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

Retrieved on:

Thursday, April 18, 2024

Reproduction, SCOPE, Eating, Pesticide, Convention, Change control, Confusion, Alkaloid, Climate, Fungus, Directive (European Union), Ethylene oxide, Wind, Wood, Glass, European Medicines Agency, HMPS, QDG, Hygiene, Water, Marketing, Fertilizer, Legislation, Manure, Distillation, Risk, Education, Committee, Compost, Draft, Policy, Person, EMA, Seed, Polycyclic aromatic hydrocarbon, Collection, Freezing, GMP, Risk assessment, GACP, Sunlight, Fermentation, Personal protective equipment, Animal, Herbal, Herbicide, Weather, INTRODUCTION, Documentation, Regeneration, Decontamination, EudraLex, Disease, International trade, European Pharmacopoeia, Part, Livestock, Public, Inhalation, Knowledge, Seedling, Factorization of polynomials, Record, Plant, Skin, API, Irrigation, Part Two, Soil, Directive, Pharmacopoeia, Codex, Guideline, Temperature, Attention, Hydrocarbon, Pyrrolizidine alkaloid, Polychlorinated biphenyl, Growth, Rotation, Incineration, Environment, Humidity, Smell, Ventilation, Light, Bird, Mineral, Fumigation, Pyrrolizidine, SOP, Housing, Smoking, Atmosphere, Postharvest, Rain, Liver, QWP, Medicinal plants

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

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32
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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

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4.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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149

8.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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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
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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
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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

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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

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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.

New Survey Reveals Majority of Americans Agree, Cannabis Home Grow Should Be Legal

Retrieved on:

Tuesday, April 2, 2024

Alternative Medicine, Cannabis, Retail, Health, Tobacco, Natural Resources, Pharmaceutical, Seed, Legislation, Habit, Nature, Vegetable, RQS, Plant, F1, Seedling, The Harris Poll, Food, Safety, Drug

The 2024 survey of Americans 21 and older conducted online by The Harris Poll on behalf of Royal Queen Seeds (RQS), one of the world's largest and most trusted cannabis seed banks, shows that 59% of Americans agree that all Americans should have the right to legally grow cannabis at home.

Key Points:

The 2024 survey of Americans 21 and older conducted online by The Harris Poll on behalf of Royal Queen Seeds (RQS), one of the world's largest and most trusted cannabis seed banks, shows that 59% of Americans agree that all Americans should have the right to legally grow cannabis at home.
Findings suggest that home cultivation is as key to successful cannabis legalization legislation as regulated sales or record expungement.
The nationally representative study, conducted in February 2024, surveyed more than 2,000 adults ages 21 and older, among whom 713 are cannabis consumers.
Survey participants shared their thoughts on cannabis home grow laws as well as habits and purchasing patterns tied to 4/20, the largest cannabis sales day of the year.

Forest Service Awards American Forests $12M to Support Resilient Reforestation for Underserved Communities

Retrieved on:

Thursday, March 28, 2024

Carbon, IRA, Climate change, Organization, Disaster, Disease, PINE, American Forests, Climate, Seedling, Forest service, Biodiversity, Forestry, Inflation

PINE BLUFF, Ariz., March 28, 2024 /PRNewswire-PRWeb/ -- The USDA Forest Service has awarded American Forests $12 million to help tribes and underserved communities access financial and technical support for resilient reforestation.

Key Points:

PINE BLUFF, Ariz., March 28, 2024 /PRNewswire-PRWeb/ -- The USDA Forest Service has awarded American Forests $12 million to help tribes and underserved communities access financial and technical support for resilient reforestation.
Over the next three years, American Forests will collaborate with the Forest Service and numerous partners to make resilient reforestation more affordable and accessible for underserved landowners, including federally recognized tribes and Native Hawaiian organizations.
Through the award, American Forests and partnering organizations will help forest owners participate in emerging private markets for resilient reforestation.
Funded by the Inflation Reduction Act, the program is investing $145 million in organizations that support underserved and small-acreage forest owners.

Powering Drones to Full Capacity for Spring Farming in Xuzhou, Jiangsu

Retrieved on:

Monday, March 25, 2024

Crop protection, Party, Electricity, Pesticide, Farmer, Seedling, Plant, Agriculture

In the local wheat fields, a new type of drone carrying pesticides is also being efficiently utilized to combat pests among wheat seedlings.

Key Points:

In the local wheat fields, a new type of drone carrying pesticides is also being efficiently utilized to combat pests among wheat seedlings.
To ensure the uninterrupted operation of the agricultural drones, the State Grid Xuzhou Power Supply Company has deployed mobile charging stations to the fields.
"During the spring plowing and irrigation season, we have repurposed repair vehicles into mobile charging stations to assist farmers in their drone battery charging.
A dedicated team has been established to conduct targeted inspections on low-voltage irrigation lines and equipment used for spring irrigation electricity services.

MDWerks Highlights the Environmental Sustainability Advantages of its Energy Wave Technology Solutions in the Alcoholic Beverages and Industrial Sectors

Retrieved on:

Thursday, March 7, 2024

Steven Laker, CEO of MDWerks, commented, “As companies increasingly look to reduce their carbon footprints and enhance efficiency, MDWerks is well positioned to disrupt both the alcoholic beverages and industrial sectors with its sustainable energy wave technology.

Key Points:

Steven Laker, CEO of MDWerks, commented, “As companies increasingly look to reduce their carbon footprints and enhance efficiency, MDWerks is well positioned to disrupt both the alcoholic beverages and industrial sectors with its sustainable energy wave technology.
Key benefits of Sustainably Matured™ technology:
RFS utilizes proprietary energy wave technology alongside its patented and proprietary molecular targeting technology to provide sustainable manufacturing solutions to industrial customers in the engineered wood, structural wood, and adhesives space.
Utilizing its energy wave expertise, RFS designs and builds custom manufacturing equipment that enables more efficient production lines, thereby driving greater environmental sustainability.
If you would like to learn more about how our solutions can improve your company’s environmental sustainability and add value to your business, please contact us on our website at https://www.rfspecialtiesus.com/contact/ .

BIO-CAPSULE TECHNOLOGY™ "...could make liquid seed treatment obsolete."

Retrieved on:

Tuesday, February 27, 2024

Innovation, Capsule, Soybean, Meristem, Farmer, Metalaxyl, Polymer, Commodity, Seedling, EPA, Research, Agriculture

HOUSTON, Feb. 27, 2024 /PRNewswire/ -- Commodity Classic -- Meristem Crop Performance today announced the U.S. Environmental Protection Agency (EPA) has approved a new formulation of METALAXYL ST fungicide for use in their patented BIO-CAPSULE TECHNOLOGY™ complete seed-fluency delivery system. The company will now pair METALAXYL ST with its new biocontrol PREPHYTE ST** to bring multiple modes of action and more effective seed protection to soybeans, eliminating the need for liquids and seed treaters.

Key Points:

Eviston also explained that polymers and colorants used in traditional liquid seed treatments actually decrease the efficacy of the materials applied, something use of the BIO-CAPSULE system avoids entirely.
"Independent, third-party research has documented that the BIO-CAPSULE puts 10-times the live microbes and other active ingredients on the seed when compared with conventional seed treatment or what can be applied through liquid on the planter.
This could make liquid seed treatment obsolete."
"There's been no significant innovation in seed treatment or seed protection for 30 years," he said.

Hokkaido University develops theoretical models of tree masting

Retrieved on:

Monday, February 26, 2024

SAPPORO, Japan, Feb. 26, 2024 /PRNewswire/ -- The effects of a phenomenon called tree masting on ecosystems and food webs can be better understood thanks to new theoretical models validated by real world observations.

Key Points:

Joint press release by Hokkaido University and the National Institute for Environmental Studies.
SAPPORO, Japan, Feb. 26, 2024 /PRNewswire/ -- The effects of a phenomenon called tree masting on ecosystems and food webs can be better understood thanks to new theoretical models validated by real world observations.
Researchers at Hokkaido University have developed new computer-based models of masting that, amongst other uses, could help predict the effects of climate change on woodland and forests.
Végh and Kato developed four models of masting using combinations of three major masting theories, which cover the trees' resource budget, pollen limitation and exposure to weather patterns.

Hokkaido University develops theoretical models of tree masting

Retrieved on:

Monday, February 26, 2024

SAPPORO, Japan, Feb. 26, 2024 /PRNewswire/ -- The effects of a phenomenon called tree masting on ecosystems and food webs can be better understood thanks to new theoretical models validated by real world observations.

Key Points:

Joint press release by Hokkaido University and the National Institute for Environmental Studies.
SAPPORO, Japan, Feb. 26, 2024 /PRNewswire/ -- The effects of a phenomenon called tree masting on ecosystems and food webs can be better understood thanks to new theoretical models validated by real world observations.
Researchers at Hokkaido University have developed new computer-based models of masting that, amongst other uses, could help predict the effects of climate change on woodland and forests.
Végh and Kato developed four models of masting using combinations of three major masting theories, which cover the trees' resource budget, pollen limitation and exposure to weather patterns.

Flowers grown floating on polluted waterways can help clean up nutrient runoff and turn a profit

Retrieved on:

Tuesday, February 13, 2024

Flowers grown on inexpensive floating platforms can help clean polluted waterways, over 12 weeks extracting 52% more phosphorus and 36% more nitrogen than the natural nitrogen cycle removes from untreated water, according to our new research.

Key Points:

Flowers grown on inexpensive floating platforms can help clean polluted waterways, over 12 weeks extracting 52% more phosphorus and 36% more nitrogen than the natural nitrogen cycle removes from untreated water, according to our new research.
In our trials of various flowers, giant marigolds stood out as the most successful, producing long, marketable stems and large blooms.
Why it matters
Water pollution is caused in large part by runoff from farms, urban lawns and even septic tanks.
Nutrient runoff is a critical issue as urban areas expand, affecting the health of water ecosystems.