Manna Regulatory

06/04/2022

This last article of the series “Guidance on plant protection product authorisation deals with costs and timelines of the steps from the development of an active substance until a plant protection product containing this active substance is authorised in a Member State in the EU.
Check out the other articles of the series or the series on “Guidance on active substance approval”. A new series “Guidance on dossier content – active substance and product” is planned and the publishing will start
During 2022.

23/03/2022

We are almost at the end of this article series with article 29 on ideas to authorisation. The article provides insight into the complexity of the development process from idea to authorisation.

It is a long, difficult, and expensive journey to develop a new active substance and its plant protection products. This article provides an idea of the complexity of the development process, the strategies and the number of tests involved.

09/03/2022

Article 28 of this series of articles deals with Integrated Pest Management. It is founded in Directive 2009/128/EC, but Integrated Pest Management does also have an impact on plant protection products. Therefore, it is important to mention it in this article series. Integrated Pest Management was also mentioned in the series “Guidance to active substance approval” where article 26 dealt with the National Action Plans.

Integrated Pest Management must be mentioned when discussing the authorisation of plant protection products. This article is related to article no.

02/02/2022

Emergency authorisations are a tool used to quickly help farmers in urgent need of a plant protection product controlling a specific pest. Such authorisation have a limited lifetime and this article gives you the details of it works and when it can be achieved.

Emergency authorisations are not something the applicant can use strategically, but these kinds of authorisations are helpful for the farmer in urgent need of a plant protection product to control a specific pest. Article 53 of Regulation (EC) 1107/2009 provides for the Member States to authorise,

19/01/2022

When an authorisation of a plant protection product is granted, it is still possible for the applicant to change the authorisation. This can be good to know before initiating the authorisation process because the applicant can start with a simpler case to get the product authorised and then add more complex situations afterwards or add additional uses of which the data was not ready at the time of submission. This article explores some of the possibilities an applicant have after the authorisation of a plant protection product in the EU.

05/01/2022

Happy New Year! A short article on other options than the zonal system when an applicant applies for authorisation of a plant protection product in a Member State in the EU.

15/12/2021

The 23rd article of the series “Guidance on plant protection product authorisation” provides information on MRLs outside Europe. The setting of MRLs are not harmonised worldwide and you will find several other countries or organisations that establish MRLs that applies in their country.

EU is not the only institution to fix MRLs. The Codex Alimentarius Commission and the US set MRLs too.

01/12/2021

Farmers, traders and importers must comply with MRLs because they are responsible for food safety. National authorities in the EU control and enforce MRLs by taking samples and checking pesticides levels. This article gives an overview on how to comply with MRLs.

Farmers, traders and importers must comply with MRLs because they are responsible for food safety. National authorities in the EU control and enforce MRLs by taking samples and checking pesticides levels.

17/11/2021

This 21st article of the series “Guidance on plant protection product authorisation” is about the assessment of cumulative and synergistic effects of compounds. This is related to MRL settings and is a rather new assessment strategy agreed on in the SCoPAFF in September 2018. The article tries to give an idea of the retrospective scenario used in the assessment.

The assessment of cumulative and synergistic effects of compounds is done through a retrospective scenario of two steps. In step 1, cumulative assessment groups are established and characterised.

03/11/2021

An application for an MRL can be submitted and evaluated alongside an application for authorisation of a plant protection product. The process consists of 9 steps and these steps will be discussed in this 20th article of the series “Guidance on plant protection product authorisation”.

It is possible to apply for a new MRL alongside the application of a plant protection product. The MRL can also be modified at a later stage or it can be applied as an import tolerance on request from a third country.

25/10/2021

The residue definition is defined through 3 modules and a series of steps. This 19th article of the series “Guidance on plant protection product authorisation” is exploring how this is done.
Feel free to take a look at the first 18 articles and please share, comment or ask questions if you find it interesting.

The residue definition is defined through 3 modules and consists of a series of steps. Some of the steps have two outcomes: One that leads the metabolites further down the steps and one that rules the metabolite or metabolites out of the residue definition.

07/10/2021

The setting of MRLs are based on two principles: The MRL must be as low as possible and foodstuff must be safe to the consumers. This article explores the background for setting the MRLs and article 19 will go into detail about how the residue definition is defined.

Maximum residue levels are set based on supervised trials and the procedure of setting an MRL is based on two principles. The MRL must be as low as possible and foodstuff must be safe to the consumers.