well as reducing fuel consumption and related greenhouse gases emissions), some risks were accepted by the majority of Member States (ex: levels of risks in the harbour or marina during the service life), noting that such risks might not be accepted anymore over time. To enable efficient authorisation and mutual recognition of biocidal products, it was also agreed that with regards to decisions related to protection of the environment, the risks related to the in-service life phase of products on commercial shipping or superyachts >25 m should be harmonised across the EU. Such harmonisation was recognised as being important for these uses, where ships treated in one MS can be expected to travel across the EU. However it was also agreed that more experience needed to be gathered during the product authorisation phase. The same expiry date of 31/12/2025 was set for existing PT21 active substances, in order to be able to review the approval of these substances at the same time, and revise the approach to risk assessment and mitigation at the renewal stage where appropriate.
Further work has been made at technical level in order to better assess antifouling products. ECHA BPC's Environment WG asks the CA meeting to discuss the questions referred in the present document.
Introduction
A number of new and existing active substances used in Product Type 21 (antifouling products) have been successfully reviewed under the biocides legislation. To support inclusion on the EU approved list safe uses for the environment were based on risk assessments using the OECD Emission Scenario Document (2004). The assessments supporting substance approval used the individual OECD harbour and marina scenarios, selected as being representative of commercial shipping and pleasure craft respectively. Risk characterisation was based on concentrations predicted in the areas immediately surrounding these OECD scenarios and did not use information on concentrations inside marinas or harbours for decision making. However it was recognised that this approach was only an interim measure that was necessary to allow the active substance review process to progress in line with legislative timelines. MS experts at the BPC Environment WG acknowledged that this approach would need to be re-discussed before products could be authorised under the BPR.
Within the BPC Environment WG, the UK and NL have led a project to develop a specific product authorisation manual focussing on environmental risk assessment to resolve the technical issues that remained at the end of the substance approval process. This manual aims to harmonise approaches at product stage, improve consistency and reduce MS and Applicant workloads by supporting Mutual Recognition procedures. The project has successfully resolved many issues and it is the intention of the BPC WG to present the final agreed version of the product manual at a future CA meeting prior to adoption. A key part of this project has been to develop new scenarios for pleasure craft uses that better reflect the variability in environments and exposure levels across contrasting EU regions and to ensure adequate levels of protection when assessing risks at product authorisation stage. Before finalisation of the product manual and confirmation of the associated pleasure craft scenarios to be used to support product authorisation, the CA meeting is being asked to consider the potential implications for decision making and the overall regulatory impact of the proposals being made. In particular the CA meeting is asked to consider if agreements reached in 2014 on the acceptance of risks would need to be revisited now (before the first products are authorised under BPR) or whether these agreements should be left in place until substance renewal phase.
These issues are now of critical importance as product authorisation submission deadlines for PT21 products is now coming. The dates of substance approval for copper, dicopper oxide and copper thiocyanate are all 01/01/2018. Since most existing PT21 products contain mixtures of active substances including one of these copper variants, Applicants must apply for product authorisation under BPR by 01/01/2018 in order to keep existing biocidal products on the market.
Finalised product guidance is urgently needed to allow Applicants to make regulatory compliant applications by the deadline.
Further information and key questions for the CA members are outlined below.
Analysis of regional pleasure craft marina scenarios
As highlighted above risk assessments supporting active substance approval were based on the single OECD marina scenario with concentrations reported for the areas surrounding the marina. BPC WG MS experts acknowledged this to be an interim measure and that further work was needed to assess the appropriateness of this approach to support product authorisation decisions. It should be noted that the OECD marina scenario was developed based on information from a variety of sources, but is considered most representative of a typical French Mediterranean pleasure craft marina. The relevance of this single marina to other EU regions has been consistently questioned by BPC WG experts.
Within the BPC Environment WG, the UK therefore led a project on analysing pleasure craft marinas across different EU regions. The summary technical report was discussed at BPC WGI 2017 and has been included as Appendix A for information. In brief the UK analysis utilised data collected from 148 marinas across the main EU regions (Atlantic, Mediterranean, Baltic Transition and Baltic Sea). An example of the key parameters of marinas sampled from the Atlantic Region is shown in Appendix A, Table 3, page 12. These data were used to simulate concentrations using the MAMPEC model (the same model as used for substance approval assessments and as recommended by the OECD ESD). Average concentrations inside the individual marina environments and in the surrounding areas were reported (see example for the Atlantic Region in Appendix A, Table 7, page 18). The results indicated that it would be very difficult to identify appropriately conservative individual pleasure craft marina scenarios in each region. This was because the sensitivity of the modelled scenarios was shown to be highly substance specific. As such a single scenario that may be appropriate for one substance would not necessarily be appropriate for another substance with contrasting chemical properties. Note these results were based on testing only two contrasting substances, but are likely to be broadly representative of the full range of active substances under future consideration at product authorisation stage.
The results also indicated that the existing single OECD marina scenario gave highly variable levels of protection across the four regions when compared to the results of the analysis of additional regional marinas. For example in the Baltic Sea Region, concentrations predicted using the existing OECD marina scenario were equivalent to only the 2.92 percentile of the distribution of concentrations predicted for actual Baltic Sea marinas included in the analysis (see Appendix A, Table 10 page 23). In contrast, in the analysis of Mediterranean region the OECD scenario was equivalent to the 99.5 percentile of the distribution of concentrations predicted from analysis of Mediterranean marinas. In either situation the BPC WG experts agreed that the levels of protection afforded by the OECD marina scenario were inappropriate. In addition experts agreed that new scenarios that are more representative of all EU regions should be defined. Similar findings were made when comparing the modelling results from proposed generic regional marinas whose properties were defined from the average parameters of all individual marinas within each region. Again a single average regional marina was unable to provide a consistent level of protection for both substances tested in each of the four regions.
Due to the difficulty in identifying appropriately conservative individual pleasure craft marina scenarios in each region, the UK proposed the development of a substance specific exposure assessment tool that would allow relatively easy calculation of concentrations in all 148 marinas, separated into the four regions. A prototype tool for calculating concentrations of dicopper oxide (one of the main PT21 active substances) has been developed using MS Excel and testing has been undertaken. Separate tools will need to be developed for each substance. These tools will allow the calculation of appropriate percentile concentration values from the underlying distributions of concentration values for each approved active substance. Each tool will be able to report any percentile value chosen by the user (e.g. 90th percentile, 50th percentile etc.). An example of the type of distribution calculated is shown in Appendix A, Figure 2 page 26. It should be acknowledged that this work has been based on a relatively limited set of marinas in each region. Within the constraints of the UK analysis work it was not possible to extend the analysis to a much wider set of marina conditions. As such it is not really possible to conclude on how the percentiles from the modelled distributions relate to the actual statistical populations of concentrations in the real environment on either a spatial or temporal scale. However a number of conservative worst case assumptions have been retained within the modelling framework that give some confidence that the approach is likely to provide a conservative estimate of actual exposure distributions in the real environment.
The intention of the original work on the product authorisation manual was to identify a limited set of core scenarios that could be used by all reference MS when assessing future products. This would aid Mutual Recognition for those MS who were able to accept that the core scenarios were protective of their own environmental conditions. The development of the Excel calculator tool capable of estimating concentrations in multiple marinas per region has added a degree of complexity to this part of the product manual. However the philosophy remains the same in that the future guidance intends to recommend that all reference MS take a harmonised approach to performing the core assessment based on the individual substance calculation tools.
The product manual also envisages that some MS may wish to define additional National specific scenarios that are more protective or realistic of their own environmental conditions. Whilst the development of MS specific scenarios was outside the scope of the UK analysis work, the BPC WG recognised the importance of identifying a harmonised approach to the core assessment as well as allowing this additional degree of flexibility with regards MS specific issues.
The BPC WG experts agreed with the overall UK analysis (see Appendix A) and that the approach to scenario identification was more robust than in the existing OECD ESD. As such the BPC WG experts agreed to the use of the Excel calculation tool to support the core assessment in future product evaluations. However critical issues remained over the scope of the core risk assessment as well as over the use and selection of appropriate values from the described concentration distributions which should form the basis of core regulatory decisions at the product authorisation stage. Since more information is now available on the levels of protection afforded by the OECD marina scenario across different EU regions, it may also be appropriate to reconsider the agreements reached at the 55th CA meeting of March 2014. The BPC WG agreed that it would be appropriate to consult risk managers at the CA meeting on these key issues and these are therefore outlined below.
1. Issue 1: Assessing risk based on concentrations inside marinas or only in the surrounding areas
The BPC WG experts proposed that for the purposes of developing a new approach to product authorisation risks assessment should be based on the concentrations predicted inside pleasure craft marinas. The advantage of this approach is that it ensures a high level of protection of the environment as required by Regulation 528/2012. Marinas may themselves represent important environments worthy of protection. Marinas may also act as sedimentation areas for contaminated particles and as accumulation sites they may act as hot spots for wider contamination via resuspension. Even if marinas would not be viewed as environments worthy of protection, they may be seen as representing transition zones between the target or impacted site and the wider environment (non-target or non-impacted site) that is viewed as worthy of protection. As such these transition zones may be regarded as being appropriate areas upon which to base risk assessments using the precautionary principle enshrined in the biocides regulation.
The disadvantage of basing risk assessments on concentrations inside marinas would include the fact that this approach is inconsistent with the current decision to base risk assessments on concentrations only in surrounding areas reached at the 55th CA meeting of March 2014. Analysis of the OECD marina scenario typically shows that concentrations predicted in the surrounding areas are around 100 times lower than those predicted inside the marinas[2]. The analysis of the additional regional marinas indicated that the ratio between concentrations inside the marina and in surrounding areas was typically much higher than this with concentrations often several hundred or even several thousand times lower in surrounding areas. Due to the significantly higher concentrations predicted inside marinas, the decision to utilise these concentrations in regulatory assessments at product authorisation stage is also likely to have the largest regulatory impact on which products show acceptable risks, and which product show unacceptable risks.