CA-July17-Doc.4.8(b)

23 June 2017

Background document for the discussion on “Iodine applications and residues monitoring in milk as a post-authorisation condition”

During the Human Health Working Group III in 2017, early discussions took place on Union authorisation applications for product families based on iodine/PVP-iodine (PT3).

One of the items for discussion was raised by UK and concerned the assessment of consumer exposure to residues and post-authorisation conditions(please see Annex I to this document). The WG members supported the UK proposal for post-authorisation data requirements. The draft minutes of the WG discussion are reported in Annex II to this document.

ECHA contacted the Commission services in order to check whether this suggested approach was consistent with the recent discussion in the 72nd CA meeting related to the MRL setting for iodine containing products.

The Commission services informed ECHA that: i) on account of the conclusion reached in the above-mentioned discussion (i.e.the current entry in the Commission Regulation (EU) No 37/2010 “No MRL required” should be sufficient for biocidal use); ii) the precedent that this decision might represent for other applications under national procedures; and iii) the consequences of such decision on other regulatory fields (e.g. veterinary medicinal products), this topic should be further discussed in the CA meeting.

Annex I

UK proposal on post authorisation data requirement:

Iodine PT3 biocidal products - draft data requirement for residues data

The levels of iodine in milk resulting from the use of “BIOCIDAL PRODUCT / BPF” are based on a theoretical extrapolation of data considered within the iodine PT3 CAR assessment / based on a theoretical calculation [delete / amend as appropriate]. In order to confirm the levels of iodine in milk resulting from the biocidal product uses, and therefore confirm the consumer exposure assessments, supervised residue trials to investigate the levels of iodine in milk following teat disinfection according to the critical (i.e. ‘worst case’ ) product use pattern(s) are required. Consideration may also be given to the generation of data to cover less critical use patterns in case the residue levels found lead to consumer intake concerns.

In the absence of guidance specific to biocidal products, the OECD Guidelines for the Testing of Chemicals - Residues in Livestock (OECD 505, adopted 8 January 2007) provides guidance on the conduct of supervised residue trials where there is a direct treatment of animals. Trials should include a minimum of 20 dairy cows with control groups (treated with a non-iodine based teat disinfectant) and treated groups (treated with the representative ‘worst case’ iodine-based teat disinfectant) investigated for a minimum of 28 days or until residues plateau in milk, if they have not done so within 28 days.Only the assessment of residues in milk is required, and data on residues in milk from dairy cows will usually equally apply to dairy goats.

Trials should be performed according to GLP, using a suitable analytical method for the determination of the resulting iodine levels in milk, validated in line with the ECHA “Guidance on the Biocidal Products Regulation Volume I: Identity/physico-chemical properties/analytical methodology – Part A: Information Requirements Version 1.1 November 2014”. Milk samples should be stored frozen (≤ -18°C) prior to analysis and, if not analysed within 30 days, storage stability data should be generated to provide sufficient evidence that there is no significant degradation of the residue of concern between sampling and analysis. Guidance on addressing the stability of residues on storage is outlined in the OECDGuideline for the Testing of Chemicals - Stability of Pesticide Residues in Stored Commodities (OECD 506, adopted 16 October 2007).

These data requirements have been discussed and agreed by MS at [EU WG / BPC meeting / etc] for the iodine PT3 biocidal products.

Annex II

Draft minutes of the Human Health WG-III-2017 discussion on assessment of consumer exposure to residues and post-authorisation data requirements:

Some of the preliminary assessments performed with theoretical calculations showed an unacceptable risk. In some cases, the background level of iodine in the diet would be higher than the reference values, especially for toddlers, regardless of the contribution of iodine from teat disinfection. It was highlighted that farmers would be exposed to higher iodine intake than general population because of the contribution from using iodine products in farming practise.

Post-authorisation data could be deemed necessary to protect consumers and to ensure that there would be no risk from teat disinfection with iodine products. With the current information, it cannot be excluded that the use of iodine in biocidal products would not pose health concerns.

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