Fertiliser Working Group meeting Feedback on projects for Plant biostimulants and Agronomic Fertiliser Additives Fertiliser Working Group meeting 15-16.12.2014 This position reflects the current stage of internal discussions in DG ENTR F.2 and not necessarily any future Commission proposal

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

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

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

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

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

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

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.

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.

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

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.

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.

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"

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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

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

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