5 August 1998
Final Europam Version
General Part
Introduction
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 might be regulated by a specific guideline.
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.
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. All participants of the production process (from primary producers to traders) 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, especially of tea-like products and herbal medicinal products, should comply with the GAP Guidelines, document this, by a Way Bill (batch documentation) 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 100 % traceable. The same applies to vegetatively propagated starting material. Starting material 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. Cultivation
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 cannot be grown in soils that are contaminated by sludge. Soils should furthermore not be contaminated by heavy metals, 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 feces 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 minimise leaching.
These specifications can vary, as follows:
a) Species: Chamomilla recutita Rauschert: cultivar: Bodegold: chemotype bisabololoxide A/Chamazulene. Origin: Seed Company. 1996. Charge No 4711
b) Species: Chamomilla recutita Rauschert: self-collected seed from the area in front of the ranch: Delightful Herbs. No. 5. Harvester Str., 91222 Chamomille Town. California. on 26.6.1991.: since that time propagated
2.3. Irrigation
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 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.
2.4.3. All measures regarding nutrient supply and chemical plant protection, should secure the marketability of the product. It is obligatory that the buyer of the batch be informed of the brand, quantity and date of pesticide use in a written form.
3. Harvest
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 a 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.
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 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 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 should 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 and to reduce the risk of pest attacks, the product should be promptly packaged.
5. Packaging
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 I 0C and 50C while frozen products should be stored below —180C (or below —200C for longer term storage). Essential oil storage must conform to the appropriate chemical storage standards.
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. It is recommended that the packaged dry crop will be stored:
- 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 separately.
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. Equipment
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 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.
9. Documentation
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.
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.
9.4. It is essential to document 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 documentation.
9.6. All processes and procedures that could bear an impact on the quality of the product must be entered into the batch documentation.
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 Way Bill (batch documentation) that cultivation, harvesting and production have been performed in accordance with the GAP Guideline. Minimum information included in the Way Bill should cover geographical definition of growth place, country of origin and responsible producer.
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.
10. Education
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 form.