EUROPE – EFSA: Guidance on risk assessments for substances, impurities and transformation products that may have stereoisomers

EFSA has published a guidance on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities. The document also proposes guidance to be used for active substances that, without containing any stereogenic element, may generate transformation products or metabolites  that do contain them. As a general principle, stereoisomers need to be treated as different chemical components for the risk assessment.

The draft version was proposed to public consultation in April – May 2019. A report presenting the  comments received and how they have been considered by EFSA has been made available.

In this guidance, Regulation (EU) 283/2013 on the data requirements for the plant protection active  substances is analysed, and recommendations are given on how to best address and assess the data requirements for active substances containing stereoisomers. Furthermore, the guidance gives recommendations on how to make the best  use of the available information to perform the risk assessment of these substances, particularly in situations when the information on individual isomers is not available or difficult to obtain, with the primary objective to reduce the need to repeat vertebrate animal testing.

One special situation is when active substances, that without containing any stereogenic element, may generate transformation products that do contain them. In these cases, it is appropriate to refer to metabolites containing stereoisomers. For these substances, the guidance should not be applied to the active substance but should be applied to assess metabolites that contain a stereogenic element.

 

To download: 

Guidance of EFSA on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers

 

Outcome of the public consultation on the draft guidance on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers

 

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

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

EUROPE – COM: Technical Guidelines on Data Protection

These technical Guidelines are intended to help Member States and Applicants for practical application of the legal provisions of Articles 59 – 62 and 80 of Regulation (EC) No 1107/2009. This Commission Notice replaces SANCO/12576/2012– rev. 1.1, 01.02.2013. The use of these revised Guidelines is recommended for any applications for active substance and/or plant protection products submitted after 3 October 2019.

This document covers 2 main areas:

  • Section 1 – explaining the periods of protection applied to studies under different circumstances – the “why, when and how long”
  • Section 2 – clarification of the special procedures and provisions that apply to vertebrate data sharing

The following parts have been revised compared to the first version of the document dating from 1 February 2013:

  • Change to provisions for protection of confirmatory data.
  • Clarification of general requirements for applying protection via increased emphasis of paragraph 6.
  • Clarification of other points of the technical Guidelines which were raised by Member States, thanks to their gained experience and while developing other guidelines, such as the one on Article 43 of Regulation (EC) No 1107/2009.
  • Change of rules for the acceptance of duplicate studies.

 

To download: 

COMMISSION NOTICE Technical Guidelines on Data Protection according to Regulation (EC) No 1107/2009 (08.07.2019)

 

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

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

 

FRANCE: Experimental use of pilotless aircrafts for pesticides spraying

The agriculture and food law, also called EGalim law authorises the experimental use of pilotless aircrafts, for a 3-year period (October 2018 – October 2021), for aerial spraying of plant protection products authorised in organic farming or within in certified farms, authorised for aerial spraying,and limited to crop areas with a slope equal to or higher than 30% (article 82).

This experiment aims at assessing the benefits of the use of pilotless aircrafts for the limitation of work-related accident  and for the application of pesticides.

It should be implemented in accordance with the French regulation as regards pilotless aircrafts, in particular Orders dated 18 May 2018 and 17 December 2015.

The EGAlim law sets that the experiment should be assessed by Anses. The law also sets that the conditions and modalities of this experiment should be defined by a joint order signed by the ministers of environment, agriculture and health, to ensure that there is no unacceptable risk for the Health and for the Environment.

 

The draft Order was proposed for public consultation from 26 June to 17 July 2019. The public comments (in French), the synthesis of the consultation (in French) and the reasons for decision (in French) have just been published.

 

At the same time, after being seized on 23 May 2019 by the Managing Director for food, the Managing Director for Health and the Managing Director for the prevention of risks, Anses has published a scientific and technical support note as regards « the implementation of experimental use of pilotless aircrafts for plant protection products spraying » (in French).

In this note, Anses indicates which guidelines should be considered and also which key data should be collected so that the experiment could achieve its goals:

A – Work-related accident Risk assessment when using pilotless aircrafts for spraying.

B – Operator and other actors exposure assessment during the mixing, loading, spraying and cleaning phases.

C – Spray drift assessment with the material used and assessment of the environmental exposure.

D – Other relevant criteria in the framework of the experiment and its goals, such as spray quality and efficacy.

 

References :

Public consultation: Draft Order as regards the implementation of experimental use of pilotless aircrafts for pesticide spraying (in French)

 

Order of 18 May 2018 as regards the requirements applicable to pilots using pilotless aircrafts for purposes other than leisure (in French)

Order of 17 December 2015 as regards the use of airspace by pilotless aircrafts (in French)

Order of 17 December 2015 as regards the pilotless aircarft design, conditions of use and abilities of people who use them (in French)

 

Our previous articles:

FRANCE: New Agriculture and Food law published

 

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

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

FRANCE: A road map about the reduction of use of copper in agriculture

A roadmap for the reduction of use of copper in agriculture was issued by the French Ministry of Agriculture on 15 July in order to better coordinate actions and to ensure their coherence. It has been drafted by a working group involving the competent administrations and research and development actors. The main directions were presented during the Strategic Orientation Committee (COS) of the Ecophyto Plan on 10 April 2019.

The document recalls that the European Commission renewed the approval of copper on 27 November 2018 for a period of 7 years but restricted the use to applied amounts of 4 kg per hectare per year on average, giving the opportunity to the Member States to allow the application of a maximum application rate of 28 kg/ha over 7 years.

It is indicated that in France, ANSES will assess applications for the renewal of the approval of copper-based PPPs, taking into account the “maximum 28 kg/ha for 7 years” option, providing that the conditions of use are properly detailed in the applications and that data support the intended uses.

The roadmap also refers to the scientific opinion “Can we do without copper in organic farming?” published in January 2018 by INRA (French National Institute for Research in Agriculture), which provides a comprehensive and scientifically based overview of the uses and alternatives to copper available to farmers.

Finally, this document specifies that the copper dose reduction efforts should be strengthened, following 5 directions with short-term, middle term and long-term actions:

  • Promotion of research, innovation and acquisition of knowledge on pathogens, impact of copper use, dose reduction and development of alternatives
  • Information and favoring good practice and use of already existing alternatives to copper
  • Adaptation of the regulation in order to favor the development of alternatives
  • Help and training of farmers to the change of practices
  • Cooperation with Europe, especially Germany, which is already engaged in a copper reduction of use process

 

To download: 

Road map for the reduction of use of copper in agriculture (in French)

 

See also our previous articles: 

EUROPE: Copper compounds renewal for 7 years

 

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

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

OECD: A step-wise approach for the verification process of the GLP Status of Non-Clinical Safety Studies

The OECD recently published, in the series on principles of Good Laboratory Practice (GLP) and compliance monitoring, a guidance document for receiving authorities on the review of the GLP status of non-Clinical safety studies (document 20).

This guidance does not address the scientific evaluation and interpretation of the submitted data or the risk assessment based on these data.

Indeed, this guidance promotes an adequate and time-efficient evaluation of the GLP status of nonclinical safety data, offering a step-wise approach of the GLP verification process.

If there is doubt on the GLP status of the data, the assessor should consult the relevant national GLP Monitoring Authority to discuss the impact and potential consequences of any GLP-related issues identified during the evaluation process before accepting GLP claims on the submitted data or requesting a GLP inspection and/or study audit.

 

To download: 

OECD Document 20 (ENV/JM/MONO(2019)25) Guidance Document for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies

 

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

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