Protection & nutrition

Protection & nutrition Biostimulants

RRA provides you with the support you need to market your biostimulant products in all European Union countries. Currently, biostimulant products are regulated by the national legislation of each member state.

The new Regulation (EU) 2019/1009 will come into force as of July 2022. The two systems (national and European) will then prevail and coexist.

RRA can assist you in preparing your national application files and mutual recognition. It can also help you prepare files under Regulation (EU) 2019/1009.

Our offer

Strategic analysis of your biostimulant for effective placing on the market

Depending on the target countries, a case analysis can be conducted on the basis of the composition of your product and its claims in order to establish the most appropriate regulatory approach.

Stewardship (preparation and participation) for pre-application meetings

Drafting of the technical file and administrative documents

Monitoring of laboratory analyses

Assistance in setting up efficacy trials

Submission of the registration dossier to relevant authorities

Efficient monitoring of the evaluation process and interactions with relevant authorities

RRA is a member of the Technical Committee 455, in charge of biostimulants, of the European Committee for Standardisation (CEN). The purpose of this committee is to provide new harmonised standards to implement the new Regulation (EU) No 2019/1009.

Hence, our team is working at the very core of the development process of standards and this allows us to offer you the best strategic support within the framework of this new Regulation (EU) No 2019/1009.

Contact

RRA Redebel Regulatory Affairs

Newsletter

REGISTER

Top On Web

Ce site utilise des cookies

Nous utilisons des cookies pour assurer le bon fonctionnement du site. Vous pouvez consulter nos mentions légales et notre politique de confidentialité pour plus d'informations.