Points of Concern in the Review of SilverContaining Active Substances under Regulation 528/2012

The review of silver containingactive substances (SCAS)under Regulation 528/2012 (BPR) has raised the following important issues of consistency and proportionality in the regulation of the biocidal uses of silver, but which have implications for the review of active substances more generally, and should be addressed by the Competent Authorities.

1) Evaluation of silver in the EU under different chemicals legislation

Silver is used in industries that are regulated under REACH, Pesticides and Biocides. A consistent approach to the setting of reference values is desirable scientifically and to ensure that risk management is applied equally in each sector. Currentlybiocidal uses are treated with a significantly higher levelof caution.

The European BPR Silver Task Force (EUSTF) encourages discussion between ECHA and relevantAuthorities to develop a consistent approach.

2) Cumulative tonnage based environmental exposure model for treated articles

The environmental risk assessment model for silver is tonnage based and is cumulative for the eightSCAS under review and the product types supported for treated articles. Cumulative assessment is foreseen in the BPR but the method applied to theSCAS lacks transparency and results in overly conservative conclusions for treated articles. Detailed regulation of treated articles is not required for active substance approval and reliance on a single cumulative assessment discriminates against SMEs in the silver market.

The EUSTF wouldappreciate a clear statement of the policyapplied by CA to treated article regulation.

3) Silver from other industries, background silver and aggregated exposure

Environmental exposure and effects predicted for the biocidal use of silver are exaggerated in comparison to other natural and man-made sources of silver. Risk management guidance from ECHA in relation to aggregate exposure is incomplete.

The EUSTF would welcome guidance from CA on how proportionality is applied under the BPR.

4) Risk envelope approach to human health exposure modelling

The use of risk envelopes to categorise treated articlesfor human health risk assessmentis applied to the review of silver substances,in the absence of EU guidance and data requirements. If endorsed through BPC,the review of silver substances will likely set a precedentfor other active substances with treated article uses. Risk envelopes for human health risk assessment have been discussed previously at CA.

The EUSTF asks the CA if treated article risk envelopes represent an agreed EU approach to risk assessment.

Further details on the issues highlighted above are provided in the attachedAnnex.

ANNEX

1) Evaluation of silver in the EU under different chemicals legislation

  • The issue of a consistent evaluation of silver under Biocide, REACH and Plant Protection regulations was raised by the EUSTF at the 58th CA meeting in November 2014.
  • Of concern are the derived PNEC values for the environment, in particular the different treatment of sediment data and the veryhigh level of conservatism applied to data under the biocide evaluation.

End-Point / REACH / Plant Protection / Biocide
Surface water / HC5 = 0.119 µg/L
species sensitivity analysis based on 16 species across different trophic levels
AF = 3
PNEC = 0.04 µg/L / NOEC = 0.24 µg/L
deterministic assessment from lowest available NOEC for fish
PEC = 0.01 µg/L
TER = 24
Annex VI trigger = >10 / NOEC = 0.08 µg/L
deterministic assessment based on geometric mean for most sensitive species (fish)
AF = 10
PNEC = 0.008 µg/L (i.e. 5 times lower than REACH)
Sediment / NOEC = 12000 µg/kg dw based on Hyalellaaztecagrowth effects
AF = 10
PNEC = 1200 µg/kg dw
Normalised to 5% organic content to give a derived PNEC
PNEC = 438000 µg/kg dw / Limited data
Further data not requested based on low exposure / NOEC = 441 µg/kg dw deterministic assessment based on Lumbriculus body weight effects
PNEC expressed in wet sediment equivalents, dw/ww conversion = 4.6
AF = 10*
Organic carbon normalisation not performed
PNEC = 9.58 µg/kg ww (i.e. 45,720 times lower than REACH)
Organic carbon normalisation not performed under biocides
Soil / HC5 = 3290 µg/kgdw
species sensitivity analysis based on normalisation of soil ecotox data to EU soil types
AF = 3
PNEC = 1100 µg/kg dw / Limited data
Assessment could not be performed but not highlighted as a critical area for concern in the EFSA conclusions document / NOEC = 280 µg/kg ww deterministic assessment based on suppression of soil carbon respiration
AF = 50
Normalised to standard soil organic content to give a derived PNEC
PNEC = 12.0 µg/kg ww (i.e. 92 times lower than REACH)

AF = Assessment Factor
* subject to confirmation at BPC WG June 2015, alternative proposal is AF= 50.

  • A small concern (PEC/PNEC ratio = 3.3) for the sediment compartment is indicated for biocidal use based on the current evaluation of exposure and effects by the eCA. The exposure model used by the eCA indicates that restriction of silver treated textiles is the method desired by the eCAto mitigate sediment effects.
  • The amount of silver used in treated textiles is a negligible fraction of the total amount of silver used in domestic and industrialnon-biocidal applications. The eCA dismisses the environmental impact of non-biocidal uses of silver despite monitoring data showing significant historical input from human use, and instead points to the incremental use of biocidal silver as the ‘tipping point’ of concern.
  • The likely goal of environmental protection through restriction of textiles treated with silver will be overstated by the eCA and the EUSTF is concerned that rigid application of the BPR will lead to disproportionate regulation of this important market.
  • During MS commenting on the CAR for silver zinc zeolite, NL reminded the eCA of the need to harmonise the REACH and Biocide end points for the environment. The eCAacknowledged the need, but no further action or discussion was proposed in the RCOM. This point was also discussed in the tripartite meeting between ECHA, the eCA, and the EUSTF with agreement for dialogue between the eCA and ECHA.
  • The EUSTF requests that environmental effects of silver are aligned between the respective chemical legislation to ensure regulation is applied consistently according to available scientific knowledge.

2) Cumulative tonnage based environmental exposure model for treated articles

  • The eCA uses a single cumulative modelbased on the total EU tonnage for the eight notified SCAS to calculate environmental exposure from articles treated with silver. The model derives a single PEClocalvalue for each environmental compartment which is compared against the relevant PNEC in the risk assessment. The eCA justifies this approach based on wide dispersive use of treated articles and the likelihood of an underlying background concentration of silver coming from biocidal use.
  • Article 8(3) of the BPR directs that cumulative effects from the biocidal products containing the same active substances shall be taken into account, where relevant. In the approach taken by the eCA the active substance is considered to be ‘silver’ and not the individual notified SCAS. The eCA uses only the cumulative assessment.
  • The notified SCAS will be authorised separately with individual CARs prepared by the eCA and individual BPC decisions. Currently there is no separate evaluation of the environmental risks for each SCAS and without this relative risk cannot be determined and there is no mechanism for comparative assessment of the SCAS (including new SCAS) post approval.
  • Cumulative tonnage exposure assessment relies on the collective use of confidential market data from the individual SCASnotifiers. This approach lacks transparency and disproportionately affects those companies (likely to be SMEs) that place low quantities of silver on the market, or companies that use low quantities of silver as a consequence of technological innovation.
  • In the risk assessment the eCA makes a distinction between treated article use in textiles and treated article use in solid polymer applications (with either high or low water contact). In this regard the evaluation is focused on regulating treated article uses of silver in general, rather than identifying safe uses for the individual SCAS.
  • The exclusive use of cumulative exposure modelling by the eCAwas questioned by other MSCAs (UK and NL) during commenting on the draft CAR for silver zinc zeolite, but the eCA opinion prevents further discussion at WG (point closed in the RCOM).
  • The EUSTF is concerned that relying only on cumulative exposure is an overly conservative risk assessment method for the environment. The EUSTF agrees that cumulative exposure should be considered, but it should follow a separate evaluation of the individual SCAS and be placed in context compared to other man-made inputs of silver into the environment.

3) Silver from other industries, background silver and aggregated exposure

  • Recent ECHA guidance[1]on risk assessment contains reference to biocide substances that occur naturally or have releases coming from other non-biocidal sources. A common EU approach to handle this situation has yet to be agreed.
  • The amount of silver used by the EUSTF companies in biocidal products is small, representing <1% of the total EU consumption of silver.
  • Background levels of silver in the environment are significant in comparison to the eCA modelled PEC values and the PNEC values concluded by the eCA are lower than background levels.
  • Where risk characterisation shows PEC/PNEC ratios greater than one, the ECHA guidance document recommends the importance of having information on the natural and/or ambient background levels in order to decide upon further actions to be taken to reduce the risks.
  • The EUSTF is concerned that highly conservative exposure assessments by the eCA will result in regulation of silver that is disproportionate compared to the existing levels of silver in the environment and the contribution from other sources of silver.
  • Recent ECHA guidance[2] suggests that aggregated exposure is only necessary when the biocidal use of a substance is significant in comparison to other sources and where the emission pattern for the biocide is specific. It is the opinion of the EUSTF that neither of these criteria applies to silver.

Guidance on the principles for the approval of active substances[3] states that “restrictions concerning the use of the active substance in treated articles are introduced only where a major concern is identified”. It is the opinion of the EUSTF that the level of risk to the environment caused by the use of silver in treated articles (especially textiles) is not of major concern if the highly conservative method of assessment and other sources of silver are properly considered.

4) Risk envelope approach to human health exposure modelling

  • The eCA has in the past presented a position to the EU Commission on the approval of active substances used in treated articles[4]. The position proposeduse-categories (risk envelopes) within which conditions for approval can be defined.

  • The eCAposition on risk envelopes was developed during evaluation of the SCAS, allowing the eCA to implement policy objectives and shape the silver evaluation in line with these objectives.
  • The eCA defines the boundaries of the risk envelope in terms of the route of exposure, exposure duration, area of contact and potential user group(s). Highly conservative assumptions are used, in particular the eCA/MS agreement to compare acute exposure with chronic effects.
  • Data which might normally be presented at Product Authorisation is lacking (since this approach was not anticipated at the outset) which would reduce the need for conservative assessment. The concept of one safe use is not being applied to the active substance review.
  • The EUSTF is concerned that the treated article uses of silver are being regulated in the absence of approved guidance and the methodology adopted by the eCA applies multiple levels of conservatism resulting in exaggerated risk.
  • Based on the evaluation by the eCA, the EUSTF has no clear indication of the future market for silver treated articles. There is no guidance on whether the risk envelope concept proposed by the eCA will be accepted for EU biocide regulation and if accepted how this will be translated into regulation of the treated articles market.

1 of 5

[1] BPR Guidance, Volume IV Environment - Part B Risk Assessment (active substances)Version 1.0, April 2015, Section 4.6.

[2] BPR Guidance, Volume IV Environment - Part B Risk Assessment (active substances) Version 1.0, April 2015, Section 4.7.

[3] CA-Sept13-Doc.3.0 – Final.

[4] CA-Feb13-Doc.5.1.h – Treated Articles.