6.8 Quality control

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Analytical techniques are sufficiently advanced to permit identification of pure, natural royal jelly and to reveal possible adulteration. They can also be used to determine the quantity of royal jelly used in combination with other products.

The analysis of royal jelly is generally based on the quantitative determination of the three principal categories of compounds (lipids, sugars and proteins), its water content and of other significant indices such as pH and total acidity. Lipids are the most important compounds in determining the authenticity or adulteration of royal jelly, since several of them are not found in any other natural products. The qualitative and quantitative analysis of the lipid fraction also makes it possible to determine the amount of royal jelly in a multi-component product (Pourtallier et al., 1990). Among the biologically active components, the vitamin content can give an indication of the corresponding (assumed biological) activity of royal jelly. The most important indicators and limits are presented in Table 6.5. For methods of analysis, the respective publications should be consulted. Apparently, there are no legally established standards or international agreements. Nakamura (1985) reports the standards required by the Japanese "Fair Competition" regulations and approved by the Fair Trade Commission of Japan (see Table 6.5).

In addition to scientific analysis, there are some simple tests that can be used to indicate whether royal jelly is of good quality. Royal jelly generally darkens with age due to oxidation, although some fresh royal jellies may already be quite dark. Experience makes it possible to distinguish the appearance, smell and taste of a well-preserved or fresh royal jelly from one that is neither. Other simple tests are listed below.

The appearance of a solution and the presence of exuviae (larval skin fragments):

1 g of royal jelly is diluted in approximately 20 ml of distilled water. An opalescent solution with suspended material results (Nakamura, 1985). Then a concentrated solution of caustic soda is added drop by drop until the solution becomes clear. The alkaline solution thus obtained is (more or less) dark yellow green, more rarely yellowish pink or pink (Chauvin and Louveaux, 1956). Fragments can be seen suspended in the liquid which may be decanted and filtered. Under a microscope, the filtered residues should be identifiable as larval exuviae or exuviae fragments.

Table 6.5

Quality control methods and proposed limits for pure, natural royal jelly

Boiling test

Royal jelly boiled with a small piece of potassium hydroxide will emit the smell of ammonia.

Mercury chloride reagent test

A white sediment is formed when the mercury chloride reagent solution is added.

Iodine solution test

A red-brown sediment is formed when the iodine solution is added (Nakamura, 1985).

Pollen analysis

Microscopic analysis of the pollen content can be used to determine the origin of the royal jelly. This is a simple procedure, but it requires a great deal of experience in determining the pollen species and interpreting the results (Chauvin and Louveaux, 1956 and Ricciardelli D'Albore and Bernardini, 1978).

6.9 Caution

No toxic effects have been observed in royal jelly for external use, as food or for injection. Allergic reactions however, as a result of contact or injection, may occur. As with all other potential allergenic substances, small quantities should be tried for a few days before using full doses. In case of allergic reactions, its use should be suspended immediately.

Since none of the claimed therapeutic or other effects of royal jelly have been proven with certainty, any advertising or package labelling should, for legal as well as ethical reasons, be truthful and should not raise unjustified consumer expectations. In the long-term this will improve consumer confidence and ultimately, sales.

From the production and organizational point of view, the temperatures to be maintained during storage are the most restricting factor. It is therefore essential that production and marketing are extremely well-planned and appropriate storage facilities are available at the producer, distributor and retail level.

6.10 Market outlook

No official market statistics are available, only estimates (Nardi, 1986). China is unanimously recognized as the world's largest producer and exporter of royal jelly. Its estimated annual production is in the order of 400 to 500 tons, nearly all exported to Japan, Europe and the USA. China accounts for approximately 60% of world production. Other countries in the Far East (Korea, Taiwan and Japan) are also important producers and/or exporters. In the rest of the world, royal jelly is produced mainly in Eastern Europe and,

At the time of writing (April 1993) the international wholesale price of royal jelly, based on that of China, the largest supplier, was US$ 50-80 per kg. Local prices in different countries can still vary considerably and be much higher (the price in Argentina in 1992 varied between US$ 100 and 180/kg). Comparing these figures to the one reported by Inoue and Inoue almost 30 years ago (1964, US$ 180 to 400 per kg, in various countries) there has clearly been an enormous drop in price in real terms. Even without international competition, the decline in price was already obvious by the late 1950's in countries where the use of royal jelly started. The greater availability worldwide (particularly due to increasing Asian production) and the fact that the properties of royal jelly have not yet been determined conclusively, are probably the two main reasons for this drop in price.

In its processed form as tablets, capsules or vials, the equivalent of 1 kg of royal jelly may cost the consumer of some products as much as US$ 3,300. The price margin is similar to that of dried and processed pollen.

Japan has probably the highest domestic consumption of royal jelly (180 tons, Inoue, 1986) a large part of which is imported from other Asian countries. Outside Asia, the main markets for royal jelly are in the European and North American cosmetics industry and to a lesser extent, in the health food market. If therapeutic and other beneficial properties of royal jelly can be established scientifically, this market for royal jelly products (see Figure 6.7) with all its "value added", has the potential to explode.

The Asian market is potentially very large and with proper marketing should have tremendous value. In Asia, consumer preferences and traditions differ from those prevailing in Europe and North America and have facilitated marketing and increased production. Local cosmetic industries in particular, have very great potential for growth once quality and marketing (most of all packaging) approach the levels of Western competitors. The use of royal jelly in cosmetics has led to some very successful products. In one case (in Thailand) a business originally based on cosmetics with royal jelly and other bee products was so successful that it grew into a multimillion dollar enterprise.

While these successful companies became large operations, there is still plenty of room for small, local businesses (beauty parlours, vendors, pharmacies and others) to formulate articles containing bee products and in particular, royal jelly. These need to be adapted and selected according to local consumer preferences and customs. The need for high quality packaging and intelligent marketing, cannot be over-emphasised.

To conclude, a statement by Inoue and Inoue (1964) which unfortunately is still valid after 30 years, can be quoted: "We believe that the demand for royal jelly will increase again if, and only if, a reliable therapeutic value for humans can be established by further scientific research, and as a result official recognition is obtained from the Ministry of Health". The same might be said for its "added value" products.

6.11 Recipes

The proportions of royal jelly in a dietary product are usually adjusted to provide a dose equivalent to 200 to 300 mg fresh weight of royal jelly. Preparations such as soft gel capsules (also called gelatin drops or pearls) and those with freeze-dried granules (juice concentrates) which require higher and more expensive technologies, are not usually manufactured by small enterprises, but hired out to large companies specializing in this kind of work.

While the composition of the products can be varied and different formulations be tested, selected formulas need to be precise to allow consistent product  quality between batches and the correct product consistency, where this is required.

The larger the production grows, the more important become hygiene, quality control, storage capacity and quick distribution and sale. Processes and ingredients may have to be adjusted slightly to accommodate larger scale production. Care should be taken however, not to alter or destroy the natural characteristics of the raw materials.

Certain types of packaging such as some automatic-mixing vials, blister packages for pills and capsules, and plastic and metal foil lined cartons or papers also require more expensive technology, but alternatives can be employed. For all preparations, the final presentation is very important. Unfortunately, presentation has sometimes become more important than the quality of the packaged product.

6.11.1 Freeze-dried (lyouhilised) royal iellvy

Freeze-dried royal jelly is a very hygroscopic powder. It is obtained by evaporating the water content from the frozen product in a vacuum. This is the drying process which best maintains the original characteristics of the product: it retains the volatile components which would be removed by evaporation at higher temperatures and does not damage nor denature the thermolabile components.

Freeze-drying requires special equipment, ranging from a simple laboratory freezedrier (see Figure 6.8) to large industrial plants (see Figure 6.9). Though the small laboratory models are normally used for analysis only, small volumes of royal jelly can be processed adequately with this size of equipment. Prices range from approximately US$ 10,000 for thc smallest drier system to several hundred thousand dollars for larger, industrial systems.

For drying, the royal jelly is first diluted with some clean water. This leads to a more regular and complete loss of water, particularly if large quantities are freeze dried in one batch. No such preparation is necessary if royal jelly is dried directly in the sales vial. During the final drying phase, in order to achieve more complete removal of residual water, the substrate can be warmed very slightly, but never above 35 ⁰C.

After freeze-drying, the royal jelly becomes extremely hygroscopic and must be protected from the humidity of the environment by storage in an airtight container. Larger processors handle freeze-dried royal jelly only in controlled atmospheres, i.e. air conditioned rooms with very low humidity. Depending on the final use of the dried royal jelly, a carrier base or stabilizer is added at this point, as described in section 6.7. This reduces the hygroscopicity of the dried product.

Freeze-dried royal jelly marketed directly to the consumer is usually presented in separate vials one or more for a liquid solvent and others containing the dry phase. This is the best solution for conservation without chemical preservatives. The liquid phase can be pasteurized and packed aseptically, without damaging the heat sensitive royal jelly (see also Figure 6.4).

Ingredients for one dose:

A typical package contains 10 glass vials with the sterilized water-honey solution. The dry phase is packed in separate, metal or gel capsules, which themselves are often packed in individual glass vials. If necessary, the proportion of stabilizing support can be increased to reach a volume or weight which is easier to process.

6.11.2 Honey with royal jelly

For this type of product both liquid and fast crystallizing honeys can be used. Preparation of creamed honeys with royal jelly is described in Chapter 2. If the moisture content of the honey is sufficiently low (<16%) there is no visible alteration even when the product is stored at room temperature, but there are no data available on the stability of the royal jelly components and in any case, consumers should be advised to store the mixture in a refrigerator (Contessi, 1990).

The honey must have a very low moisture content, since the added moisture of royal jelly (0.6 to 0.7 g of water per gram of royal jelly added) could cause the honey to ferment. If, for example, 3 % of royal jelly is mixed with the honey an additional 2% of moisture is added. To avoid such a problem, freeze-dried royal jelly could be used instead. Moreover, in honeys that are not dense, e.g. those with a higher moisture content, the royal jelly tends to separate from the honey and rise to the surface. The honey and royal jelly mix can be packaged in the same way as pure honey, since it has the same physical characteristics, but it is preferable to package it so as to differentiate it visually from pure honey (in a glass jar or bottle of different colour or shape, or in a tube or straw with an additional carton etc).

To prepare the mixture, the procedure described in section 5.16.4 is used, i.e. the royal jelly is blended into a small amount of honey and this pre-mix is then stirred into the rest of the honey. Royal jelly may be added to creamed honey before crystallization.

Similar honey-based products can be prepared by adding other products of the hive (pollen and/or propolis extract). In these cases, physically stable products are obtained only when crystallized (creamed) honey is used.

6.11.3 Yoghurt with royal lelly

Yoghurt, like royal jelly, has a low pH and requires cold storage, so a minimum of problems are encountered in storing and selling mixtures. A commonly used mixture is 2 g of royal jelly per kilogramme of yogurt, so that in a standard 125 g jar (one serving) there are 250 mg of royal jelly. Royal jelly is added to the yoghurt after fermentation and is thoroughly blended by homogenization. Except for industrial homogenizers, homogenization is best achieved by making a small pre-mix, followed by final blending of thc pre-mix with the whole batch.

6.11.4 Jellies and soft caramels

Ingredients (in parts by weight):

The pectin should be dissolved in cold water before boiling it (see also sections 2.12.13 and 2.12.18). The ratio between sugars and honey can be varied, according to cost, flavour or other considerations. The total water content ranges between 20 to 25% and the quantity of pectin or other gum determines the final consistency. To the above base recipe, a number of other, aromatic agents can be added, such as fruit puree, essential oils and plant extracts.

These gelatinous caramels can be produced manually by pouring the solidijying jelly onto a flat table or metal tray or into moulds of different shapes. The royal jelly should be added just prior to the pouring at a temperature as low as possible. Once cooled and semi-hardened, small cubes are cut out and covered with fine sugar crystals or powdered (icing) sugar. The cubes are then individually heat-sealed into clear plastic bags or packed in clear plastic boxes and labelled. Similar formulas are marketed by various producers.

6.11.5 Liquid preparations

The following four products were selected as examples because of their form of marketing, as well as their distinct, but typical formulation. Packaging is often in small (single) doses, which is fairly expensive and may require special bottling equipment. Separation of the dry and liquid phases is partly for better conservation of the active ingredients, but probably just as important, it makes for special consumer appeal. Presenting it in this new form as if it were a medicine and requiring the consumer to actively participate by "mixing his/her own preparation" creates an important appeal for some markets and adds to ever increasing product diversity in what has become a highly competitive market.

Even considering the expensive packaging this is a very popular and profitable form of marketing royal jelly. Since these products only form a very small market, very little official quality control is exercised and consumer confidence is easily misused. Frequently, though not stated in formulations or ingredient lists, preservatives such as ascorbic acid or alcohol are added. The liquid phase always presents a preservation problem.

1) Ingredients for one dose:

A typical package contains ten 10 ml dark glass vials; each vial contains one dose. This formulation is not very stable unless all the ingredients have been pasteurized. Heating would however destroy much of the assumed beneficial activity of royal jelly. Ascorbic acid is frequently added for a more extended but still limited shei{life.

2) Ingredients for one dose:

Liquid and dry phases are maintained separately until use. The cod liver oil is contained in a special capsule from which it is released at the moment of use.

3) Ingredients for one dose:

A typical package contains 10-12 heat-sealed glass vials (see Figure 6.10). The top of a vial is easily broken off and small straws are provided to drink the liquid directly from the vial. Other types of sterile seals can be employed to make use of cheaper and more common bottling equipment. Preservation is a particularly difficult problem, as the liquid should not be sterilized by heat. Chemical preservatives are needed. The alcohol in the ginseng extract is often sufficient.

4) Ingredients (in parts by weight):

This product is fermented like mead, but the fermentation is stopped at a low alcohol content. Royal jelly is added after the fermentation. It is marketed as a special type of mead and bottled in dark, multi-dose bottles of 250 ml capacity.

6.11.6 Dried juice concentrate

Ingredients for one dose:

fructose
dried fruit juice powder
0.17 g freeze-dried royal jelly (equivalent to 0.5 g of fresh jelly)

A dried fruit juice powder, fructose (to taste) and the dry royal jelly are mixed. The dry powder is packed in plastic and aluminum lined paper envelopes in individual doses of approximately 4 g for one glass of reconstituted fruit juice. The production of good quality dried fruit juices requires expensive equipment. Pre-manufactured powders made from many different fruits may be purchased and enriched thus requiring only packaging equipment.

6.11.7 Tablets

Ingredients (in parts by weight) modified after Karaali et al., (1988):

A single tablet might contain 565 to 580 mg of ingredients, i.e. 100 mg of royal jelly.

Mannitol and lactose can be replaced by other powdered sugars. Glycine and the binding agents can be substituted with Agar Agar, pectin, gelatin, various gums, or beeswax. The sodium citrate can be replaced by citric acid. Flavours and dyes can be permitted natural plant extracts. Liquids (including water) should be added sparsely to obtain a thick gel, or an almost dry mass if the tablets are to be pressed. As with encapsulated formulations, freeze-dried royal jelly can be added to many herbal formulas.

6.11.8 Capsules

All the ingredients must be dry and in the form of a fine powder. They must be thoroughly mixed - the last ingredient to be added should be the royal jelly. Mixing and the final filling of the capsules should ideally take place in a room with very low humidity. For small quantities, a plastic bag provides a controlled atmosphere and can be shaken sufficiently. There are small electric ball mixers available which are well suited for medium to commercial quantities.

Final encapsulation into hard gelatin capsules can be done manually or with machines of varying capacities (see also 3.11.8). Dry powders are easiest to fill, but moist pastes such as those prepared with honey, can also be filled into capsules.

Formulations for soft gel capsules require oil based extracts, mixtures and expensive technology and are outside the scope of this bulletin.

Some possible powder mixes are (weights and proportions are only guidelines since no exact dosages are required):

1) Ingredients (in parts by weight):

2) Ingredients (in parts by weight):

All need to be pulverized (dry powders), mixed and encapsulated, 300-350 mg per capsule.

3) Ingredients (in parts by weight - all dried):

Again, all need to be mixed well before encapsulation. Exact proportions are not important for product consistency, but ingredient choice and quantities should be based on herbal characteristics. Other herbal formulations may be enriched with royal jelly and/or pollen, propolis etc. However, preparations with herbal extracts or herbal powders should be handled with caution and mixtures should only be designed by people with sufficient experience in herbal medicines.

6.11.9 Cosmetics

Royal jelly can be easily added to any creams or lotions, usually at a concentration of 0.1 to 1 % fresh or 0.03 to 0.3% freeze-dried royal jelly. The formulations generally do not have to be changed and thus any agreeable recipe can be adapted. Since royal jelly is already an emulsion, it can also be added to any existing cream providing the cream is not solely oil-based. Mix the royal jelly with a small quantity of the cream first and then add this mixture to the rest. For detailed recipes see Chapter 9.

² This chapter was written in Italian by Dr. Lucia Piana, translated by Lorenza Manzi and edited by R. Krell

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