EUROPAM the European Herb Growers Association
GAP/GWP – Subcommittee
Brussels, 5th november, 2001
Europam working copy no.5
Guidelines for Good Agricultural Practice (GAP)
of Medicinal and Aromatic Plants*
First Europam version
Discussion in EMEA ad hoc working group
Comments by EMEA ad hoc working group EMEA/HMPWG/17/99 draft and 18/99 draft
Updated to Europam working copy no.1
Release for consultation by Europam
Deadline for comments
Release of Europam working copy no.2
Release of Europam working copy (no.3) no.4
Next review meeting working copy no.5 Februar 2002
Note: *It is acknowledged by the members of Europam that EHIA (The European Herbal Infusion Association) has contributed substantially to the establishment of the drafted GAP guidelines.
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Guidelines for Good Agricultural Practice (G.A.P.)
of Medicinal and Aromatic Plants
Europam working copy no. 5
0.1. Scope. The guidelines for the Good Agricultural Practice of Medicinal and Aromatic (Culinary) herbs is intended to apply to the growing and primary processing of all such plants traded and used in the European Union. Hence it applies to the production of all plant materials used in the food, feed, medicinal, flavouring and perfume industries. It also applies to all methods of production including organic production in accordance with the European regulations.
0.2. The Environment. Growers involved in the production of herbs must ensure that they avoid damage to existing wildlife habitats, and that they make efforts to maintain and to enhance the biodiversity of their farms. Wild crafting is regulated by a specific guideline Good Wild crafting Practice (GWP).
0.3. The present Good Agricultural Practice Guidelines provide additional standards for the production and processing of raw materials insofar as they mainly focus on identifying those critical production steps (measures) that are needed to comply with good quality. In this respect, it will be attempt to minimize insufficient quality by prevention. National regulations will over-ride the recommendations of this document.
0.4. A main aim is to ensure that the plant raw material meets the demands of the consumer and as such the standards of the highest quality. Especially important aspects are that they:
- are produced hygienically, in order to reduce microbiological load to a minimum,
- are produced with care, so that the negative impacts affecting plants during cultivation, processing and storage can be limited,
As in the course of the production process medicinal and aromatic plants and their products are exposed to a large number of both microbiological and other contaminants, the main aim of present guidelines is to provide guidance for producers to reduce plant (raw material) contamination to the greatest extent.
0.5 This document is recommended to be used in bilateral relationship between the supplier and the customer and the products documentation may be regarded as confidential but a certificate or waybill contains all information of the production process (from primary producers to traders) who are required to comply with these guidelines voluntarily and to elaborate practical measures in order to realize them.
Producers, traders and processors of medicinal and aromatic plants should comply with the GAP Guidelines, document this, by Way Bill (Records and/or labels) and demand that their partners also meet these requirements.
Principles and Guidelines for Good Agricultural Practice (G.A.P.)
1. Seeds and propagation material
1.1. Seeding materials are to be identified botanically, indicating plant variety, cultivar, chemotype and origin. The material used should be traceable. The same applies to vegetatively propagated starting material. Starting materials used in organic production has to be certified organic.
1.2. Starting material should meet the requirements/standards concerning purity and germination (wherever available: certified seed/propagation material should be used). The starting material should be as free as possible of pests and diseases in order to guarantee healthy plant growth. When resistant or tolerant species or origins are available, they should be preferred.
1.3. The occurrence of not species/variety-identical plants and parts of plants has to be controlled in the course of the entire production process (cultivation, harvest, drying, packaging). Such impurities have to be eliminated promptly. Plants material or seeds derived from or comprising Genetically Modified Organisms have to be in accordance with national and European regulations.
2.1. Depending on the mode of cultivation e.g. conventional or organic, growers should be allowed to follow different Standard Operating Procedures for cultivation (to be elaborated). In general, care should be taken to avoid environmental disturbances. The principles of good crop husbandry must be followed including an appropriate rotation of crops.
2.2. Soil and Fertilization
2.2.1. Medicinal and aromatic plants must not be grown in soils that are contaminated by sludge. Soils should not be contaminated by heavy metals and residues of plant protection products and other not naturally occurring chemicals, etc. For this reason, minimum effective chemical input should be achieved.
2.2.2. The manure applied should be void of human faeces and prior to application it should be thoroughly composted.
2.2.3. All other fertilizing agents should be applied sparingly and in accordance with the demands of the plant and the particular species (including application between harvests). The use of fertilizers should be in accordance with efforts to minimize leaching.
2.3.1. Irrigation should be minimized as much as possible and applied according to the needs of the plant.
2.3.2. Irrigation-water should be in accordance with national and potential European quality standards and should be as free as possible of contaminants, such as faeces, heavy metals, pesticides, herbicides and toxicologically hazardous substances.
2.4. Crop maintenance and plant protection
2.4.1. Tillage should be adapted to plant growth and requirements.
2.4.2. Pesticide and herbicide application should be avoided as far as possible. When necessary they should be carried out using the minimum effective rates of approved plant protection products. Products for chemical plant protection have to conform with the European Union's maximum residue limits (European Pharmacopoeia, European Directives, Codex Alimentarius). Application and storage of plant protection products has to be in accordance with the recommendations of manufacturers and regulations of the authorities.
The application should be carried out only by qualified staff using approved equipment. Application should precede the harvest by a period either defined by the buyer or indicated by the producer of the plant protection product.
The use of pesticides and herbicides has to be documented and made available to the buyer on request.
2.4.3. All measures regarding nutrient supply and chemical plant protection, should secure the marketability of the product. The buyer of the batch could be informed of the brand, quality and date of pesticide use in a written form.
3.1. The harvest should take place when the plants are of the best possible quality according to the different utilizations.
3.2. Harvest should preferably take place under the best possible conditions (wet soils, dew, rain or exceptionally high air humidity can be unfavourable). If harvest is performed under wet conditions, extra care should be taken in order to avoid the unfavourable influence of moisture.
3.3. Equipment should be in a both clean and technically perfect working order. Those machine parts including their housings that have a direct contact with the harvested crop, should be regularly cleaned and kept free of oil and other contamination (including plant left-overs).
3.4. Cutting devices of harvesters must be adjusted so that the collection of soil particles can be reduced to a minimum.
3.5. In the course of harvest, care should be taken to ensure that no toxic weeds can mix with the harvested crop.
3.6. Damaged and perished plant parts must be promptly eliminated.
3.7. All containers used in the harvest must be clean and must be kept free of the remnants of previous crops; containers out of use, must also be preserved in a dry condition, free of pests and inaccessible for mice/rodents as well as livestock and domestic animals.
3.8. The harvested crop should not be exposed to direct contact with the soil. It must be promptly collected and under dry, clean conditions (e.g. sacks, baskets, trailers and containers, etc.) submitted to transport, with the exception of windrowed and root products prior to washing.
3.9. Mechanical damage and compacting of the crop that would result in undesirable quality changes must be avoided. In this respect, attention must be paid to
- avoiding the overfilling of the sacks,
- the stacking up of sacks should not result in thickening of the crop,
- the harvested crop should be transported and kept in containers or bags in such way that the occurrence of heating is prevented.
3.10. Delivery of freshly harvested plant material must occur as quickly as possible to the processing facility in order to prevent heating.
3.11. The harvested crop must be protected from pests, mice/rodents and domestic animals. Pest control measures should be documented.
4. Primary processing
Primary processing includes steps of processing such as washing, freezing, distilling, drying, etc.. All these processes whether for food or medicinal use must conform to relevant European and national regulations.
4.1. Arriving at the processing facility the harvested crop has to be promptly unloaded and unpacked. Prior to processing the material should not be exposed directly to the sun (except in case there is a specific need e.g. for distillation) and if washing is not involved it must be protected from rainfall.
4.2. Buildings used in the processing of harvested crops must be clean, as well as thoroughly aerated and must never be used for housing livestock.
4.3. Buildings must be constructed so as to provide protection for the harvested crop against birds, insects, rodents as well as domestic animals. In all storage (including packaging stores) and processing areas suitable pest control measures such as baits and electric insect killing machines must be operated and maintained by professionally qualified staff or contractors.
4.4. Processing equipment must be maintained clean and must be regularly serviced.
4.5. In the case of natural open air drying, the crop must be spread out in a thin layer. In order to secure unlimited air circulation, the drying frames must be located at a sufficient distance from the ground. Attempts must be made to achieve uniform drying of the crop and as a consequence to avoid mould formation when drying with oil, the exhaust fumes must not be reused for drying. Direct drying should not be allowed except with butane, propane, or natural gas
4.6. Except in the case of natural open air drying, the conditions (e.g. temperature, duration, etc.) must be selected taking into consideration the type (e.g. root, leaf or flower) and active substance content (e.g. essential oils and others) of the crude drug to be produced.
Drying conditions should be documented.
4.7. Drying directly on the ground or under direct exposure to the sun-light should be avoided unless it is required for a particular plant.
4.8. All material must be inspected or sieved in order to eliminate sub-standard products and foreign bodies. Sieves must be maintained in a clean state and should be serviced regularly.
4.9. Clearly marked waste-bins should be kept ready, emptied daily and cleaned.
4.10. In order to protect it, to respect quality and to reduce the risk of contamination, the product should be promptly packaged.
5.1. After the repeated control and eventual elimination of low-quality materials and foreign bodies, the product should be packaged in clean and dry, preferably new sacks, bags or cases. The label must be clear, permanently fixed and made from non-toxic material. Information must conform with the European and national labelling regulations.
5.2. Packaging materials should be stored in a clean and dry place that has to be free of pests and inaccessible for livestock and domestic animals. It must be guaranteed that no contamination of the product takes place by the use of packaging material, particularly in the case of fibre bags.
5.3. Reusable packaging materials should be well cleaned and perfectly dried prior to their usage. It must be guaranteed that no contamination takes place by reusing bags.
6. Storage and Transport
6.1. Packaged dried materials and essential oils should be stored in a dry, well aerated building, in which the daily temperature fluctuations are limited and good aeration is given. Fresh products (except Basil) should be stored between 1o C and 5o C while frozen products should be stored below -18o C (or below -20o C for longer term storage). Essential oil storage must conform to the appropriate chemical storage and transport standards concerning risks and labelling requirements in accordance with national regulations and in particular EU Council Directive 94/55/EEC .
6.2. As a protection against pests, birds, rodents and domestic animals, the window and door openings are to be protected, e.g. by wire netting.
6.3. Bulk storage as well as the packaged dry crop must be stored appropriately:
- in buildings with concrete or similar easy to clean floors,
- on pallets,
- with a sufficient distance to the wall,
- thoroughly separated from other crops to avoid cross-contamination.
Organic products must be stored in accordance with national organic regulations and EU Directive 2092/91.
6.4. In the case of bulk transport, it is important to secure dry conditions and furthermore, in order to reduce the risk of mould formation or fermentation, it is extremely advisable to use aerated containers. As a substitute, the use of sufficiently aerated transport vehicles and other aerated facilities is recommended. Essential oil transport must conform to appropriate regulations. National and European regulations on transport have to be respected.
6.5. Fumigation against pest attack should be carried out only in the case of necessity and it must be carried out exclusively by licensed personnel. Only registered chemicals must be used. Any fumigation against pest attack should be reported in the documentation.
6.6. For fumigation of warehouses, only permitted substances should be used, according to European or national regulations.
6.7. When frozen storage or saturated steam is used for pest control, humidity of the material must be controlled after treatment.
7.1. Equipment used in plant cultivation and processing should be easy to clean, in order to eliminate the risk of contamination.
7.2. All machinery should be mounted in an easily accessible way. They must be well serviced and regularly cleaned. Fertilizer and pesticide application machinery must be regularly calibrated.
7.3. Preferably non-wooden equipment should be used unless tradition demands wooden material. When wooden equipment (such as e.g. pallets, hoppers, etc.) is used, it should not come into direct contact with chemicals and contaminated/infected materials, so that infection of the plant material can be prevented.
8. Personnel and Facilities
8.1. Personnel should receive adequate botanical education before performing tasks that require this knowledge.
8.2. All processing procedures should fully conform with both EU-Guidelines on Food Hygiene and the General Principles for food hygiene of Codex Alimentarius as well as the European Directive on Good Manufacturing Practice.
8.3. Personnel entrusted with the plant material should be required to have a high degree of personal hygiene (including personnel working in the fields) and have received adequate training regarding their hygiene responsibilities.
The buildings where the plant processing is carried out, have to be provided with changing facilities as well as toilets including hand washing facilities, according to the respective regulations.
8.4. Persons suffering from known infectious diseases transmittable via food, including diarrhoea, or being transmitters of such diseases, must be suspended from areas where they are in contact with the plant material, according to the respective regulations.
8.5. Persons with open wounds, inflammations and skin-infections should be suspended from the areas where the plant processing takes place, or have to wear appropriate protecting clothing or gloves, until their complete recuperation.
8.6. Personnel should be protected from contact with toxic or potentially allergenic plant materials by means of adequate protective clothing.
8.7. The welfare of all staff involved in the growing and processing shall be ensured. Health regulations should be displayed in the working area.
9.1. All starting materials and processing steps have to be documented including the location of cultivation. Field Records showing previous cropping and inputs should be maintained by all growers.
9.2. All batches from coherent areas should be unambiguously and unmistakably labelled (e.g. by the application of a batch number). This should take place as early as possible and a Batch Packaging Record should be kept for each batch or part batch processed.
9.3. Batches from differing areas shall be mixed only if it is guaranteed that the mixture in itself will be homogenous. Such mixing procedures should also be documented by Batch Processing Records.
9.4. It is essential that Batch Processing Records include the type, quantity and the date of harvest of the crop, as well as the chemicals and other substances (e.g. fertilizers, pesticides and herbicides, growth regulators, etc.) used during production.
9.5. The application of the fumigation agents such as phosphin must be entered into batch processing records.
9.6. All processes and procedures that could bear an impact on the quality of the product must be entered into the Batch Processing Records and be available on request of the customer – required in the relation between producer and customer.
9.7. All agreements (production guidelines, contracts, etc.) between producer and buyer should be fixed in a written form.
It should be documented in a Record of Receipt (Way Bill) country of origin, producer and his address, botanical identification and part of the plant, batch number and date of production.
9.8. The results of audits should be documented in an Audit Report (copies of all documents, Schlagkartei, Audit Reports, Analyse Reports) to be stored for a minimum of 10 years.
9.9. Special circumstances during the growth period which may influence the chemical composition like extreme weather conditions, pests - particularly in the harvest period - must be documented in log books.
It is extremely advisable to educate all personnel dealing with the crop or those engaged in the direction of the production regarding production techniques and the appropriate use of herbicides and pesticides.
11. Quality Assurance
Agreements between producers and buyers of medicinal and aromatic plants, with regard to quality questions, e.g. active principles and other characteristic ingredients, optical and sensoric properties, limit values of germ numbers, plant protection chemical residues and heavy metals, must be based on internationally recognized or national specifications and should be laid down in a written
12. Self Inspection
Self inspection should be conducted in order to monitor the implementation and compliance with Good Agricultural Practice principles and to propose necessary corrective measures.
12.1 Personnel matters, premises, equipment, documentation, production, quality control distribution of herbal medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.
12.2 Self inspection should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts may be useful.
12.3 All self inspections should be recorded. Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures. Statements on the actions subsequently taken should also be recorded.