Thank you for your interest.

Please consider to chanel your query as appropriate to EFSA via

http://www.efsa.europa.eu/en/aboutefsa/contact

Public enquiries: If you have a question about EFSA, please use the Ask EFSA service

Thanks Renata. I will do it.

However, it is also useful to know the opinion of the people that work in the pesticide area, based on their expert knowledge.

Best regards,

roberto

Thanks a lot for the useful links.

And please, could you also give your contribution for the three questions?

The approach by country is a dysfunctional system recognized by all stakeholders including the regulators. That is why the OECD and all member countries have developed a harmonized process and tools. This way, one can produce one submission package for all countries. One can then ask for work share between regulators enabling a better use of the limited regulatory resources. This is the only way forward if our intention is to feed the world (SDGs come to mind). The OECD does not train growers, regulators, or plant health products companies to use these tools as it is not their mandate. This training is available here: www.idrg.eu. The tools are available for free on the OECD website.

Thanks, Jacques for your contribution.

And, could you please provide details about your statement “The approach by country is a dysfunctional system recognized by all stakeholders including the regulators”? E.g. links to papers or giving your contribution also to the three specific questions.

Dear Roberto,

There is a lot of literature when looking for global joint review, and workshares. The EU is in itself harmonized to a certain degree for the A.S. and one product. The rest is country specific but the format of the submission is the same for all EU countries. That is good but by very far not enough. Here is the link to the OECD page: https://www.oecd.org/env/ehs/pesticides-biocides/oecdguidancedocumentsforpesticideregistration.htm

Finally the questions:

1) How is the procedure in your country: one or more levels? Please, give explanation and references.

We work in all countries of the world . In North America there is the NAFTA Joint review,. In the EU the A.S. evaluation is EFSA's role and the product and uses are by zone with one member state representative. In Africa there are several country sharing scheme like INSAH for ECOWAS and WAEMU but listing all these goes beyond this context.

2) Do you think that only one central procedure can ensure to speed up and harmonize the decisions? Please, give pros & cons. Harmonization is the only way to have sustainable agriculture and trade, reach the SDGs, address food safety, and give back to agriculture its economic motor role but arguing this here is not possible. We have several documents that involve FAO, STDF, etc but it is a lifetime subject in itself. One thing is sure, eye-level on a level playing field is only possible if we harmonize. The economy of scale, the increase in quality and safety and the access to all growers to all the tool they need is a sine qua non for food safety worldwide.

3) Do you think that each country should have a legislation more harmonized for pesticide (and food/feed residues) with the Codex Alimentarius? Please, give pros & cons.

I think harmonization is the only ethical path forward but not with Codex. First Codex covers a very very small use proportion, takes much too long to be published, and has been created for a purpose that does not serve global harmonization, at least for now. There is a MRL harmonisation work under way led by the Minor Use foundation. But a comprehensive answer can't be put into a research gate answer :-)

You know how to contact us.

Jacques

Dear Jacques,

Thank you very much for your useful contribution.

roberto

You are very welcome Roberto. I wish I could speak Italian but can't to the sadness of my in-laws :-)

Dear colleagues,

In my experience, this system of authorization and evaluation of active substances and phytosanitary products that entered into force in 2001 and that is established by Regulation 1107/2009, is a harmonized system among all the countries of the European Union.

Active substances are approved at the European Union level. Plant protection products are then authorized at the Member State (MS) level, but that MS belongs to one of the three regulatory zones in the European Union, thereby facilitating the mutual recognition of authorizations for plant protection products between Member States of the same zone, there are even exceptions in which it can be authorized in another MS from another regulatory zone.

It is a process that should be more agile than the previous Directive 91/414. The problem comes when national requirements for the authorization of a plant protection product arise, since each MS has its peculiarities and a different agriculture from that of its neighbor. It is here where the effort to present quality dossiers by the applicants is essential. These biological and chemical data packages must cover all the requirements established in Regulation 284/2013 and also if there is any national requirement for an MS, for example, testing on a variety of grapes.

Roberto Molteni

check this paper, although is in Spanish.

Article Requisitos de datos de eficacia y principios para su evaluac...

Thanks. It is nice to read you after long time.

The Regulation 1107/2009 has been an effort to harmonize the system among all the countries of the European Union.

However, some grey zones still remain and I have tried to highlight them in the three questions for discussion.

For example, it is true that each MS has its peculiarities and different agricultures; however, it is also true that INSIDE each MS, there are peculiarities and a different agriculture and this is not an obstacle to have a unique national level. For example, in Spain there is only a national authorization and not several Autonomous communities authorizations, although they have very different climatic and agricultural condition (e.g. Galicia and Andalusia).

This means that it would be possible manage all the peculiarities and different agricultures at higher levels, with better harmonization and faster procedures.

Other question is the full harmonization of pesticide (and food/feed residues), for example with the Codex Alimentarius or other approaches, avoiding trade disputes.

There are rooms for many discussions, as also Jacques Drolet pointed out.

Indeed. The Regulation 1107/2009. Each Member State can decide if Authorise the PPP or ban it.

Thanks for your contribution.

It would be also valuable your contribution on the three questions. It is useful the personal thinking of the people involved in the pesticide area.

Dear prof Hanna-Andrea Rother ,

Thank you for the contribution.

Health and environmental issues should be a priority for all countries.

In our global world, we should keep in mind that import goods have a responsibility and should be not only safe for European people but also produced in a safe environment.

Unluckily, for the imported goods the concept of safe environment is not included in the “import tolerance” (Article 3 1. (g) Regulation (EC) No 396/2005 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02005R0396-20200518 )