1. Fertiliser Working Group meeting
Feedback on projects for Plant biostimulants and Agronomic Fertiliser Additives
Fertiliser Working Group meeting
This position reflects the current stage of internal discussions in DG ENTR F.2 and not necessarily any future Commission proposal

2. Objectives to be achieved, general drivers
Create an internal market for fertilising products
Eliminate existing trade barriers
Address safety concerns
Stimulate innovation
Reduce administrative burdens
Facilitate controls

3. Objectives to be achieved, specific drivers
Address the specificities of this family of substances and microorganisms: no possible generic essential requirements
Recognise their functionalities in relation with the nutrition of plants, either by acting on the plant biological processes (plant biostimulants = "PB") or on the nutrients (agronomic fertilisers additives = "AFA")
Distinguish them from products which influence plant pests, preserve plant products, destroy plants, prevent plant growth = PPP

4. Objectives to be achieved, drivers (2)
Address the dual use products (both PB+PPP functionalities) in a clear and fair way
Recognise the specific intrinsic properties = risks to human, animal and plant health to be examined differently than for fertilising products
Granting access to market in a straight-forward and proportionate manner but condition it to the submission of data proving absence of unacceptable risks and data confirming functionalities = REGISTRATION

5. Objectives to be achieved, drivers (3)
Collect the necessary information through registration:
Submit data that are necessary to prove acceptable level of risks and confirm the functionalities as PB or AFA
Waive what is not necessary or has already been submitted (REACH,…)
Exempt the non-risky substances, where relevant
Organise data protection/sharing/compensation rules in a fair manner towards both "data rich" registrant and co-registrants

6. Consultation since last Fert. WG
2 workshops organised by EBIC (some MS present):
Dual Use + microbials
Discussion with DG SANCO (PPP)
Informal discussion with ECHA

7. What's new since last WG?
The future Regulation should apply on the placing on the market of fertilising products
PB and AFA are considered as :
"ingredients" of fertilising products to be registered in the Union Register
substance (in the sense of REACH) or microorganism and not mixture or commercial preparation
To facilitate market access for mixtures of safe substances, registration obligation should apply to PB or AFA substance or microorganism, not to the commercial mixture containing it

8. Why this change?
Data sharing can only work if the registration applies at substance level
Registration of "PB or AFA mixture" would have created an obligation to register all fertilising products containing them.
Any change in the composition of the mixture would have to be signaled or would trigger the need for another registration number, contrary to our intention to keep the register at a manageable level.
We did not want to transform the registration into an autorisation approach.

9. Why this change? Consequences?
Hence:
several draft definitions have been modified.
Data requirements now focus on substance or microorganism data
Data sharing would be possible among co-registrants of the substance
No need to register for each commercial preparation, but also no way to "artificially" protect very similar PB or AFA by the rules on data protection.

10. Definitions Fertilising materials
substance, micro-organism, mixture or other material
as supplied for final use
for the purpose of
providing plants with nutrient or
improving their nutrition efficiency or their growth conditions
exempted: e.g. plant protection products

11. Definition of a plant biostimulant Current working definition
A substance in a fertilising product, which independently of its nutrient content stimulates plant biological processes thus improving the plant nutrient use efficiency, its tolerance to abiotic stress or its crop quality traits, or
A microorganism in a fertilising product.

12. Definition of an agronomic fertiliser additive
Current working definition
A substance in a fertilising product improving its agronomic efficacy or modifying the environmental fate of nutrients.

13. Scoping with Plant Protection Products Regulation
Article 2(1)(b) of PPPR to read as follows: "influencing the life processes of plants other than by improving the plants' nutrient use efficiency, their tolerance to abiotic stress or their crop quality traits, or as a nutrient"

14. Regulation of fertilising products: "New Approach"
Essential safety and quality requirements
products manufactured in conformity with harmonised standards are presumed to conform to essential requirements
standards are not mandatory
Confirmation of conformity:
self certification or
certification by notified bodies

15. Additional requirements for certain ingredients
Fertilising product consisting of or intentionally incorporating a plant biostimulant or an agronomic fertiliser additive, on its own or in a mixture may be place on the market only if the PB or the AFA has been registered for the intended use of the fertilising product and the intended use is communicated to the user of the fertilising product

16. Registration of PB and AFA
Registration of the PB substance or the PB microorganism or the AFA substance in an ECHA/Union register
A fertilising product consisting of or containing a plant biostimulant cannot be placed on the market unless the substance or microorganism is registered

17. Information requirements
Safety assessment & safety report mandatory for all
Demonstration that one of the functionalities provided by the definition is at least fulfilled
Information requirements vary between
Chemical PB and AFA
Microbiological PB

18. Tiered approach for information requirements
Tier 1 : Hazard assessement
Tier 2 : Exposure assessment + risk characterisation
Trigger for moving to Tier 2:
Chemical PB or AFA  The same CLP-classification criteria as under REACH registration
Microbiological Plant Biostimulant  Human pathogen

19. Information requirements for a chemical PB or AFA dossier (1)
General Registrant Information
Identification of the plant biostimulant
Information on manufacturing and functionalities
Classification and labelling
Physicochemical properties
Toxicological information
Skin irritation or skin corrosion
Eye irritation
Skin sensitisation
Mutagenicity
Acute toxicity
Repeated dose toxicity
Further information related to reproductive toxicity and toxicokinetics

20. Information requirements – waiving opportunities (<REACH, CLP, PPPR,…)
General Registrant Information
Identification of the plant biostimulant
Information on manufacturing and functionalities
Classification and labelling
Physicochemical properties
Toxicological information
Skin irritation or skin corrosion
Eye irritation
Skin sensitisation
Mutagenicity
Acute toxicity
Repeated dose toxicity
Further information related to reproductive toxicity and toxicokinetics

21. Information requirements for a chemical PB or AFA dossier (2)
Ecotoxicological information
Aquatic toxicity
Degradation
Biotic, ready biodegradability?
Abiotic, hydrolysis as a function of pH?
Fate and behaviour in the environment
Efficacy data

22. Information requirements for a chemical plant biostimulant dossier - waiving opportunities
Ecotoxicological information
Aquatic toxicity
Degradation
Biotic, ready biodegradability?
Abiotic, hydrolysis as a function of pH?
Fate and behaviour in the environment
Efficacy data

23. Information requirements for a microbiological dossier
Registrant Information
Identification of the microorganism (or the "microbial consortium"?)
Biological properties of the microorganism(or the "microbial consortium"?)
Methods of detection and identification
Functionalities corresponding to the definition of PB
Intended uses and exposure
Toxicological information
Ecotoxicological information
Environmental fate and behaviour
Recommended risk mitigation measures
Summary and evaluation

24. Information requirements - microorganisms waiving opportunities (PPPR or scientific literature)
Registrant Information
Identification of the microorganism (or the "microbial consortium"?)
Biological properties of the microorganism(or the "microbial consortium"?)
Methods of detection and identification
Functionalities corresponding to the definition of PB
Intended uses and exposure
Toxicological/pathogenicity information
Ecotoxicological information
Environmental fate and behaviour
Recommended risk mitigation measures
Summary and evaluation

25. Union Register Managing the Register (1): ECHA
Registration fees + annual fees
Completeness/compliance check: deadline imposed on ECHA + 'stop the clock' if dossier is incomplete
Allocation of registration number: unique identifier for the whole EU market
Data protection/data sharing
Market surveillance by MS

26. Union Register Managing the Register (2)
Re-assessment by Member State: access to data submitted to ECHA
Conclusions by Rapporteur MS could lead to:
Emergency situation: safeguard clause (limited to its territory)
No change: registration remains as it is
Conditions of registration or registration itself are put in question: peer-review to be organised by ECHA: expert group (annual fees to cover these tasks)
Either peer-review confirms the registration
Or peer-review confirms the need to adapt registration (e.g. conditions of use)
Or peer-review confirms the need to cancel registration (Commission decision to list the product on the negative list - comitology)

27. ECHA MS JOINT DATA SUBMISSION REGISTRATION COMPLETENESS CHECK
Lead Registrant
Co-Registrant
Pre-
registration
Co-Registrant
Co-Registrant
Co-Registrant
JOINT DATA SUBMISSION
REGISTRATION
Registration
COMPLETENESS CHECK
FEE PAYMENT
REGISTRATION NUMBER
UNION REGISTER
Access to market
Evaluation
ECHA
DOSSIER EVALUATION
SUBSTANCE EVALUATION MS

28. Dossier evaluation Initiator = ECHA 50% of all dossiers submitted
At the latest 12 months after registration number has been issued
Analysis of
Compliance of technical information with information requirements
Justification for data waivers
Adequacy of proposed risk management measures
ECHA may issue draft decision requiring registrant to submit additional information
Request for review by MS possible

29. Substance evaluation Initiator = MS
MS makes known to ECHA its intention to review a registration
ECHA makes related data available to MS
Within 365 days, MS to send assessment report and conclusions to ECHA
ECHA to organize peer review and to prepare opinion
ECHA submits opinion to Commission

30. Substance evaluation – decision process
Initiating MS
ECHA – peer review
Commission +
Adopts approval -
Has final decision power