Pesticide

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on: 
Thursday, April 18, 2024

REFERENCES ....................................................................................................................................... 14

Key Points: 
    • REFERENCES ....................................................................................................................................... 14

      29

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 3/14

      30

      EXECUTIVE SUMMARY

      31
      32
      33
      34
      35
      36

      This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

      37

      1.

    • Due to the inherent
      complexity of medicinal plants and herbal substances the quality of these starting materials requires an
      adequate quality assurance system for the collection and/or cultivation, harvest, and primary
      processing.
    • (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
      types could have several problems and advantages.
    • The used cultivation method may be dependent on
      the final application of the herbal medicinal product.
    • primary processing of herbal substances that are used for the preparation of herbal medicinal products.
    • medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
      stages of cultivation, collection, processing and storage.
    • their preparations are exposed to a large number of environmental contaminants of both biotic and
      abiotic origin.
    • to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
      Endangered species of Wild Fauna and Flora).
    • https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
      4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
      3

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 5/14

      104

      4.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 6/14

      147
      148
      149

      8.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 7/14

      185

      7.

    • Where possible, stable varieties and cultivars naturally
      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 8/14

      227
      228

      resistant or tolerant to disease should preferably be used.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 9/14

      268
      269
      270
      271
      272
      273

      The application should be carried out only by qualified staff using approved equipment.

    • The following should be noted:

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 10/14

      309
      310

      ?

      311
      312
      313

      ?

      314
      315
      316
      317

      ?

      318
      319
      320

      ?

      321
      322

      ?

      323
      324
      325

      ?

      326
      327
      328

      ?

      Damaged plants or plant parts need to be excluded or limited in accordance with a specific
      pharmacopoeia monograph, where relevant.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 11/14

      347
      348

      directly to the sun (except in cases where there is a specific need) and must be protected from
      rainfall, insect infestation, etc.

    • The label must be clear, permanently fixed and made from

      6

      Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 12/14

      386
      387

      non-toxic material.

    • Certain exudates that have not been subjected to a specific treatment are

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 13/14

      425
      426
      427

      also considered to be herbal substances.

    • European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433

      Are obtained by subjecting herbal substances to treatments such as
      extraction, distillation, expression, fractionation, purification, concentration
      or fermentation.

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on: 
Thursday, April 18, 2024

REFERENCES ....................................................................................................................................... 14

Key Points: 
    • REFERENCES ....................................................................................................................................... 14

      29

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 3/14

      30

      EXECUTIVE SUMMARY

      31
      32
      33
      34
      35
      36

      This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

      37

      1.

    • Due to the inherent
      complexity of medicinal plants and herbal substances the quality of these starting materials requires an
      adequate quality assurance system for the collection and/or cultivation, harvest, and primary
      processing.
    • (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
      types could have several problems and advantages.
    • The used cultivation method may be dependent on
      the final application of the herbal medicinal product.
    • primary processing of herbal substances that are used for the preparation of herbal medicinal products.
    • medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
      stages of cultivation, collection, processing and storage.
    • their preparations are exposed to a large number of environmental contaminants of both biotic and
      abiotic origin.
    • to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
      Endangered species of Wild Fauna and Flora).
    • https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
      4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
      3

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 5/14

      104

      4.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 6/14

      147
      148
      149

      8.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 7/14

      185

      7.

    • Where possible, stable varieties and cultivars naturally
      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 8/14

      227
      228

      resistant or tolerant to disease should preferably be used.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 9/14

      268
      269
      270
      271
      272
      273

      The application should be carried out only by qualified staff using approved equipment.

    • The following should be noted:

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 10/14

      309
      310

      ?

      311
      312
      313

      ?

      314
      315
      316
      317

      ?

      318
      319
      320

      ?

      321
      322

      ?

      323
      324
      325

      ?

      326
      327
      328

      ?

      Damaged plants or plant parts need to be excluded or limited in accordance with a specific
      pharmacopoeia monograph, where relevant.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 11/14

      347
      348

      directly to the sun (except in cases where there is a specific need) and must be protected from
      rainfall, insect infestation, etc.

    • The label must be clear, permanently fixed and made from

      6

      Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 12/14

      386
      387

      non-toxic material.

    • Certain exudates that have not been subjected to a specific treatment are

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 13/14

      425
      426
      427

      also considered to be herbal substances.

    • European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433

      Are obtained by subjecting herbal substances to treatments such as
      extraction, distillation, expression, fractionation, purification, concentration
      or fermentation.

Else Nutrition Announces Highly Anticipated First Commercial Launch of its Groundbreaking Plant-Based Infant Formula in Australia; Also Targeting $50B (USD) Plus Asia Pacific Baby & Child Nutrition Markets

Retrieved on: 
Tuesday, April 2, 2024

VANCOUVER, British Columbia, April 02, 2024 (GLOBE NEWSWIRE) -- ELSE NUTRITION HOLDINGS INC. (BABY) (BABYF) (0YL.F) (“Else” or the “Company”) is proud to announce the official commercial launch of its first-in-class ‘Follow-On’ formula for infants ages 6-12 months in Australia. The commercial launch of the Follow-On formula for infants in Australia is a significant milestone as it marks the first country, along with New Zealand, in which the Company’s new infant formula is eligible for sale. In addition, the Company announces the launch of its Toddler Drink for toddlers ages 12-36 months in Australia.

Key Points: 
  • In addition, the Company announces the launch of its Toddler Drink for toddlers ages 12-36 months in Australia.
  • According to Research and Markets , the Asia Pacific (APAC) baby, infant and toddler food market is expected to grow from an estimated market size of US$50 billion in 2021 to over US$75 billion in 2028.
  • Else's plant-based infant formula also addresses consumer concerns about processed ingredients, major allergens, and potential residues found in standard dairy-based formulas.
  • Else’s infant formula is free of antibiotics, hormones, pesticides, GMOs, and heavy metals – all of which are an increasing concern among parents.

Zimbabwe Agri-business Industry Report 2023: Local and International Influences, Competitive Environment, Outlook, Industry Associations - ResearchAndMarkets.com

Retrieved on: 
Monday, April 8, 2024

The "The Agri-business Sector in Zimbabwe 2023" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "The Agri-business Sector in Zimbabwe 2023" report has been added to ResearchAndMarkets.com's offering.
  • The agribusiness industry is one of Zimbabwe's most important economic growth drivers together with mining and tourism.
  • All farm land belongs to the state and farmers are issued with 99-year lease agreements.
  • Zimbabwe's GDP growth is projected at 3.2% in 2023 up from 3.0% in 2022, anchored by agriculture, mining, and services.

Environmental Remediation Market to Reach $218.8 billion, Globally, by 2032 at 7.1% CAGR: Allied Market Research

Retrieved on: 
Monday, April 8, 2024

PORTLAND, Ore., April 8, 2024 /PRNewswire/ -- Allied Market Research published a report, titled, "Environmental Remediation Market by Site-Type (Public and Private), Medium (Soil and Groundwater), Technology (Air Sparging, Soil Washing, Chemical Treatment, Bioremediation, Electrokinetic Remediation, Excavation, and Permeable Reactive Barriers), and Application (Mining & Forestry, Oil & Gas, Agriculture, Automotive, Landfills and Waste Disposal Sites, Manufacturing, Industrial, and Chemical Production/Processing, Construction and Land Development, Others): Global Opportunity Analysis and Industry Forecast, 2023-2032". According to the report, the "environmental remediation market" was valued at $110.7 billion in 2022, and is estimated to reach $218.8 billion by 2032, growing at a CAGR of 7.1% from 2023 to 2032.

Key Points: 
  • The Russia-Ukraine war had significant implications on the environmental remediation market, affecting both the demand for remediation services and the resources available for environmental cleanup efforts.
  • As a result, there is an increased need for environmental remediation services to address these pollution incidents and mitigate their impacts.
  • Geopolitical tensions and economic sanctions stemming from the Russia-Ukraine war impact international cooperation and investment in environmental remediation initiatives.
  • Collaboration between countries and organizations on transboundary pollution issues and environmental cleanup projects are expected to be strained, leading to delays or disruptions in remediation efforts.

Environmental Remediation Market to Reach $218.8 billion, Globally, by 2032 at 7.1% CAGR: Allied Market Research

Retrieved on: 
Monday, April 8, 2024

PORTLAND, Ore., April 8, 2024 /PRNewswire/ -- Allied Market Research published a report, titled, "Environmental Remediation Market by Site-Type (Public and Private), Medium (Soil and Groundwater), Technology (Air Sparging, Soil Washing, Chemical Treatment, Bioremediation, Electrokinetic Remediation, Excavation, and Permeable Reactive Barriers), and Application (Mining & Forestry, Oil & Gas, Agriculture, Automotive, Landfills and Waste Disposal Sites, Manufacturing, Industrial, and Chemical Production/Processing, Construction and Land Development, Others): Global Opportunity Analysis and Industry Forecast, 2023-2032". According to the report, the "environmental remediation market" was valued at $110.7 billion in 2022, and is estimated to reach $218.8 billion by 2032, growing at a CAGR of 7.1% from 2023 to 2032.

Key Points: 
  • The Russia-Ukraine war had significant implications on the environmental remediation market, affecting both the demand for remediation services and the resources available for environmental cleanup efforts.
  • As a result, there is an increased need for environmental remediation services to address these pollution incidents and mitigate their impacts.
  • Geopolitical tensions and economic sanctions stemming from the Russia-Ukraine war impact international cooperation and investment in environmental remediation initiatives.
  • Collaboration between countries and organizations on transboundary pollution issues and environmental cleanup projects are expected to be strained, leading to delays or disruptions in remediation efforts.

Pet flea and tick treatments contain pesticides that end up washing into the environment - here’s how

Retrieved on: 
Tuesday, April 9, 2024

However, these treatments are polluting our rivers and could pose a health risk to pet-loving families, according to new research.

Key Points: 
  • However, these treatments are polluting our rivers and could pose a health risk to pet-loving families, according to new research.
  • They spread over the skin of the animal making it toxic to fleas (and sometimes ticks) for at least one month.
  • They’re often sold as part of a pet healthcare plan, whereby pet owners make a monthly payment for a package of year-round treatments.
  • There were multiple likely additional pathways for these chemicals to end up going down the drain.
  • In my opinion, preventative flea treatment is neither necessary nor desirable in most cases.
  • Non-chemical methods such as flea traps, regular hot washing of the animal’s bedding to kill larval fleas and hoovering are effective.
  • There are also oral flea and tick treatments such as isoxazolines, which rapidly resolve flea infestations.

Proceed with precaution

  • To make sure newer classes of parasiticide such as isoxazolines remain as effective as possible, extensive preventative use cannot continue.
  • Previous research has also raised concerns about possible health risks to pet owners and veterinary professionals from chronic exposure to pet parasiticides.
  • Our work supports these concerns, demonstrating that fipronil and imidacloprid readily transfer to bedding and owner’s hands, so they will quickly get smeared around the household.


Dave Goulson receives funding from the Veterinary Medicines Directorate. He is a member of the Green Party.

N2OFF: Save Foods Increasing its Potential Market Reach Following Pre-Harvest Regulatory Approval in California

Retrieved on: 
Monday, March 25, 2024

Neve Yarak, Israel, March 25, 2024 (GLOBE NEWSWIRE) -- N2OFF, Inc. (NASDAQ: NITO) (FSE:80W) (“N2OFF” or the “Company”), a pioneer agri-food tech company offering sustainable solutions for agriculture and plant-based food, previously announced that the California Department of Pesticide Regulation (CDPR) registered for use Save Foods Ltd.’s pre-harvest treatment, FieldProtect, based on its compliance with California laws and regulations pertaining to pesticide registration.

Key Points: 
  • The approval now extends the use of the product in California from exclusively post-harvest processes to include pre-harvest applications, which significantly broadens Save Foods' potential market reach.
  • We believe this marks an important step forward for Save Foods in providing food safety and reducing waste from field to fork, paving the way for its potential commercial expansion in California.
  • The Company believes entry into the California agricultural sector, which generates substantial revenue and leads in organic production in the United States, places Save Foods in a favorable position within the sustainable agriculture market.
  • Previous trial on strawberries, revealed promising results whereby Save Foods’ research and development team managed to dramatically extend the shelf life of strawberries.

Organic's best honored at "An Organic Night Out"

Retrieved on: 
Thursday, March 14, 2024

Hosted by The Organic Center and Organic Voices, “An Organic Night Out” showcased honorees in eight categories – all nominated and chosen by their peers.

Key Points: 
  • Hosted by The Organic Center and Organic Voices, “An Organic Night Out” showcased honorees in eight categories – all nominated and chosen by their peers.
  • “We’re honored to accept this award from The Organic Center and Organic Voices,” states Paul Lightfoot, General Manager of Patagonia Provisions.
  • It promotes their holiday offerings through an “Organic menu,” puts together organic cheese boards for its shoppers and helps them choose the best organic wines.
  • "The growth of organic doesn't happen in a vacuum; it takes the commitment and hard work of organic farmers, businesses and researchers to advance organic."

Progress Over Easy: Vital Farms Celebrates Continued Improvements to the Lives of People, Animals, and the Planet in 2024 Impact Update

Retrieved on: 
Thursday, March 14, 2024

“Our impact efforts reinforce our continued practice of working with all our stakeholders toward positive, long-term outcomes.

Key Points: 
  • “Our impact efforts reinforce our continued practice of working with all our stakeholders toward positive, long-term outcomes.
  • This year’s highlights include that Vital Farms:
    Achieved its goal of zero-waste-to-landfill at Vital Farms’ egg washing and processing facility, Egg Central Station (ECS) in Springfield, MO.
  • The company is working to engage 100% of its farmer network in additional regenerative principles by the end of 2026.
  • You can read the 2024 Impact Update including accomplishments, progress on Impact Goals, and standards-based metrics and disclosures here: www.vitalfarms.com/impact