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EUROPE – COM: Update of MRL setting procedure (SANTE/2015/10595 rev. 5.4)

The Commission published an update of Technical Guidelines SANTE/2015/10595 “MRL setting procedure in accordance with articles 6 to 11 of Regulation (EC) No 396/2005 and article 8 of Regulation (EC) No 1107/2009”.

The last version (rev. 4) was dated 2016.

In this new version 5.4, the following points have notably been developed:

  • Procedure when the residue definition or toxicological reference values are amended
  • Steps for new toxicological reference values for setting of import tolerances (i.e. case of substances for which no toxicological reference value was agreed upon at EU level)

and the following procedures have been added:

  • Fast-track procedure to set an MRL for a minor crop (on the basis of an extrapolation carried out from a major crop)
  • Withdrawal of MRL application (when no longer necessary or when not fulfilling the requirements)

 

To download: Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 5.4

 

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EUROPE: Publication of the supporting study for the ‘REFIT’ of Reg. (EC) No. 1107/2009 and No. 396/2005

The European Commission started in 2016 the application of the Regulatory Fitness and Performance programme (REFIT) to the European Regulation on pesticides (Regulation (EC) No. 1107/2009) and their residues (Regulation (EC) No. 396/2005). The aim of applying the REFIT programme is to assess if the current Regulations are ‘fit for purpose’ and meet the needs of citizens, businesses and public institutions in an efficient manner. In particular, the evaluation addresses synergies, gaps, inefficiencies and administrative burdens.

The main evaluation criteria set out to be addressed in relation to this REFIT Evaluation are:

  • Effectiveness of the intervention
  • Efficiency in relation to resources used
  • Relevance in relation to identified needs and problems
  • Coherence with other interventions with common objective
  • EU added value compared to what could have been achieved by EU country or international action.

The evaluation study, based on those criteria, which will support the REFIT evaluation was conducted between 2017 and 2018 by external contractors. The final report of the study was recently published (18 October 2018) and can be downloaded from the links below.

The analysis is based on data collected via case studies and consultation of stakeholders (EFSA, European Commission, Member State competent authorities, SME panel, etc.) and via an open public consultation which involved almost 10,000 citizens. The data analysis notably included timeline tracking and an analysis of the costs and benefits of the Regulations.

The main conclusions of the external evaluation study are:

  • The pesticide Regulation (EC) No. 1107/2009 led to an improved harmonisation of active substance and plant protection product (PPP) registration procedures in the EU, and it contributes to the protection of both human health and the environment. Nevertheless, important issues affecting the regulatory processes were identified. The lack of capacity and resources in MSs and at EFSA and the zonal system (in particular mutual recognition) not delivering as expected are among the key issues identified.
  • The MRL Regulation (EC) No. 396/2005 is generally effective in achieving its objectives. It ensures a high level of consumer protection and facilitates the functioning of the internal EU market. The main difficulties identified are related to the MRL revision procedure according to Art. 12, which is considered not ‘fit for purpose’. Besides, the current provisions for setting MRLs for non-chemical active substances are deemed inadequate.

The following issues were also underlined for both Regulations:

  • The delay for implementing and applying several provisions (e.g. assessment of the cumulative risk for consumers) creates obstacles to ensuring a high level of protection for both human health and the environment.
  • Active substances and PPPs not assessed in a timely manner often lead to unsatisfactory evaluations in light of the latest scientific and technical knowledge. The delays also lead to uncertainty and unpredictability which affect companies, particularly SMEs, in their capacity to innovate and to propose alternative solutions to replace hazardous substances.

The Commission REFIT evaluation, based on the results of this external evaluation study, is foreseen to be finalised in the first half of 2019.

 

To download:

Study supporting the REFIT Evaluation of the EU legislation on plant protection products and pesticides residues (Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005)

Executive summary

Final report

Annexe I : Synopsis report

Annexe II : Methodology and cost calculations

Annexe III : Consultation activities – surveys and interviews

 

Lynxee consulting’s team is at your disposal to answer your questions.

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EUROPE: Publication of the Technical Guidelines for Determining the Magnitude of Residues and Setting MRL in Honey

Endorsed at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF meeting) of 18-19 September 2018, the final version of technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels (MRL) in honey is now available (SANTE/11956/2016 rev. 9).

After some considerations on the residue definition for risk assessment and enforcement in honey, the guidance document provides a decision-making scheme as regards the type of experimental data required and MRL setting in honey. Other bee products (such as pollen, royal jelly, propolis, etc.) are excluded from the decision-making scheme as the consumption of these products by European consumers is considered negligible. Therefore there is no need to generate experimental residue data for such commodities.

The guidance states that the residue definition in honey should cover:

  • the components included in the residue definition in primary crops,
  • the degradations products formed during pasteurisation conditions, and
  • the components included in the residue definition in rotational crops (i.e. persistent compounds that can be taken up by plants from the soil).

The proposed decision-making scheme can be summarised as follow:

  • In case of no residues expected (e.g. application outside flowering and no persistence) or in case of low residue amounts in aerial crop parts, i.e. <0.05 mg/kg, the default MRL is set at 0.05 mg/kg (or at LOQ).
  • In case of residues in aerial crop parts ≥0.05 mg/kg and <0.5 mg/kg, the MRL is derived from the highest measured residue in aerial crop part.
  • In case of residue in aerial crop parts ≥0.5 mg/kg, complementary experimental studies (tunnel or field trials) are triggered to determine more realistic residue levels in honey. Studies can be conducted either with treated syrup (tunnel trials), to mime a worst-case transfer of residues from nectar to honey, or with treated attractive crops (tunnel or field trials).

For the first step, a list of the main agricultural crops in Europe which have melliferous capacity is included as appendix as a help for the determination if residues in honey are to be expected. For the latter steps, guidance on how to conduct the complementary experimental studies are included as appendices.

The technical guidelines will apply from 1 January 2020. Therefore, it will apply to all MRL review according to Article 12 of Reg. (EC) 396/2005 launched (i.e. EFSA data call-in) as from this date and to all applications at Member State level submitted by this date.

 

To download:

Technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels in honey – SANTE/11956/2016 rev. 9.

Summary Report of the Standing Committee on Plants, Animals, Food and Feed held in brussels on 18 September 2018 – 19 September 2018 – sante.ddg2.g.5(2018)5747771.

 

Lynxee consulting’s team is at your disposal to answer your questions.

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EUROPE – MRL: New Application form available

A new application form for MRL is available on Europa website.

It is to be used to:

  • Set specific maximum residue level(s) (new active substance not mentioned in Annex II/III/IV of Regulation (EC) No 396/2005);
  • Set specific maximum residue level(s) (changing current EU MRL listed in Annex II or III of Regulation (EC) No 396/2005);
  • Set import tolerance(s) (new active substance not mentioned in Annex II/III/IV of Regulation (EC) No 396/2005);
  • Set import tolerance(s) (changing current EU MRL listed in Annex II or III of Regulation (EC) No 396/2005);
  • Delete maximum residue level(s);
  • Include an active substance in Annex IV;
  • Amend existing residue definition;
  • Include active substance/product combinations into Annex VII as referred to in Article 18 (3) of Regulation (EC) No 396/2005;
  • Evaluate confirmatory data following review according to Article 12 of Regulation (EC) No 396/2005.

 

To download:

MRL Application form (SANCO 4044/2008 rev. 10.2) 16 June 2016

 

Lynxee consulting’s team is at your disposal to prepare your applications.

Contact us! http://lynxee.consulting/en/contact/