European Fertilising Products Regulation vs “Mutual recognition”

Fertiliser registration in Europe is changing, and all of us in this sector know that the new Regulation EU 2019/1009 will bring about major changes in the sector.

Just to cite one, biostimulants are finally regulated. On the one hand, the law will allow for a unique registration applicable in all the EU Member States (27), simplifying the multiple arrangements that currently have to be made when registering them in the different local legal systems. But at what cost and with what studies can they be registered within the different groups of the new regulation?

Today there is no answer to these questions, so companies can wait until the working guidelines of the new implementation regulation are issued before June 2022, if there are no delays, or they can proactively take advantage of this time and generate sales registrations.

How?

“By taking advantage of the “Mutual Recognition” that opened in the majority of European countries”

By taking advantage of the “Mutual Recognition” window that opened in the majority of European countries in 2020 as a result of multiple rulings by the Court of Justice of the European Union.

In April 2020, this new Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on mutual recognition of goods lawfully marketed in another Member State entered into force, repealing Regulation (EC) 764/2008. This regulation stipulates that Member States shall facilitate cooperation and the exchange of information within the context of the principle of “Mutual Recognition”. Several European countries are already applying this regulation to authorise the sale of fertilising products that are already authorised and being sold in another EU country.

Currently, the process takes 2-5 months, depending on the country, with different fees and documentation to be submitted.

We all know that once a product is registered, if a new law enters into force, we may be asked for additional documentation, but this documentation is unlikely to differ from what we have to submit to the registrations currently in force in the local country. Therefore, we have registrations and we sell in those countries where we have requested “Mutual Recognition” as we await a possible revision, far ahead of those who have decided to await the new European guidelines.

“we have to take advantage of the current situation to access these markets”

We have regulated fertilisers in Europe for many years now, and we all know that there are countries with complicated laws that are difficult to access because of the heavy investment needed, so we have to take advantage of the current situation to access these markets.

At SUN CHEMICALS SERVICES, we take care of everything you need and offer you the support you require in the prior processes of strategic and regulation consulting. We evaluate your products in relation to their potential compliance with the laws and the possibility of registering them in both the EU and the Americas.

Europe

– We help you understand and fulfil the new European Regulation EU 2019/1009.

– We help you with the “Mutual Recognition” paperwork according to Regulation EU 2019/515 in almost all European countries.

– We check compliance and undertake the registration process in accordance with Royal Decree 506/2013 (Spain).

– We identify and advise on selling “EC fertiliser” products according to regulation (EC) 2003/2003 (which is scheduled for repeal in June 2022).

United States and Latin American countries

– We guide you in the registration process in accordance with the laws in force in each country or state by making a prior analysis of the requirements and costs. – Manufacturer Company Registration.

– Preparation of the registration file for organic and inorganic products.

– Conducting, coordinating and monitoring specific studies from each country.

– Contracting and tracking efficacy studies.