Plant nutrition

Staphyt Regulatory can advise and support you in all the regulatory procedures for placing your plant nutrition products on the European market, as per Regulation (EC) No.2003/2003 and/or at national level as per local regulations.

Our team has prepared and submitted a host of Product Authorisation application dossiers for fertilising substances and growing media. It has also carried out regulatory advice, study monitoring, dossier auditing and bibliographic search missions.

Thanks to this experience, our team has supported numerous customers in regulatory strategy, in particular enabling them to optimise their registration costs.

You need to

Understand and keep track of EU and national regulations in this field,
Assist you with any regulatory issue,
Analyse available data, identify missing data,
Set up laboratory and field studies,
Obtain a Product Authorisation in France (AMM),
Place on the French market one of your products already marketed in another European country,
Check under what conditions your product can be marketed in various European Union countries,
Submit registration dossiers as per the national authorisation procedures for your products in any other European country,
Submit Anti-Poison Centre declarations for hazardous products placed on the European market.

Our expertise

Keep track of changes to the regulations, and provide regulatory watch tailored to your needs in the field of plant nutrition
Assist you with any regulatory issue
Identify whether your product meets the criteria of Regulation (EC) No.2003/2003, of a mandatory French standard (NF U XX-XXX), or authorisation criteria in other European Union countries
Assess the existing studies and identify missing studies for the purposes of putting together an application dossier
Monitor studies by COFRAC accredited laboratories and GEP crop trials, obtain comprehensive, high-quality test reports within the allotted time frame
Produce an experimental use permit application
Summarise the data and draw up the marketing authorisation application dossier (AMM) (Cerfa administrative form, administrative and technical dossiers)
Prepare a mutual recognition dossier in France if your product is authorised in another European Union country, and vice-versa
Carry out the authorisation applications for your product in various European countries,
Submit the dossiers to the competent authorities and keep in contact with them to ensure that the procedures run smoothly,
Respond to new requirements, answer questions from the authorities, prepare pitches, etc.
Determine, check or adapt the CLP classification and the labelling of your products, and prepare safety data sheets (including extended SDS) for your substances and products, according to European regulations and specific national provisions
Declare your products to Anti-Poison Centres (Art. 45 CLP) of European Member States (including France via SYNAPSE/INRS)
Conduct tailored training (technical or regulatory)
Translate all types of document

Other business areas

Plant protection

Biocides

Chemical substances (REACH)

Cosmetics

Medecines

Our services

Registration dossiers for substances and products: plant nutrition

Risk assessment

Strategy, advice and regulatory watch

Field and laboratory studies management

Classification, SDS, labelling

Alternative to laboratory studies: QSAR, expert statement, literature search

Regulatory training

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Your contact

Geoffroy Moulin

Plant Protection & Nutrition Technical & Sales Adviser

+33 (0)6 64 35 08 54

gmoulin@staphyt.com

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