Normativa UEAbr. 23, 2012
UE: autoridad alimentaria revisa límites máximos de residuos para daminozide
Daminozide was included in Annex I to Directive 91/414/EEC on 01 March 2006, which is before the entry into force of Regulation (EC) No 396/2005 on 02 September 2008. EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(2) of afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked The Netherlands, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile).
Considering that daminozide is only registered for use on non-consumable crops within the European Union (flowers and ornementals) and that no import tolerances were notified by the designated rapporteur Member State, the completion of the PROFile was not deemed necessary. EFSA based its assessment mainly on the conclusions derived by The Netherlands in the framework of Directive 91/414/EEC.
On 16 January 2012 EFSA issued a draft reasoned opinion that was circulated to Member State experts for consultation. No comments were received by 16 March 2012 and the following conclusions are derived.
The toxicological profile of daminozide was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.45 mg/kg bw/d. An ARfD was not deemed necessary.
Considering that the use of daminozide is restricted to non-consumable crops within the European Union, that no CXLs are available for this active substance and that no uses authorised in third countries were notified to the RMS, residues of daminozide are not expected to occur in any plant commodity and in any animal product. Since primary crop and livestock metabolism of daminozide were not investigated, EFSA was not able to propose relevant residue for enforcement of a potential illegal use. However, there are indications that daminozide is metabolised into 1,1-dimethyl-hydrazine (UDMH) in plants. It might therefore be relevant to analyse this compound as well as the parent compound for enforcement of a potential illegal use.
No validated analytical methods for enforcement of daminozide or UDMH in commodities of plant and animal origin are reported.
A risk assessment is in principle not required considering daminozide is only registered for use on non-consumable crops but, the LOQs currently established by Regulation (EC) No 396/2005 provide a satisfactory level of protection for the European consumer. The same applies when considering default MRL of 0.01 mg/kg for all commodities.
Considering that the enforcement of potential illegal uses falls under the remit of risk managers, EFSA is not in a position to recommend whether the default MRL of 0.01 mg/kg, as defined by regulation (EC) No 396/2005, should apply or whether the setting of a specific LOQ is necessary. As there are indications that daminozide decomposes to 1,1-dimethyl-hydrazine, it might be relevant to analyse this compound as well as the parent compound for enforcement of a potential illegal use. Although the specific LOQs currently established in the above regulation provide a satisfactory level of consumer protection, it is known whether these LOQs can be achieved through routine enforcement.