Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labeling of the preparation is proposed:
The identity of all substances in the mixture that contribute to the classification of the mixture *:
-
Pictogram: GHS07 Signal word: warning
H-statements: H319 Causes serious eye irritation.
H412 Harmful to aquatic life with long lasting effects.
P-statements: P273 Avoid release to the environment.
P337+P313 If eye irritation persists: Get medical advice/attention.
P391 Collect spillage.
P501 Dispose of contents/container to … Supplemental Hazard
information:
EUH401 To avoid risks to human health and the environment, comply with the instructions for use.
SP1 Do not contaminate water with the product or its container
Child-resistant fastening obligatory? n.a.
Tactile warning of danger obligatory? n.a.
Explanation:
Pictogram: -
H-statements: H319 is assigned based on studies with the formulation.
The labelling of the mixture is based on the summation method for the active substance. This method requires ecotoxicity endpoints from acute/chronic studies, information on degradation and the concentration in the product. Data were obtained from the EFSA-conclusion for flutolanil.
P-statements: P280 is assigned based on H319. Other P-statements were proposed by applicant, proposal accepted Other: According to Reg. (EC) 547/2011 all plant protection
products shall be labelled with the supplement phrase SP1.
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
The following restriction and warning sentences have to be included in the legal instructions for use:
None.
Appendix 1 Table of authorised uses: Symphonie – flutolanil 60 g/kg.
Appendix 2 Reference list
This appendix serves only to give an indication of which data have been used for decision making for the first time; as a result of concurring
applications for authorisations, the data mentioned here may have been used for an earlier decisions as well. Therefore, no rights can be derived from this overview.
Deze appendix geeft een indicatief overzicht van de gegevens die voor het eerst gebruikt zijn ten behoeve van een besluit; het kan echter voorkomen dat (onder andere) door een samenloop van aanvragen, de hier opgenomen gegevens al eens eerder gebruikt zijn. Aan dit overzicht kunnen dan ook geen rechten ontleend worden.
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
Date of submission*
IIIA 2.1 2.7.1
1997 Determination of physic-chemical characteristics and storage stability Rhone-Poulenc Agro
Report No. 97-149 GLP: Yes
Unpublished
Y Nihon
Nohyaku Co., Ltd
IIIA 2.2.1 2.2.2 2.3.2 2.3.3
1997 Determination of the lower explosion limit of dispersed dust, explosion properties, flammability, ability for self heating and oxidizing properties of EXP10057A.
Safety Process Laboratory Rhone Poulenc Report No. 97-150
GLP: Yes Unpublished
Y Nihon
Nohyaku Co., Ltd
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
2007 Symphonie DP: Determination of the Physico-Chemical Properties.
ChemService S.r.l.
Report No. CH-148/2006 GLP: Yes
2007 Symphonie DP: Determination of the accelerated storage stability and corrosion characteristics
ChemService S.r.l.
Report No. CH-150/2006 GLP: Yes
2009 Symphonie DP: Two years storage stability and corrosion characteristics.
Nihon Nohyaku Co., Ltd ChemService S.r.l.
Report No. CH-151/2006 GLP: Yes
2007 Symphonie DP: Validation of the analytical method for the determination of the active ingredient content
ChemService S.r.l.
Report no. CH-149/2006 GLP: Yes
Unpublished
Y Nihon
Nohyaku Co.
Ltd
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
Date of submission*
IIIA 5.3.1/01
2007 Validation of analytical method for flutolanil and its metabolites in potato.
Nihon-Nohyaku, Japan Report No. LSRC-A07-133A GLP: Yes
2008 To conduct an independent validation of the analytical method described in study protocol number GE-04, 07-0121 for the analysis of flutolanil and its metabolites M-2 and M-4 in potato.
Agrisearch
Report No. AD/12526/NN GLP: Yes
2008 Validation of analytical method for flutolanil and its metabolites in potato (revalidation).
Nihon-Nohyaku, Japan Report No. LSRC-A07-170A.
GLP: Yes
2008 Independent laboratory validation of methodology for the determination of flutolanil and its two major metabolites in potato and analysis of supplied samples.
HLS, UK
Report No. NNH0142 GLP: Yes
2011 Flutolanil: Validation of methodology for the determination of residues of flutolanil and metabolites M-2 and M-4 in potato.
Huntingdon Life Sciences Report No. LMS0047 GLP: Yes
Unpublished
Y Nihon
Nohyaku Co.
Ltd
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
Date of submission*
IIIA 6.0/01
2011 Biological Assessment Dossier for RHINO DS / SYMPHONIE
A Dust Formulation containing 6% w/w Flutolanil (applied at up to 2.0 kg/1000 kg potatoes)
Assessment of the performance of the Product when used to Control Rhizoctonia solani in Potatoes
AG&E Consulting Services Ltd., UK GLP: No
2001 Seed Treatment. Control of Rhizoctonia (black scurf) in potatoes after treatments with flutolanil alone (as EXP 10066A FS or EXP10057A DS) and when co-applied with FUNGAZIL 100 SL (imazalil). UK 1999, field trials
Aventis
Report No. DD/00/85
Protocol Number(s): UKA99S48
Trials Ids: UN1, UT1, UR1, UR2, UR3 and UE1.
GEP: Yes
2003 Certis Potato Seed Treatment Trial 2003 Certis UK Ltd.
Trial protocol code. RECF006/pots/2003 GEP: Yes
1995 Seed Protection: Selectivity of potatoes to Flutolanil International Field Research
Aldhams Farm
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
2000 Seed Treatment: Tolerance of potatoes after treatment with flutolanil as FS (EXP10066A@450 g/l) and dust (EXP10057A@60 g/kg). UK 1999, field trials Rhone Poulenc Agriculture
Study No. UKA99S49 GEP: Yes
1993 Control of Rhizoctonia solani by a Tuberapplication of Symphonie before Planting of Industrial Potatoes
Rhone Poulenc Agriculture
Trial NB: NN192S02, NN292S02, NN392S02, NN 492S02 GEP: Yes
1991 Control of a Tuber-Infestation of Rhizoctonia solani on Potatoes by means of Powdering the Seed-Potatoes with Symphonie.
Rhone Poulenc Agriculture
Trial NB: NN191S02, NN291S02, NN391S02, NN491S02, NZ191S02, NZ291S02 GEP: Yes
2011 Evaluer L’efficacité d’OSCAR WG en application de traitement de tubercules contre la gale argentée de la pomme de terre. Justifier la dose cible de 1,33 Kg/T et comparer le mode d’application (OSCAR SYSTEM et UBV) en comparaison aux references.
Philagro
Study number: CE1 10 F63 GEP: Yes
2011 Gale argentée sur pomme de terre Philagro
Study number: 10 PDT GALE 002 GEP: Yes
Published: No
Y Nihon
Nohyaku Co.
Ltd
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
2011 Evaluate the Efficacy of Fungicide Products against Black scurf of Potato Philagro
Study number: PBN-10-7367-FR01 GEP: Yes
2011 Rhizoctone sur tubercules Essai Pommes de terre PHILAGRO Philagro
Study number: 10 pdt rhi 001 GEP: Yes
2011 Evaluer l’ efficacité de OSCAR WG; RIALTO et IOTA P en application de traitement de tubercules contre le rhizoctone brun de la pomme de terre. Justifier leurs dose cible et le mode d’application en comparaison aux references.
Philagro
Study number CE1 10 F89 GEP: Yes
2011 Test the efficacy of Oscar WG, PHF0910 and Iota P applied on tubers against Rhizoctonia Solani
2011 Test the efficacy of fungicides applied on tubers against Rhizoctonia Solani for registration purpose
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
2011 Fongicide – Pomme de Terre Rhizoctone brun – Efficacite Philagro
Study number: P10PHF090LG23 GEP: Yes
2009 Efficacité rhizoctone brun pour ré homologation de produits.
Philagro
Study number: PRE09F82 N° d’essais: 25, Rhizo CN1 GEP: Yes
1996a EXP 80175 A single dose toxicity study by the oral route in the rat (Limit test) Report no. 607301
GLP: Yes
1996b EXP80715A - Single dose toxicity study by the cutaneous route in the rat (Limit test).
Report No. 607302 GLP: Yes
1997 EXP80715A: Acute inhalation toxicity (nose only) study in the rat.
Report No. 282/488 GLP: Yes
1996c EXP80715A: Primary cutaneous irritation and corrosivity test in the rabbit (P.C.I.C.) 3 rabbits.
Report No. 607303 GLP: Yes
Unpublished
Y Nihon
Nohyaku Co., Ltd.
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
EXP80715A - Ocular irritation and reversibility test in the rabbit (OIR) - 3 rabbits Report No. 607304
GLP: Yes
2007 Field Soil Dissipation of Flutolanil in a Typical Potato growing Area following one Application of Flutolanil 40 SC under Field Conditions (The Netherlands – Season 2005).
2009 Flutolanil: Kinetic Modelling Analysis of Data from Field Soil Dissipation Studies Conducted in Europe Normalised to 20ºC and pF2 (Spray Application Trials).
Battelle UK Ltd. XG/09/002A GLP: No
2009 Flutolanil: Kinetic Modelling Analysis of data from field soil dissipation studies conducted in Europe normalised to 20°C and pF2 (Tuber Treatment Trials) Battelle Uk Ltd.
Report No. XG/09/002B GLP: No
2010a Predicted Environmental Concentrations of Flutolanil in Groundwater (PECgw) Following Application to Potatoes
Battelle Uk Ltd.
Report No. XG/09/002C GLP: No
Unpublished
Y Nihon
Nohyaku
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
Date of submission*
IIIA 9.6/02
2010c Predicted Environmental Concentrations in Groundwater (PECGW) using GeoPEARL following application of Flutolanil to potatoes in the Netherlands.
Battelle Uk Ltd
Report No. XG/09/002D GLP: No
2010b Kinetic Analysis of Flutolanil Water Sediment Study Data to Derive Modelling and Trigger Endpoint DT50 values
Battelle Uk Ltd.
Report No. XG/09/002G GLP: No
2011 Predicted Environmental Concentrations in Surface Water (PECSW) and Sediment (PECSED) for flutolanil following application to potatoes.
Battelle Uk Ltd.
Report No. XG/10/001C GLP: No
2009a Flutolanil 70 DF: Acute Toxicity to Aphidius Rhopalosiphi in the laboratory.
Huntingdon Life Sciences Report No. LMS0004 GLP: Yes
2009b Flutolanil 70 DF: Acute Toxicity to TYPHLORDORMUS PYRI in the laboratory.
Huntingdon Life Sciences Report No. LMS0005 GLP: Yes
Unpublished
Y
Nihon-Nohyaku Ltd
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
Date of submission*
IIIA 10.5.1/03
2009c Flutolanil 70DF: Evaluation of the effect on the rove beetle ALEOCHARA BILINEATA in the laboratory.
Huntingon Life Sciences Report No. LMS0007 GLP: Yes
Unpublished
Y
Nihon-Nohyaku Ltd
IIIA 10.5.1/04
2009d Flutolanil 70DF: Evaluation of the effects of pesticides on the carabid beetle POECILUS CUPREUS in the laboratory.
Huntindon Life Sciences Report No. LMS0011 GLP: Yes
Unpublished
Y
Nihon-Nohyaku Ltd
IIIA 10.6.2/01
1996 EXP80715A Acute toxicity (14-Day) to earthworms (EISENIA FOETIDA) Artificial soil method).
Rhône-Poulenc Agro Report No. SA 96436 GLP: Yes
Unpublished
Y
Nihon-Nohyaku Ltd
2015 Flutolanil: acute and reproductive toxicity to the Collembolan species Folmosia candida in natural soil containing treated potatoes.
Y Nichino
Europe
20110408 March 2015