HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL
Safety of the food chain
E.3 - Pesticides and Biocides
Note for discussion with Competent Authorities for Biocidal Products
This document is an attempt to provide guidance in the interest of consistency, and has been drafted by the Commission services responsible for biocidal products with the aim of finding an agreement with all or a majority of the Member States' Competent Authorities for biocidal products. Please note, however, that Member States are not legally obliged to follow the approach set out in this document, since only the Court of Justice of the European Union can give authoritative interpretations on the contents of Union law.
Subject:Developing a policy approach for the establishment of maximum residue levels for residues of active substances contained in biocidal products
1.-Background and purpose of the document
(1)As the use of biocidal products may lead to residues in food or feed, Article 19(1)(e) of Regulation (EU) No 528/2012[1] (BPR) lays down that, where appropriate (emphasis added), maximum residue levels (MRLs) for food and feed have been established in accordance with relevant Union legislation.
(2)In September 2009, a note[2] on the establishment of MRLs was endorsed.
(3)In July 2013, the Commission presented a discussion note[3] on the use of biocides in food contact materials. The Commission suggested that only for those substances that are deliberately incorporated or impregnated into the final food contact material to achieve a biocidal function and keep the article free from microbial contamination, which are also likely to migrate into food ('surface biocides'), a limit for residues should be set. The Commission indicated that the details of the procedure to coordinate the assessment of application for product authorisationunder the BPR and the setting of MRLs also had to be discussed.
(4)In December 2013, the Commission presented a discussion note[4] on the general approach for MRL setting for biocidal active substances. It was suggested in this note, in order to use the limited resources in an efficient way, to develop a focused and risk-based approach to identify active substances requiring MRL setting based on proven concerns for consumers.
(5)In March 2014, the Federal Institute for Risk Assessment in Germany (BfR) together with the Commission organised the Conference on MRL Setting for biocides[5]. During that Conference, the Commission identified a number of open questions with regard to the establishment of MRLs such as the extent of carry-over of biocides into food and feed, the identification of critical areas with implications forconsumer safety, the enforcement of MRLs and procedural aspects.
(6)In January 2015 the Committee for Medicinal Products for Veterinary Use of the European Medicines Agency (EMA) adopted a Guideline on risk characterisation and assessment of MRLs for biocides[6].
(7)In parallel to this, draft guidance documents have been developed by theAd hoc WG on the Assessment of Residue Transfer to Food (ARTFood):
- on Estimating Livestock Exposure,
- on Estimating Transfer of biocidal Active Substances into Foods-Professional Uses, and
- on Estimating Transfer of biocidal Active Substances into Foods- Non-Professional Uses.
(8)The purpose of this document is to discuss the way forward. In particular, a procedure is discussed to decide whether a limit for a residue of a substance contained in a biocidal product is required and how such a limit would be established. Based on this discussion,details of the procedure can be further developed.
2.- Suggested way forward
(9)A step-wise procedure is proposedto decide in which situationsand/or under which conditions it is necessaryto establish limits for residues of active substances contained in biocidal products.
(10)For that purpose it is essential to clarify the responsibilities of the different actors (applicants, EU Agencies, Member States Competent Authorities and the Commission) in this process.
(11)One of the purposes of the BPR is ensuring a high level of protection of human health and animal health. Therefore key points in the procedure should be the use pattern of biocidal products on the market, the likelihood for transfer into food and feed, to what extent exposure of consumersto residues of these substances will actually occur as well as the risk associated with this exposure.
(12)Biocidal products are not intentionally added to food or feed.
(13)The use of biocidal products, during the production, manufacture, processing, preparation, treatment, packing, transport of animals, plants, food or feed, may however lead to the presence of residues in food or feed.
(14)The consequence of the way biocidal products are used is that residues are more likely to be found in processed or composite food rather than in unprocessed food.
(15)Therefore a specific approach for biocides is needed.
Consumer exposure unlikely and/or no appreciable risk: no further action
(16)The question of residues should only be further explored, when active substances under normal conditions of use (i.e. the conditions of authorisation of the biocidal products)can lead to a potential consumer risk.
(17)For the following substances it could be assumed that there is no potential consumer riskbecause no transfer to food or feed can be expected or the presence in food or feed is unlikely to involve a risk:
(a)substances included in the EU list of approved food additives[7],substances used as feed additives[8], or substances normally used as food and/or feed and listed as a food or feed item in Annex I of Regulation (EC) No 396/2005[9]
(b)substances included in Annex I to BPR[10] or Annex IV[11] of Regulation (EC) No 1907/2006 and Annex IV of 396/2005[12],
(c)substances in biocidal products belonging to the product groups PT1, PT2, PT6, PT7, PT9, PT10, PT11, PT13, PT14, PT15, PT17, PT20 and PT22 .
(d)micro-organisms approved under Regulation (EC) 1107/2009 or under the BPR, when it is concluded in the assessment report that the organism is sufficiently well defined to establish it has no toxicity or infectivity to humans, and that it does not produce/contain any toxin that could adversely affect consumer health[13].
(e)consumer exposure to the active substance linked to use as a biocidal product is considered as negligible compared to other uses in the food chain and/or natural background[14].
(18)A potential consumer risk should be determined by a realistic animal external exposure assessment and/or consumer exposure assessment. This exposure could be refined depending on the availability of supplementary data and/or the inclusion of risk mitigation measures for the use of the biocidal product.
(19)In the area of plant protection products, the European Food Safety Authority (EFSA) decides whether to further investigate residues and initiate the process of MRL setting for products of animal originbased on the residue contentin animal feed, which in turn determines the animal's exposure to the residue. The threshold value used by EFSA is of 0.1 mg of residue per kg of feed dry matter, however other factors such as fat solubility and the uncertainty of the dietary burden calculation are also taken into account for the decision. This EFSA trigger value was extrapolatedto a trigger value of 0.004 mg/kg body weight of the animal (4 µg/kg bw) for the external exposure of a food producing animal to a biocidal active substance[15]. Use of biocidal products leading to an animal exposure below this trigger value can, in most cases[16], therefore be considered as involving no appreciable risk and would therefore not require the establishment of a limitin food of animal origin for the active substances they contain.
(20)The Acceptable Daily Intake (ADI) of a substance is an estimate of the residue, expressed in terms of micrograms or milligrams per kilogram of bodyweight, that can be ingested daily over a lifetime without any appreciable health risk.
(21)In order to further ensure consumer safety the threshold for triggering the establishment of a limit for residues could be based on a certain part of the ADI[17].
(22)There would then be no need to establish a limit if it can be demonstrated that under normal conditions of use (i.e. those of the authorisations) the use of biocidal products containing the active substance is not expected to lead to an exceedance of that part of the ADI.
(23)This is an approach that needsto be discussed.
Likely consumer exposure with appreciable risk
(24)Ifconsumer exposure is likely to occur with an appreciable risk, the following approach is proposed.
Active substances used as surface biocides in food contact material: the FCM approach
(25)Regulation (EC) No 1935/2004 on food contact materials (FCM) provides the possibility to adopt specific measures that include limits on the migration of constituents into or on to food. Risk assessment is performed by the European Food Safety Authority (EFSA).
(26)For biocidal products to be used as FCMs a measure will be developed to establish limits for active substances contained in those biocidal products. Further discussion is required on the details of the procedure to establish a specific migration limit.
Active substances used in animal husbandry: the VMP approach
(27)For biocidal products used in animal husbandry and for which an MRL evaluation is considered necessary for the active substance, Article 10 of Regulation (EU) No 470/2009 specifies that a limit shall be established through this regulation. The risk assessment is performed by the EMA. The data requirements for the applications are included in the EMA Guideline on risk characterisation and assessment of MRLs for biocides[18]. Further discussion is required with EMA on the level of the fee applicable and procedures to establish a limit.
Active substances used for other purposes
Case where specific limits are already established:
(28)Substances contained in biocidal products may alsobe used as feed additives, VMPs or PPPs. When MRLs have already been established or are applicable, whether specific or default, they should be used.
(29)In that respect, for active substances currently or formerly used as PPPs, the 0.01 mg/kg default limit established by Regulation (EC) No 396/2005[19] would apply in the absence of more specific MRLs.
(30)However, recent developments have demonstrated the difficulty to comply with this default value in some cases, especially for residues of certain biocides that are no longer used as PPPs in processed or composite food products, e.g. in case of quaternary ammonium compounds[20].
(31)This is a matter that needs to be discussed.
(32)Furthermore, where different MRLs have been established for a substance, it is not clear what limit should be used.
(33)This is a matter that needs to be discussed.
(34)Those limits will however have been set in most cases for specific food commodities (for example meat, milk or apples), whilst residues from biocidal products are mainly expected to be detected and of relevance in processed or composite food products.
(35)Furthermore, depending on the characteristics of the process or mixing involved, the residue level in the final food product may increase or decrease (for example as a result of a drying or diluting process).
(36)Therefore, in accordance with current practices,controls of processed and composite products should be based on the established limit for non-processed food,but taking into account changes in residues caused by processing and/or mixing (as provided for by Article 20 of Regulation (EC) No 396/2005 and Article 2 of Commission Regulation (EC) No 1881/2006).
Case where specific limits are not yet established:
(37)Considering again that biocidal products are not intentionally added to food or feed and that it might be extremely complex to start establishing specific MRLs, when the dietary risk assessment leads to the conclusion that consumer exposure with an appreciable riskis likely, it is suggested that, occurrence data should be collected by way of monitoring before confirming that it is necessary to establish MRLs.
(38)The purpose of this monitoring would be to confirmthe presence of the residues of the substance in food or feed,to identify the sources of these residues and to help decide whether it is necessary to establish a limit and, if so, the appropriate legal framework.
(39)This is an approach that needs to be discussed.
(40)Council Regulation (EEC) No 315/93 (contaminants) or Directive 2002/32/EC (undesirable substances in feed) could then be used to set a level for residues.
(41)It is emphasised that limits adopted by Council Regulation (EEC) No 315/93 and Directive 2002/32/EC will be set, based on the available information, as low as reasonably achievable.
Final considerations
(42)The timeline for concluding the procedure forestablishing MRLs for active substances contained in biocidal products will depend on the available information and under which legal framework it will take place.
(43)The process of establishing MRLs should take place between the substance approval and the product authorisation.
(44)In cases where it would not be possible to complete the process by the time of product authorisation, in accordance with Article 22 of the BPR, it may be necessary to include, in the product authorisation a condition that data need to be submitted for the establishment of an MRL or to allow a certain time for the monitoring of residues in order to establish whether it is appropriate to establish a maximum residue limit.
(45)It may also be necessary to amend primary legislation and establish or amend secondary legislation as referred to in Article 19 of the BPR. An evaluation of Regulation (EC) No 1107/ 2009 and Regulation (EC) No 396/2005is foreseen. In this context the Commission may consider proposing amendments to better address the case of active substances used in biocidal products.
(46)Finally, it should be noted that Council Regulation (EEC) No 315/93, Directive 2002/32/EC, Regulation (EC) No 1935/2004 and Regulation (EC) No 470/2009 do not provide specific rules on data protection and data-sharing.
3.- Action requested
(47)The Commission services invite the CA meeting to discuss the proposed way forward outlined in this paper.
1
[1]Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products
[2] Reference:
[3]Reference:
[4]Reference:
[5] The minutes of the BfR conference on MRL setting are available at:
[6]The relevant EMA-documents are available at:
[7]Regulation (EC) No 1333/2008 on food additives.
[8]Regulation (EC) No 1831/2003 on additives for use in animal nutrition.
[9]This approach is in line with Guidance document on criteria for the inclusion of active substances into Annex IV of Regulation (EC) No 396/2005 (SANCO/11188/2013, 13 June 2013), reference:
[10]Active substances contained in the biocidal product eligible for the simplified authorisation procedure (Article 25(a) of BPR).
[11]Substances that are considered to cause minimum risk because of their intrinsic properties (Article 2(7)(a) of REACH)
[12]Active substances of plant protection products for which no MRLs are required (Article 5 of Regulation (EC) No 396/2005).
[13]See footnote 9.
[14]See footnote 9.
[15]The method by which this threshold was established is shown in Annex I of Guideline on risk characterisation and assessment of MRLs for biocides, for reference seefootnote 6.
[16]The CVMP guideline highlights that if the substance presents a particular concern (e.g. it is particularly toxic or is likely to accumulate), then an MRL evaluation may be needed even if the trigger is not exceeded.
[17]See for instance the guideline on risk characterisation and assessment of MRLs for biocides of EMA, which set that threshold at 30% of the ADI, for reference see footnote 6.
[18]See footnote 3.
[19]Article 18(1) of Regulation (EC) No 396/2005 specifies that the products covered by Annex I shall not contain, from the time they are placed on the market as food or feed, or fed to animals, any pesticide residue exceeding […] 0,01 mg/kg for those products for which no MRL is set out in Annexes II or III, or for active substances not listed in Annex IV unless different default values are fixed for an active substance in accordance […].
[20]See Commission Regulation (EU) No 1119/2014 of 16 October 2014 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benzalkonium chloride and didecyldimethylammonium chloride in or on certain products