Dutch comments on CA-May15-Doc 7.3a “Developing a policy approach for the establishment of maximum residue levels for residues of active substances contained in biocidal products”
Bilthoven, 9 July 2015
General comments
The Netherlands are pleased to see that the MRL discussion is advancing and thank the Commission for drafting this note for discussion, as we urgently need a procedure for the establishment of MRLs for biocides. However, we do not agree with all details of the proposal. We fully support the general and detailed comments made by Germany (Bundesanstalt fur Arbeitsschutz und Arbeitsmedizin, Dortmund, 17.05.2015), since these comments fully reflect our opinion in this matter.
Default MRL
In the present situation, no quantitative data on biocide residues in food or feed and no analytical methods are provided upon biocide active substance or product authorisation. Therefore a proper dietary exposure assessment cannot be conducted because of lack of data. We are of the opinion that setting a default MRL of 0.01 mg/kg for biocides with a transitional period could be an excellent instrument to get data on biocide residues in food and feed. This transitional period could be used by industry to test for biocide residues in food and feed and by Member States to set up a monitoring program. In this way, areas in the food and feed industry, where biocide residues may be an issue will be identified. For such cases a higher MRL may be derived to cover the envisaged biocide use or may be reason to search for better alternatives (e.g. non-chemical means). Any problems in analytical methodology will show up and may be reason to either raise the default MRL or improve analytical methodology. At the Conference on MRL Setting for biocides in March 2014, many participants were in favour of setting such a default MRL and to set biocide MRLs under the Plant Protection Products Framework. The presented policy approach, however, does not discuss setting a default MRL for biocide residues or setting MRLs under Regulation (EC) No 396/2005.
Dietary risk assessment model
Apart from the MRL setting thought should be given to a suitable dietary risk assessment(DRA) method. Generally, in these methods exposure levels are compared to the ADI, ARfD or another toxicological reference level. Although ARTfood develops guidances how to estimate residues in food, at present no proposals have been made regarding which consumption model should be used to calculate the exposure (residue x consumption). The different frameworks mentioned (PPP, VMP, contaminants, Food Additives) use differently defined (more and less refined) dietary intake sources. The Netherlands prefers to use the Food Additive Budget Method in case foods are not specified in the intended biocide product label, and the Food Additive FAIM model in case specific foods are addressed in the biocide product label. The slides presented on this issue during the MRL workshop in Germany are added as appendixto clarify this point.
ARTfood mandate
It is noted that the mandate of the ARTfood working group is limited to residues in food. As such the ARTfood working group does not cover the dietary risk assessment (consumption models, toxicological reference values). In order to make more progress in the development of the guidances for professional use, there is an urgent need for an EU dietary risk assessment partner (e.g. EFSA or EMA or EU-COM) to be assigned to ARTfood.
Detailed comments
These comments should be read together with the German detailed comments of 17.05.2015.
Point (9)See German comment
Point (10)See German comment
Point (11)Ensuring a high level of protection of both human and animal health and the environment, is a key purpose of the BPR.In addition, in our opinion, sustainable use of biocides (highlighted in article 18 of the BPR) should be one of the key purposes as well (e.g. replace a biocide use by a non-chemical treatment, to avoid biocide residues in food). It is proposed to address this point here as well.
Point (12) Though biocides are not intended to be used directly on food, the use of biocide products in settings where contact with food and feed is possible,is intentional and in certain uses residues in food can therefore be expected. Furthermore, specific use conditions must be met. If the specific use conditions are not followed properlyto save time and money (e.g. rinsing steps to remove the biocide product before food production may be skipped)this results in unnecessary high levels ofbiocide in food or feed. Best practices should be followed as a means of reducing the residues of biocides in food to a minimum. Best practices are described in the label instructions, comparable to the GAP for Pesticides.
Point (14)NL agrees that biocide residues are more likely to be found in processed or composite food. But the presence of biocide residues cannot be ruled out in/on raw agricultural products, especially when biocides are used in storage facilities (disinfectants, insecticides)
Point (16)In order to protect human health, residues of active substances in food should under normal conditions of use be as low as reasonably achievable. Operators should therefore take measures (such as rinsing) in order to reduce residues in food as much as possible. A MRL should consequently be set on the basis of the ALARA principle. Because consumers can be exposed to an active substance via several exposure routes and there is limited scientific knowledge on the magnitude of this aggregated exposure and its risks, it is prudent to reduce exposure from biocide residues to a minimum. Also, there is little coordination between legal frameworks in relation to aggregated exposure and risk assessment.
Furthermore, in future uncertainty regarding risks of cumulative exposure should also be taken into account and this is another argument against choosing an approach based on allocating a fixed part of an ADI or any other toxicological reference value to exposure from biocide residues.
Point (17a)See German comment
In addition, NL does not agree with the assumption that biocidal substances that are also used as feed additives represent no potential consumer risk. Feed additives follow a different route (first consumption by the animal and then consumption by humans via meat, milk or eggs) compared to the same biocidal active substance present in human food (direct consumption by humans) and consequently that use of feed additives within allowed limits for feed may not guarantee that residue levels in human foodare safe within the same range.
Point (17c)See German comment
Point (17e)See German comment
Point (20&21)See German comment. As defined correctly in point 20, the ADI is an estimate of the residue that can be ingested daily over a lifetime without any appreciable health risk. The ADI can be used as a toxicological reference value that can be compared with expected daily exposure (in this case residue) estimates. This should however, be driven by established (controllable) use and not primarily by filling the ADI to a certain extent. See also comment 16 with regard to the aggregated and cumulative exposure that also needs to be taken into account in the same ADI. As such a trigger value based on the ADI is not applicable if the active substance is used in different regulatory areas.
For all biocides, also thought may be given to derive an ARfD, as is done for plant protection products by EFSA, to cover acute effects of short term high exposure.
Point (22)See point 16. Furthermore, if it can be demonstrated that under normal conditions of use (i.e. those at the time of active substance authorisation) the use of biocidal products containing the active substance is not expected to lead to an exceedance of that part of the ADI, the MRL can be set at the default level of 0.01 mg/kg (or the LOQ of the analytical method, whichever is higher). When (default) MRLs are set, automatically routine monitoring by enforcement agencies will follow. It might be discussed whether a transitional period should be installed, where exceedance of MRLs in the start of the process of MRL-setting does not lead to immediate restrictive measures when there is no immediate danger for public health (see also points 37&38). This ensures that an MRL application will be done if future uses would result in an exceedance of this default level. Competent Authorities will be able to keep track of future developments.
Point (24)See German comment
Point (2526)Agreed. It is noted that currently within the FCM framework for the use of biocides, the FCM framework only indicates that approved biocides can be used. As such, the evaluation of the safety of the use of the biocides lies within the framework of biocides and should be dealt with accordingly within that framework.
Point (26&27)See German comment
Point (28)It should be stressed that an assessment is needed to decide whether the existing MRLs established in other frameworks still suffice with the additional use as biocide. In this respect it is noted that already enforcement encounters problems related to dual use, e.g. chlorate. Another example is amitraz found in honey, where in the 396/2005 the default is established, whereas within the veterinary framework a higher MRL is established. This subscribes to the need of a coordination group between the relevant frameworks to address these issues and establish a single MRL valid for all frameworks.
Point (29)Agreed.
Point (30)See German comment
In some cases tailor-made solutions may be required. This should not hamper the general principles that can be applied to most of the active substances.
Point (32)See German comment
Coordination between the different frameworks is urgently needed. For this a forum needs to be set.
Point (35&36)See German comment
Point (3738)See German comment
We acknowledge that it will be complex to establish specific MRLs as the biocidal products are not directly appliedon specific commodities, like in PPP and VMP framework. The use of biocidal products is also intentional andthe occurrence of residues is predictable in certain uses. Furthermore, the appreciable risk is not the principle we would welcome as the sole starting point for determining whether MRLs need to be set. We favour the setting of MRLs at a default level of 0.01 mg/kg for a transitional period. This transitional period could be used by industry to test for biocide residues in food and feed and by Member States to set up the required routine monitoring program. Data from industry and data from monitoring during this transitional period can indeed confirm the necessity to raise the default MRLs in the different PTs to a proper level that reflects good biocide use.
Point (40)See German comment
We do not agree that per definition, the contaminants framework is the suitable framework to be used to set a level for residues. Unlike contaminants, the use of biocidal products is intentional and follows specific use conditions, which can be controlled. As such the concomitant exposure is more in parallel with the pesticides (PPP), the veterinary (VMP) and the food additives (FA) framework, than it is with the contaminants framework. It is noted that other principles are applied in the contaminants framework than in PPP, VMP and FA.
Point (41)Agree that emphasis should be on the ALARA principle. This principle is not only applied in the contaminants framework, but also in the plant protection product framework.
Point (42,43,44)See German comments
Point (45)Why are the other related frameworks not included here? The MRL setting within the biocides framework connects all the frameworks which include assessing dietary risks. An overarching coordination group may be considered.
Appendix IDietary risk assessmentissues
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