10. Classification and labelling
Proposal for the classification and labelling of the formulation
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: - Signal word: -
H-statements: -
P-statements: P280c Wear protective gloves and protective clothing.
Supplemental Hazard information:
EUH208 Contains propyl gallate. May produce an allergic reaction.
EUH210 Safety data sheet available on request.
EUH401 To avoid risks to human health and the environment, comply with the instructions for use.
SP 1 Do not contaminate water with the product or
Child-resistant fastening obligatory? not applicable
Tactile warning of danger obligatory? not applicable
Explanation:
Pictogram: -
H-statements: -
P-statements: Based on the risk assessment for the operator, gloves and coverall are needed (P280c).
Other: -
* 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:
Maak geen pre-mix van MaxCel. Vul de tank half met water en activeer de roerinstallatie. Voeg de noodzakelijke hoeveelheid MaxCel toe. Het product dispergeert beter door voorzichtig te roeren. Te hard roeren kan leiden tot overmatige schuimvorming. Vul voorzichtig roerend de tank aan tot het noodzakelijke volume.
Veiligheidstermijn:
De termijn tussen de laatste toepassing en de oogst mag niet korter zijn dan 90 dagen voor appels en peren.
(As the legal instructions for use are in the WG format, the 90 days PHI described in this sentence is included in the WG table.)
Om in het water levende organismen te beschermen is toepassing in de teelt van appels en peren in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan wanneer gebruik wordt gemaakt van één van de volgende maatregelen:
- een windhaag op de rand van het rijpad in combinatie met éénzijdige bespuiting van de laatste bomenrij in de richting van het perceel met inachtneming van een teeltvrije zone van tenminste 3 meter;
- een tunnelspuit met inachtneming van een teeltvrije zone van tenminste 3 meter;
- een Wannerspuit met reflectieschermen en standaard spuitdoppen met inachtneming van een teeltvrije zone van tenminste 3 meter;
- minimaal 50 % driftreducerende spuitdoppen in combinatie met éénzijdige bespuiting van de laatste bomenrij in de richting van het perceel met inachtneming van een teeltvrije zone van tenminste 3 meter;
- een KWH k1500-3R2 VLOS 3-rijenspuit met variabele luchtondersteuning en standaard spuitdoppen in de eerste 20 meter grenzend aan het oppervlaktewater met inachtneming van een teeltvrije zone van tenminste 3 meter
Appendix 1 Table of authorized uses; MaxCel – 20 g/l 6-benzyladenine
Pests or Group of pests controlled
Application Application rate per treatment PHI
(days)
Remarks:
a) max. no. of applications per crop and season
b) Maximum product rate per season c) additional remarks
Method / Kind
Timing / Growth stage of crop &
and improved return bloom
Airblast spraying
BBCH 71-74 Best results when average king fruitlet diameter is 7-15 mm
BBCH 71-72 Best results when average king fruitlet diameter is 10-12 mm
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 Appli-cation
number*
Date of submis-sion*
IIIA 2.1-01
2010b VBC-30127 Accelerated Storage Stability.
Huntingdon Life Sciences Ltd.
Report no. ZAB0124.
GLP, Unpublished.
Y Valent Biosciences
IIIA 2.2.1-01
2010a VBC-30127 Physico-Chemical Properties.
Huntingdon Life Sciences Ltd.
Report no. ZAB0122.
GLP, Unpublished.
Y Valent Biosciences
IIIA 2.7.4-01
2010c VBC-30127 Low Temperature Stability.
Huntingdon Life Sciences Ltd.
Report no. ZAB0123.
GLP, Unpublished.
Y Valent Biosciences
IIIA 2.7.5-02
2013 VBC-30127 Three Year Storage Stability (Interim report, 2 year data) Huntingdon Life Sciences Ltd., UK, Report No ZAB0126
Sponsor: Valent Biosciences Corporation.
GLP, unpublished
Y Valent Biosciences
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 Appli-cation
number*
2004 Validation of a HPLC method for the determination of 6-benzyladenine content in VBC-30001 formulation.
Valent Biosciences Corporation, Long Grove, Illinois, U.S.A., Project VBC LG-C-04-04-2002 Sponsor: Valent Biosciences Corporation
Not GLP, unpublished
Y Valent BioSciences 2-11-2015
IIIA 5.3/01 1996 Determination of 6-benzyladenine residues in apple and pear.
NEOTRON S.r.l., Vignola, Italy NEOT/GLP/LN52B-95 GLP, unpublished
Y Valent BioSciences 2-11-2015
IIIA 5.3/02 2015 Independent Laboratory Validation the method described in Determination of 6-Benzyladenine on Apple and Pear
Valent Biosciences Corp., Long Grove, IL, USA VBCL15-48060-04
GLP, unpublished
Y Valent BioSciences
IIIA 7.6.2 2010 6-Benzyladenine: The in Vitro dermal absorption of radio labelled 6-Benzyladenine in the concentrate and two in use spray dilutions through rat and human skin.
CR Study No: 787786, report No:31224 GLP, not published
Y Valent BioSciences Corporation
IIIA 8.2-01 2011 The natural occurrence of 6-Benzyladenine (6-Benzylaminopurine, 6-BA, BAP) in edible crops.
Valent BioSciences Corporation Test Facility Study No. 6-BA 20111306
Y Valent
IIIA,
10.2.2.1/01 2010a VBC-30127 A 96-hour static acute toxicity test with the rainbow trout (Oncorhynchus mykiss).
Report No 529A-115 GLP, unpublished
2010b VBC-30127: A 48-hour static acute toxicity test with Cladoceran (Daphnia magna) Wildlife International
Report No: 529A-114A GLP, unpublished
2008 Algae growth inhibition with Pseudokirchneriella subcapitata (syn. Selenastrum capricornutum) under static conditions.
Springborn Smithers Laboratories (Europe)
Y Valent
Biosciences Corporation
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 Appli-cation
number*
2009 VBC-30127: Alga, growth inhibition test with Pseudokirchneriella subcapitata (syn.
Selenatrum capricornutum) under static conditions.
Springborn Smithers Laboratories (Europe) Report No 1042.018.430 GLP, unpublished
2010a VBC-30127: Growth inhibition test with Navicula pelliculosa under static conditions.
Report No 1042.021.440 GLP, unpublished
2005a MAXCEL: An Acute Oral Toxicity Study with the Honey Bee Wildlife International, Ltd.
Project/Report #: 529-108 GLP, unpublished
Y Valent BioSciences
Corporation
IIIA, 10.4.2.2/01
2005b MAXCEL: An Acute Contact Toxicity Study with the Honey Bee Wildlife International, Ltd.
Project/Report #: 529-107.
GLP, unpublished
Y Valent BioSciences
Corporation
IIIA, 10.5.1/01
2010a Effects of VBC-30127 on the predatory mite Typhlodromus pyri (SCHEUTEN) in the laboratory test – Rate-Response-Test.
BioChem agrar, Labor fur biologische and chemische Analytik GmbH, Germany Report No 10 10 48 010A
GLP, unpublished
Y Valent BioSciences
Corporation
IIIA, 10.5.1/02
2010b Effects of VBC-30127 on the parasitic wasp Aphidus rhopalosiphi (DESTEFANI-PEREZ) in a laboratory test – Rate-Response-Test.
BioChem agrar, Labor fur biologische and chemische Analytik GmbH, Germany Report No 10 10 48 009 A
GLP, unpublished
Y Valent BioSciences
Corporation
IIIA, 10.8.1 2008 6-Benzyladenine: terrestrial (non-target) plant growth test vegetative vigor Huntingdon Life Sciences, Alconbury, Huntingdon, Cambs. PE23 4HS, UK Report No ZAB0085
GLP, Unpublished
Y Valent
Biosciences Corporation
IIIA, 10.8.2.1/01
2010b VBC-30127: Growth inhibition test with the freshwater duckweed (Lemna gibba) under semi-static conditions.
Springborn Smithers Laboratories (Europe) Report No 1042.021.410
GLP, Unpublished
Y Valent
Biosciences Corporation
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 Appli-cation
number*
Date of submis-sion*
KIIIA-6.0/0 2012 Biological Assessment Dossier of MaxCel (VBC-30001 & VBC-30127) SL (Soluble Concentrate), Central and Southern Zone Countries.
Sumitomo Chemical Agro Europe S.A.S.
Document No.: VBC-MaxCel-12-1-B7
Y VBC
2001 Etude d`efficacité du VBC 30001 sur l`éclaircissage chimique du pommier Variété Brookfield Baigent
Report No. 1RC 119 2001 / 2001JBALL014 GEP, not published
N VBC
2003 Biological Evaluation of VBC30001 on Fruit Thinning on Jonagored Trial 2002 Report No : 20030707 332 BE 359 GEP
GEP, not published
N VBC
2003 Etude d`efficacité du VBC 30001 sur l`éclaircissage chimique du pommier Variété Brookfield Baigent
Report No. 1RC 119 03 GEP, not published
N VBC
2004 Fruit thinning efficacy of VBC-30001 in Elstar apples Report No. 2004-26 / 2003JBALL041
GEP, not published
N VBC
2006 Field test to evaluate the efficacy of MaxCel for fruit thinning in apples and to generate GEP data
Report No. 05OD312-A1 / 2005MSCHR432 GEP, not published
N VBC
KIIIA-6.1.2/70 KIIIA-6.1.3/70 KIIIA-6.2.1/70 KIIIA-6.6/70
2006 Field test to evaluate the efficacy of MaxCel for fruit thinning in apples and to generate GEP data
Report No. 05OD312-A2 / 2005MSCHR433 GEP, not published
N VBC
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 Appli-cation
number*
2006 Field trial to evaluate the efficacy and crop safety of the chemical fruit thinner MaxCel (20 g Benzyladenin/L) in apples
Report No. 2005MSCHR492 GEP, not published
N VBC
2006 Untersuchungen zur Wirksamkeit und Erntesicherheit des chemischen
Fruchtausdünnungsmittels MaxCel (20 g Benzyladenine/L) bei der Apfelsorte Gala Dienstleistungszentrum Ländlicher Raum –
Report No: GW202.05 /2005MSCHR494 GEP, not published
N VBC
2006 MaxCel: Chemische Fruchtausdünnung nach Richtlinie PP 1/158 (2) Report No.: WA70/05D / 2005MSCHR495
GEP, not published
N VBC
2005 Fruchtausdünnung mit MaxCel bei Elstar 2005 Report No. 2005MSCHR496
GEP, not published
N VBC
2006 MaxCel-Fruchtausdünnung an Äpfeln Report No. GOO2005-O25 / 2005MSCHR497 GEP, not published
N VBC
2008 Efficacy test for fruit thinning in apples with MaxCel (VBC 30001, 20 g benzyladenine/L) Report No : 07OB18-A1 / 2007MSCHR430
GEP, not published
Y VBC
2008 Field trial to evaluate the efficacy and crop safety of the chemical fruit thinner MaxCel (20 g benzyladine/l) on ‘Cox Orange’ apples
Report No. 2007MSCHR490 GEP, not published
Y VBC
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 Appli-cation
number*
2008 Fruit thinning of “Cox Orange” apples with MaxCel (VBC 3001) Report no. 2007, OVA Jork, 07127WFS001 / 2007MSCHR492 GEP, not published
Y VBC
2009 Field study to evaluate the efficacy and crop safety of the chemical fruit thinner MaxCel (VBC 30001, 20 g Benzyladine/l) on ‘Cox Orange Pippin’ apples
Report No. 2008MSCHR500 GEP, not published
Y VBC
2009 Fruit thinning of “Cox Orange” apples with MaxCel (VBC 30001) Landwirtschaftskammer Niedersachsen, Germany
Report No : 2008, OVA jork, 08127WFS004 / 2008MSCHR501 GEP, not published
Y VBC
KIIIA-6.1.3/98 KIIIA-6.2.1/98 KIIIA-6.6/98 KIIIA-6.7/98
2011 Field study to evaluate the efficacy and crop safety of the chemical apple fruit thinner MaxCel (VBC 30001) in Poland
Report No. 2010MSCHR486 GEP, not published
Y VBC
KIIIA-6.1.3/99 KIIIA-6.2.1/99 KIIIA-6.6/99 KIIIA-6.7/99
2011 Field study to evaluate the efficacy and crop safety of the chemical apple fruit thinner MaxCel (VBC 30001) in Poland
Report No. 2010MSCHR487 GEP, not published
Y VBC
2011 Field study to evaluate the efficacy and crop safety of the chemical apple fruit thinner MaxCel (VBC 30001) in Poland
Report No. 2010MSCHR488 GEP, not published
Y VBC
KIIIA-6.1.3/101 KIIIA-6.2.1/101
2011 Field study to evaluate the efficacy and crop safety of the chemical apple fruit thinner MaxCel (VBC 30001) in Poland
Report No. 2010MSCHR489 GEP, not published
Y VBC
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 Appli-cation
number*
2010 Fruit thinning study on ‘Golden Delicious’ apples to evaluate the efficacy and crop safety of two new 6-BA formulations 30127) and 30128) in comparison with MaxCel (VBC-30001, 20g/l 6-Benzyladenin)
Report No. 2009MSCHR497 GEP, not published
Y VBC
2010 Fruit thinning study on ‘Elstar’ apples to evaluate the efficacy and crop safety of two new 6-BA formulations (VBC-30127) and( VBC-30128) in comparison with MaxCel (VBC-30001, 20g/l 6-Benzyladenin)
Report No. 2009MSCHR498 GEP, not published
Y VBC
2010 Fruit thinning study on ‘Jonagold’ apples to evaluate the efficacy and crop safety of the new BA formulations (VBC-30127) in comparison with MaxCel (VBC-30001, 20g/l
6-Benzyladenin)
Report No. 2010MSCHR511 GEP, not published
Y VBC
2010 Fruit thinning study on ‘Braeburn’ apples to evaluate the efficacy and crop safety of two new 6-BA formulations (VBC-30127) and( VBC-30128) in comparison with MaxCel (VBC-30001, 20g/l 6-Benzyladenin).
Report No. 2009MSCHR493 GEP, not published
Y VBC
2010 Field test to compare two new formulations of 6-BA (VBC-30127 and VBC-30128) with MaxCel (VBC 30001) for fruit thinning in apples.
Report No. 2009MSCHR439 GEP, not published
Y VBC
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 Appli-cation
number*
2010 Field test to evaluate the efficacy of a new 6-BA formulation (VBC-30127) as a fruit thinner on apple
Report No. 2010MSCHR439 GEP, not published
Y VBC
2010 Field test to evaluate the efficacy of a new 6-BA formulation (VBC-30127) as a fruit thinner on apple
Report No. 2010MSCHR440 GEP, not published
Y VBC
2010 Fruit thinning study on ‘Golden Delicious’ apples to evaluate the efficacy and crop safety of the new BA formulations (VBC-30127) in comparison with MaxCel (VBC-30001, 20g/l 6-Benzyladenin)
Report No. 2010MSCHR510 GEP, not published
Y VBC
2011 Fruit thinning study on apple to evaluate the efficacy and crop safety of a new 6-BA formulation (VBC-30127) in comparison with MaxCel (VBC 30001)
Report No. 2011MSCHR480 GEP, not published
Y VBC
2011 Fruit thinning study on apple to evaluate the efficacy and crop safety of a new 6-BA formulation (VBC-30127) in comparison with MaxCel (VBC 30001)
Report No. 2011MSCHR481 GEP, not published
Y VBC
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 Appli-cation
number*
2011 Fruit thinning study on apple to evaluate the efficacy and crop safety of a new 6-BA formulation (VBC-30127) in comparison with MaxCel (VBC 30001)
Report No. 2011MSCHR482 GEP, not published
Y VBC
2011 Fruit thinning study on apple to evaluate the efficacy and crop safety of a new 6-BA formulation (VBC-30127) in comparison with MaxCel (VBC 30001)
Report No. 2011MSCHR483 GEP, not published
Y VBC
KIIIA-6.1.4/123 KIIIA-6.7/123
2009 Evaluation of unintentional taint effects of MaxCel (VBC-30001) at 150 ppm a.i. applied as a chemical thinner on three apple cultivars (Gala, Golden, Granny).
Report No. 2009MSCHR809
Y VBC
KIIIA-6.1.4/124 KIIIA-6.7/124
2011 Study to evaluate unintended effects on taint of processed apples by 6-BA fruit thinning formulations (VBC-30001 and VBC-30127).
Report No. 2010MSCHR527
Y VBC
KIIIA-6.1.1/60 2011 Creating a successful thinning program based on MaxCel® for increased fruit size in
‘Blanquilla’ pear. Last report of the contract signed with: Company: Kenogard.
1. Contract code V2056 2. Organic code 1200 Non-GEP, unpublished
2008 Final Report. Biological Efficacy Evaluation of MaxCel (VBC 30001) (20 g/l SL) on Thinning on Pear cv. ‘Conference’. Trial 2004.
VBC Study number: 2004MSCHR321 GEP, unpublished
2012 Evaluation of VBC-30127 (PAG11001) in pear orchards for the efficacy on fruit thinning.
Final report trial number 2011MSCHR310 Trial location: Randwijk, The Netherlands.
GEP, unpublished
Y VBC
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 Appli-cation
number*
2012 Evaluation of VBC-30127 (PAG11001) in pear orchards for the efficacy on fruit thinning.
Final report trial number 2011MSCHR311 Trial location: Maurik, The Netherlands.
GEP, unpublished
2012 Evaluation of VBC-30127 (PAG11001) in pear orchards for the efficacy on fruit thinning.
Final report trial number 2011MSCHR312 Trial location: Waardenburg, The Netherlands.
GEP, unpublished
2012 Effect on fruit thinning by VBC-30127 (PAG11001) in pear.
Project number Bredelaar: G-11-3234 Project number sponsor: G11.8122.TF.TP3
Trial numbers included: G-11-3234-1 (2011MSCHR313 / G-11-8122.TF-3.BRE-1) GEP, unpublished
2012 Effect on fruit thinning by VBC-30127 (PAG11001) in pear.
Project number Bredelaar: G-11-3234 Project number sponsor: G11.8122.TF.TP3
Trial numbers included: G-11-3234-2 (2011MSCHR314 / G-11-8122.TF-3.BRE-2) G GEP, unpublished
Y VBC
2012 Effect on fruit thinning by VBC-30127 (PAG11001) in pear.
Project number Bredelaar: G-11-3234 Project number sponsor: G11.8122.TF.TP3
Trial numbers included: G-11-3234-3 (2011MSCHR315 / G-11-8122.TF-3.BRE-3) GEP, unpublished
Y VBC
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 Appli-cation
number*
Date of submis-sion*
KIIIA-6.1.3/87 KIIIA-6.1.4.1/87 KIIIA-6.1.4.3/87 KIIIA-6.2.1/87 KIIIA-6.6/87 KIIIA-6.7/87
2011 Report 2011 on: “Fruit thinning study to evaluate the efficacy and crop safety of MaxCel (VBC-30127/30001) in comparison to an untreated control on pears”
Trial number 2011MSCHR484 GEP, unpublished
Y VBC
KIIIA-6.1.3/88
KIIIA-6.1.4.3/88 KIIIA-6.2.1/88 KIIIA-6.6/88 KIIIA-6.7/88
2012 Fruit thinning study to evaluate the efficacy and crop safety of MaxCel (VBC-30127) on pear in Germany. Final Report. Study No.: VP11-4-30. Trial No. VP11-30D1. Sponsor’s Project No:
2011MSCHR497 GEP, unpublished
Y VBC
KIIIA-6.1.3/89 KIIIA-6.2.1/89 KIIIA-6.6/89 KIIIA-6.7/89
2011 Fruit thinning study to evaluate the efficacy and crop safety of MaxCel (VBC-30127) on pear in Germany. Final Report. Study No.: VP11-4-30. Trial No. VP11-30D2. Sponsor’s Project No:
2011MSCHR498 GEP, unpublished
Y VBC