EUROPAM, Version August 1998
in: Zeitschrift für Arznei- & Gewürzpflanzen 1998; 3:166-174 © Hippokrates Verlag GmbH, Stuttgart

0.2 Those farmers involved in the production of medicinal and aromatic plants should ensure that damage to the existing wildlife habitats is avoided and that efforts are made to maintain and enhance the biodiversity of their farms. It is advisable to regulate wild gathering 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 measures that are necessary in contributing to good product quality. In this respect, an attempt will be made to minimize insufficient quality by prevention means.

0.4 The main aim of GAP guidelines is to ensure that the plant raw material meets the demands of the consumer and thus fulfills high quality standards. It is therefore important that they:

• are produced hygienically, in order to reduce microbiological load to a minimum,
• are produced with care, so that negative effect on plants in the course of cultivation, processing and storage is limited.

Since medicinal and aromatic plants and their products are exposed to a large number of microbiological and other contaminants in the course of the production process, the main aim of the present guidelines is to provide guidance for producers to reduce this plant raw material contamination to the lowest possible minimum.

0.5 All participants in the production process (from primary producers to traders) are required to comply with these guidelines voluntarily and to develop practical measures in order to realize them.

Producers, traders and processors of medicinal and aromatic plants, especially of tea-related and herbal medicinal products, should comply with the GAP guidelines, document their products by a way bill (batch documentation) and demand that their partners also adhere to these requirements.

1.1 Seeds in use are to be identified botanically, indicating plant variety, cultivar, chemotype and origin1. The material used should be 100 % traceable. The same applies to vegetatively propagated parent material. Parent material used in organic production has to be certified as authentically organic.

1.2 The parent material should meet the requirements/standards concerning purity and germination (where available: certified seed/propagation material should be used). The parent material should be as free as possible from pests and diseases in order to guarantee healthy plant growth. If resistant or tolerant species or origins are available, they should be preferred.

1.3 The occurrence of plants and plant parts that are not species/variety identical has to be controlled in the course of the entire production process (cultivation, harvest, drying, packaging). Any impurites have to be eliminated promptly. Plant materials or seeds derived from or comprising genetically modified organsims have to comply with national and European Union regulations.

2. Cultivation

2.1 Depending on the method 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 should not be grown in soils that are contaminated by sludge. Furthermore, soils should not be contaminated by heavy metals, residues of plant protection products and any other unnatural chemicals. It should therefore be endeavoured to apply the use of chemical products with as minimum negative effect as possible.

2.2.2 The manure applied should be void of human faeces and be thoroughly composted prior to application.

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 Irrigation

2.3.1 Irrigation should be minimized as much as possible and only be applied according to the needs of the plant.

2.3.2 Water used for irrigation should comply with national and European Union quality standards and be as free as possible from 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 the growth and requirements of plants.

2.4.2 Pesticide and herbicide application shoud 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 have to be in conformity with the regulations of manufacturers and the respective national authorities.

The application should only be carried out 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 written form.

3. Harvest

3.1 Harvesting should take place when the plants are of best possible quality, according to their different utilizations.

3.2 Harvesting should preferably take place under the best possible conditions (wet soils, dew, rain or exceptionally high air humidity can be unfavourable). If harvesting is done under wet conditions, extra care should be taken in order to avoid the unfavourable influence of moisture.

3.3 Equipment should be kept in clean and technically perfect working condition. Those machine parts, including their housing, that have direct contact with the harvested crop should be regularly cleaned and kept free of oil and other contaminants (including plant left-overs).

3.4 Cutting devices of harvesters must be adjusted so that their collection of soil particles is reduced to a minimum.

3.5 In the course of harvesting, care should be taken to ensure that no toxic weeds are mixed with the harvested crop.

3.6 Damaged and perished plant parts must be promptly sorted out.

3.7 All containers used in the harvest must be cleaned and kept free of the remnants of previous crops; containers not in use, must also be preserved in a dry condition, free of pests and inaccessible to mice/rodents as well as livestock and other domestic animals.

3.8 The harvested crop should not come into direct contact with the soil. It must be promptly collected and submitted to transport under dry and clean conditions (by use of sacks, baskets, trailers, containers, etc.).

3.9 Mechanical damage and compacting of the crop that may result in undesirable quality changes must be avoided. In this respect, attention must be paid in ensuring that

• the sacks are not overfilled,
• the stacking up of sacks does not result in thickening of the crop,
• the harvested crop is transported and kept in containers or bags in such a way that the occurence of heating up is prevented.

3.10 Delivery of freshly harvested plant material to the processing facility must occur as quickly as possible in order to prevent its heating up.

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 after harvest includes such processing steps as washing, freezing, distilling, drying, etc. All these processes, whether for food or medicinal use, must conform to European Union and other national regulations.

4.1 On arrival at the processing facility, the harvested crop has to be promptly unloaded and unpacked. Prior to processing the material should not be directly exposed to the sun (except where there is specific need e.g. distillation) and it must be protected from rainfall.

4.2 Buildings used in the processing of harvested crops must be clean, thoroughly aerated and should not be used for the housing of livestock.

4.3 Buildings should be so constructed as to provide protection for the harvested crop against birds, insects, rodents as well as domestic animals. In all storage (including packaging) 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 kept clean and 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 above the ground. Attempts must be made to achieve uniform drying of the crop so as 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 with direct exposure to sunlight should be avoided unless it is required for a particular plant.

4.8 All material must be sorted 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 handy, emptied and cleaned daily.

4.10 The dried product should be promptly packaged in order to protect it from and reduce the risk of pest attacks.

5. Packaging

5.1 After the repeated control and eventual elimination of low-quality materials and any foreign bodies, the product should be preferably packaged in new, clean and dry sacks, bags or chests. The label must be clear, permanently fixed and be made of non-toxic material. Information must conform with the European Union and national labelling regulations.

5.2 Packaging materials should be stored in a clean and dry place that is free of pests and inaccessible to livestock and other domestic animals. It must be guaranteed that no product contamination occurs as a result of using 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 guaranteed. Fresh products (except basil) should be stored between 1°C and 5°C while frozen products should be stored below –18°C (or below –20°C 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 should be protected, e.g. by wire netting.

6.3 It is recommended that the packaged dry crop be stored as follows:

• in buildings with concrete or similar easily cleanable floors,
• on pallets,
• with sufficient distance from the wall,
• with thorough separation from other crops to avoid cross-contamination
• and organic products must be stored separately.

6.4 In case of bulk delivery, it is important to ensure that the transportation conditions are dry. Furthermore, it is highly advisable to use aerated containers in order to reduce the risk of mould formation or fermentation. As a supplement, the use of other sufficiently aerated transport vehicles and other aerated facilities is recommended. Essential oil transportation must conform to the relevant and applicable regulations. In this respect, national and European Union regulations on transport have to be adhered to.

6.5 Fumigation against pest attack should only be carried out on necessity and must exclusively be administered by licensed personnel. Only registered chemicals should 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 in accordance with European Union or national regulations.

6.7 Whenever frozen storage or saturated steam is used for pest control, the humidity of the stored material must be controlled after each 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 position. They must be well serviced and cleaned regularly. Fertilizer and pesticide application machinery must be regularly calibrated.

7.3 Preferably, non-wooden equipment should be used unless tradition requires the use of wooden material. Whenever wooden equipment is used (e.g. pallets, racks, bunkers, etc.), care should be taken to avoid its direct contact with chemical and other contaminated/infected materials, so as to prevent the impurity of the plant material.

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 food hygienic principles of Codex Alimentarius as well as the European directive on Good Manufacturing Practice (GMP).

8.3 The personnel entrusted with the handling of plant material are required to exhibit a high degree of personal hygiene (including those personnel working in the fields) and should have received adequate training in their hygienic responsibilities.

The buildings where the plant processing is carried out have to be equipped with changing facilities as well as toilets and hand washing facilities, with respect to the relevant regulations.

8.4 Persons suffering from known infectious diseases transmittable via food, including diarrhoea, or being transmitters of such diseases, must be denied entry into areas where they may come into contact with the plant material, as per relevant regulations.

8.5 Persons with open wounds, inflammations and skininfections should be kept away from those areas where plant processing takes place, or have to wear appropriate protective 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 of medicinal and aromatic plant products should be ensured.

9. Documentation

9.1 All parent materials and processing steps, including the location of cultivation, have to be documented. Field records showing previous cropping and used inputs should be maintained by all growers.

9.2 All batches from coherent areas should be clearly and unmistakably labelled (e.g. by the application of a batch number). This should take place as early as possible.

9.3 Batches from different cultivation areas may 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 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 fumigation agents such as phosphin must be entered into batch documentation.

9.6 All processes and procedures that could bear any impact on the quality of the product must be entered into the batch documentation.

9.7 All agreements (production guidelines, contracts, etc.) between the producer and the buyer should be laid down in 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 guidelines. Minimal information included in the way bill should cover the geographical definition of growth place, the country of origin and the responsible producer.

9.8 Audit results should be documented in an audit report (i.e. copies of all documents, reference index, audit reports, analysis results) and be stored for a minimum of 10 years.

9.9 Any special circumstances during the growth period which may influence the chemical composition, e.g. extreme weather conditions or pests – particularly in the harvest period – must be documented.

10. Education

It is highly advisable to educate all personnel dealing with the crop or those engaged in the management of production, in production techniques as well as the appropriate use of herbicides and pesticides.

11. Quality Guarantee

Consultation 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, limited germ numbers, plant protection chemical residues and heavy metals, must be based on nternationally recognized or national specifications and should be laid down in written form.