2 prof robin presentation - fertasa...2017/01/02 · presentation •act 36 regulations and...
TRANSCRIPT
CEO Workshop14 September 2017
Registration of Fertilizers
CEO Workshop14 September 2017
Registration of Fertilizers
Robin BarnardTechnical Advisor : Fertasa
Vusi MasheleTechnical Assistant: Fertasa
Robin BarnardTechnical Advisor : Fertasa
Vusi MasheleTechnical Assistant: Fertasa
PresentationPresentation• Act 36 Regulations and Guidelines• New Developments• Applications: Requirements• Groups 1, 2 and 3• Requests / Needs / Working together• Regulations: Sections and Tables• Challenges
• Act 36 Regulations and Guidelines• New Developments• Applications: Requirements• Groups 1, 2 and 3• Requests / Needs / Working together• Regulations: Sections and Tables• Challenges
Fertasa WebsiteFertasa Website• Extremely useful information and links• Act 36 of 1947• Fertilizer Regulations• Table 12• Registrar of Fertilizer Information• Registration Forms• Contact Details• See also DAFF Website
• Extremely useful information and links• Act 36 of 1947• Fertilizer Regulations• Table 12• Registrar of Fertilizer Information• Registration Forms• Contact Details• See also DAFF Website
Fertilizers, Farm Feeds, Agricultural Remediesand Stock Remedies Act,
1947Act 36 of 1947(As Amended)
Regulations Regarding Fertilizers
Fertilizers, Farm Feeds, Agricultural Remediesand Stock Remedies Act,
1947Act 36 of 1947(As Amended)
Regulations Regarding Fertilizers
Current SituationCurrent Situation
• Regulations of September 2012 being amended• Guidelines for Group 3 Applications of February 2016
being updated• Act 36 of 1947 and New Act being debated• Current documents apply
• Regulations of September 2012 being amended• Guidelines for Group 3 Applications of February 2016
being updated• Act 36 of 1947 and New Act being debated• Current documents apply
Registration of FertilizersRegistration of Fertilizers
• Legal Requirements• Long Waiting Time• Frustrations• Problems?• Fertasa Interventions
• Legal Requirements• Long Waiting Time• Frustrations• Problems?• Fertasa Interventions
Application for RegistrationApplication for Registration• An application is to be made in terms of Section
3(1) of the Act• An application must be made by a person residing in the Republic
of South Africa, or in the case of a legal person that legal person shall have a registered office in the Republic
• Application to be signed by an authorized person• Be accompanied by the prescribed application fee which is
adjusted annually on 1 April• A signed analysis certificate from a reputable
laboratory• Certain other requirements
• An application is to be made in terms of Section 3(1) of the Act
• An application must be made by a person residing in the Republic of South Africa, or in the case of a legal person that legal person shall have a registered office in the Republic
• Application to be signed by an authorized person• Be accompanied by the prescribed application fee which is
adjusted annually on 1 April• A signed analysis certificate from a reputable
laboratory• Certain other requirements
Applications Through FertasaApplications Through Fertasa
• Assist Members and Non Members• Send a request• Respond with an invoice and requirements• Fertasa consultation fee, approximately R1000 – R2000• DAFF Fee – R4152• Consultation with client• Administrative aspects• Formulation table
• Assist Members and Non Members• Send a request• Respond with an invoice and requirements• Fertasa consultation fee, approximately R1000 – R2000• DAFF Fee – R4152• Consultation with client• Administrative aspects• Formulation table
Applications Through FertasaContinued…Applications Through FertasaContinued…
• Label• Spec Sheets• Analyses• Submission to DAFF• Follow up and Finalization
• Label• Spec Sheets• Analyses• Submission to DAFF• Follow up and Finalization
• Currently implementing an on-line registration system for applications through Fertasa
• Later hopefully coupled to a DAFF registration system and to a data base
• These being investigated currently• For the interim, Fertasa will submit hard
copies of applications to DAFF
• Currently implementing an on-line registration system for applications through Fertasa
• Later hopefully coupled to a DAFF registration system and to a data base
• These being investigated currently• For the interim, Fertasa will submit hard
copies of applications to DAFF
Applications Through FertasaContinued…Applications Through FertasaContinued…
• GROUP 1 – is a fertilizer containing a total equal or greater than 100 g/kg (10%) N, P or K or any combination thereof; or
• GROUP 2 – is a fertilizer containing a total of less than 100 g/kg of N, P or K or any combination thereof or any other recognized plant nutrient(s) in acceptable amounts as indicated in Tables 1 – 9 and 13 - 15
• GROUP 3 – is a fertilizer containing naturalor synthetic substance(s) or organism(s) thatimproves the growth or yield of plants or thephysical, chemical or biological conditionof the soil
• GROUP 1 – is a fertilizer containing a total equal or greater than 100 g/kg (10%) N, P or K or any combination thereof; or
• GROUP 2 – is a fertilizer containing a total of less than 100 g/kg of N, P or K or any combination thereof or any other recognized plant nutrient(s) in acceptable amounts as indicated in Tables 1 – 9 and 13 - 15
• GROUP 3 – is a fertilizer containing naturalor synthetic substance(s) or organism(s) thatimproves the growth or yield of plants or thephysical, chemical or biological conditionof the soil
Fertilizer GroupsFertilizer Groups
• Relevant constituents / analytes• Accurate, reliable, reproducible results• Within spec• Report on letterhead, signed, current (12 months)
• Relevant constituents / analytes• Accurate, reliable, reproducible results• Within spec• Report on letterhead, signed, current (12 months)
Analysis RequiredAnalysis Required
• An independent laboratory, using relevant analytical methods which are:
• Either ISO17025 accredited or ISO/IEC17025: 2005 SANAS accredited
• AgriLASA certified for the product which was obtained in the current year of application for registration; or
• OECD Good Laboratory Practices (GLP)• A DAFF recognised laboratory or any
reputable internationally recognised laboratory for the relevant analyses
• An independent laboratory, using relevant analytical methods which are:
• Either ISO17025 accredited or ISO/IEC17025: 2005 SANAS accredited
• AgriLASA certified for the product which was obtained in the current year of application for registration; or
• OECD Good Laboratory Practices (GLP)• A DAFF recognised laboratory or any
reputable internationally recognised laboratory for the relevant analyses
Reputable LaboratoryReputable Laboratory
• Client requests certain analyses• BUT, is this what is needed?• These are seldom the same!• Result: Incomplete analysis report• Come-backs, further requests• Delays• Frustration• Accusations
• Client requests certain analyses• BUT, is this what is needed?• These are seldom the same!• Result: Incomplete analysis report• Come-backs, further requests• Delays• Frustration• Accusations
Requests vs NeedsRequests vs Needs
• Know the Regulations• Liaise with the laboratory• Agree on what will be done• Obtain an analysis report as agreed• Plant nutrients in product• N P K Ca Mg S• Fe Mn Cu Zn Mo B Cl• Others Si Ni (Co Se …..)• Potentially Harmful Elements (PHEs)
• Know the Regulations• Liaise with the laboratory• Agree on what will be done• Obtain an analysis report as agreed• Plant nutrients in product• N P K Ca Mg S• Fe Mn Cu Zn Mo B Cl• Others Si Ni (Co Se …..)• Potentially Harmful Elements (PHEs)
Guiding / AdvisingWorking TogetherGuiding / AdvisingWorking Together
• Chemically compounded solid, liquid, foliar and horticultural fertilizers and liming material: Cd, Cr, Cu, Hg, Ni, Pb, Zn, As, Se
• Dry sewage sludge: above, as well as Co, Mo, B and F
• Chemically compounded solid, liquid, foliar and horticultural fertilizers and liming material: Cd, Cr, Cu, Hg, Ni, Pb, Zn, As, Se
• Dry sewage sludge: above, as well as Co, Mo, B and F
Table 12: PHEsTable 12: PHEs
• Complete, meaningful reports• Quality control. Check and re-check• Analytes within specs. Otherwise rejected!• Reanalysis?!• Rounding off. Realistic• Oxides: P, K, Ca, Mg (P2O5, K2O, CaO, MgO). Give elemental values
as well. Correct conversions• Units: g/kg or mg/kg on lables
(1000 mg/kg, rather use 1 g/kg)
• Complete, meaningful reports• Quality control. Check and re-check• Analytes within specs. Otherwise rejected!• Reanalysis?!• Rounding off. Realistic• Oxides: P, K, Ca, Mg (P2O5, K2O, CaO, MgO). Give elemental values
as well. Correct conversions• Units: g/kg or mg/kg on lables
(1000 mg/kg, rather use 1 g/kg)
General ChallengesWith Analysis ReportsGeneral ChallengesWith Analysis Reports
• Background• Quality of Applications• Analyses: COAs, PHEs• Formulations
• Background• Quality of Applications• Analyses: COAs, PHEs• Formulations
Backlog Project at DAFF: Realization
Backlog Project at DAFF: Realization
• Companies gave permission for “outsiders” to work on their application
• Commenced April 2016. Applications from August 2015• Soon realized – DAFF was right. The quality of applications was
appalling.• Considerable progress has been made however• Now cleared until July 2017• However, overlap still persists
• Companies gave permission for “outsiders” to work on their application
• Commenced April 2016. Applications from August 2015• Soon realized – DAFF was right. The quality of applications was
appalling.• Considerable progress has been made however• Now cleared until July 2017• However, overlap still persists
BackgroundBackground
Year Total Received Still with Fertasa Still with DAFF Registrations Finalized2014 283 - 8 1 2742015 141 2 4 1352016 244 8 28 2082017 92 28 12 52
Applications Submitted Through Fertasa
Applications Submitted Through Fertasa
Delays at Fertasa:• Waiting for additional information• More recent applications, waiting for
payment
General Comments on Applications
General Comments on Applications
• Applicant determines quality of application• Experience, qualification, ability• General lack of technical ability and insight. Why?• Economizing? Not the place • Luxury?• Completing Applications• Understanding, appreciating the function
and functionality of product range
• Applicant determines quality of application• Experience, qualification, ability• General lack of technical ability and insight. Why?• Economizing? Not the place • Luxury?• Completing Applications• Understanding, appreciating the function
and functionality of product range
General Comments on Applications Continued…
General Comments on Applications Continued…
• Consultants?• DAFF spends too much time coaching, teaching and pampering
applicants – Understanding situations• Original applications and corrections• This takes up too much time and delays
everything
• Consultants?• DAFF spends too much time coaching, teaching and pampering
applicants – Understanding situations• Original applications and corrections• This takes up too much time and delays
everything
Group 3 ApplicationsGroup 3 Applications
• Guidelines of February 2016• Clear?• Being revised – Group 3 Committee• Given to Registrar, inputs still awaited• Distinguish between fertilizers and agricultural remedies• Especially bio-fertilizers and bio-remedies• Detailed requirements for “report” required with
applications
• Guidelines of February 2016• Clear?• Being revised – Group 3 Committee• Given to Registrar, inputs still awaited• Distinguish between fertilizers and agricultural remedies• Especially bio-fertilizers and bio-remedies• Detailed requirements for “report” required with
applications
Group 3 ApplicationsContinued …
Group 3 ApplicationsContinued …
• Prior approval of trial protocol should be obtained• Revised guidelines will still be circulated for comments• Number of challenges with Group 3• What is a Group 3 product?• A product that has an added, or a novel, or an innovative
contribution to growth or soil properties. This needs to be identified, stated, justified and proven
• Prior approval of trial protocol should be obtained• Revised guidelines will still be circulated for comments• Number of challenges with Group 3• What is a Group 3 product?• A product that has an added, or a novel, or an innovative
contribution to growth or soil properties. This needs to be identified, stated, justified and proven
Group 3 ApplicationsContinued …
Group 3 ApplicationsContinued …
• Growth related trials (and claims). Glasshouse, orchard, field in a responsible, logical, statistical, scientific investigation at an acceptable organization by a recognised Scientist. Prove efficacy and non-phytotoxicity
• Soil improvement related products should be non-phytotoxic and do what they claim to do specifically, not generically. Could include appropriate laboratory investigations
• Growth related trials (and claims). Glasshouse, orchard, field in a responsible, logical, statistical, scientific investigation at an acceptable organization by a recognised Scientist. Prove efficacy and non-phytotoxicity
• Soil improvement related products should be non-phytotoxic and do what they claim to do specifically, not generically. Could include appropriate laboratory investigations
Group 3 ApplicationsContinued …
Group 3 ApplicationsContinued …
• Onus on applicant• Determine what they consider, with their scientific training or
support, conscience and credibility, should be adequate to prove what they know, or feel, or hope, or wish their product can do
• State it and prove it and put it on the label, sell it, have no come-backs, beat the opposition, and sleep at night
• If unsure, submit a formal protocol to the registrar prior to commencing
• Onus on applicant• Determine what they consider, with their scientific training or
support, conscience and credibility, should be adequate to prove what they know, or feel, or hope, or wish their product can do
• State it and prove it and put it on the label, sell it, have no come-backs, beat the opposition, and sleep at night
• If unsure, submit a formal protocol to the registrar prior to commencing
Group 3 ApplicationsContinued …
Group 3 ApplicationsContinued …
• Don’t ask individuals for their opinions. This can, and is causing considerable problems, dissatisfaction and confusion
• Don’t ask individuals for their opinions. This can, and is causing considerable problems, dissatisfaction and confusion
ConclusionConclusion
• Fertasa, as the recognised industry organization is ready to assist where it can. We advise, we discuss, we have Symposiums and Workshops to meet identified needs. Preferably join us and then, as a team, we can address the challenges. That is what we can offer.
• Please do your share as well.
• Fertasa, as the recognised industry organization is ready to assist where it can. We advise, we discuss, we have Symposiums and Workshops to meet identified needs. Preferably join us and then, as a team, we can address the challenges. That is what we can offer.
• Please do your share as well.
Thank YouThank You