**6. Regulatory affairs**

nation of silicon dioxide with arabic or modified starch and silicon dioxide by spray‐drier. They have successfully obtained a standardized propolis extract with high amount of propolis, flavonoid content, expected amounts of artepillin C, and with maintained antibacterial activity, and obtained microparticles with both excipients used. Recently, results of the same group obtained dry extracts of propolis with 70–80% of dry matter; however, the microparticles were not obtained (data not published yet), and then, the odor, color, and taste are not similarly reduced as it is possible to observe when microparticles are obtained (**Figure 10**). Although microparticles were not obtained with 70–80% of propolis dry matter, this extract is the most concentrated one found in the market until now and can be used in several products with very

**Figure 10.** Propolis standardized water extracts of green propolis; C: propolis standardized extract (EPP‐AF®).

In general, the propolis powder extracts obtained by spray‐drying technique investigated in the literature demonstrated the formation of particles at the micrometer scale, from 1 to 10–20 μm. On the other hand, as nanotechnology can offer new opportunities for propolis applica‐ tion, in another line of research, nanosized particles have been developed. Patil et al. [130] have obtained and characterized silver nanoparticles containing propolis [130]. Propolis nanopar‐ ticles have also been obtained employing lipid carriers. Our research group has focused on developing solid lipid nanoparticles (SLN) and nanostructured lipid carriers (NLC) encapsu‐ lating propolis. **Figure 11** shows atomic force microscopy (AFM) images of propolis‐loaded NLC. Additional studies were also conducted covering NLC surface with chitosan. The chitosan‐covered particles presented positive residual surface charge [≈ +40 mV], while the uncoated ones presented negative charges [≈ −30 mV]. Particles were anisometric in shape and approximately 150–200 nm in size. The images demonstrate the particle surface and confirm the nanometric size of the particle. Additionally, no roughness was observed on the particle

good results, for example soft or hard capsules or tablets.

78 Superfood and Functional Food - An Overview of Their Processing and Utilization

surfaces.

Functional food and natural health products have become an important part of people's daily diet, contributing to the general health of the population and boosting the global food industry. Therefore, its importance is reflected in the interest in regulation of health claims and standards from industry stakeholders and policymakers.

In this chapter, we examine propolis product regulations and policies in many important producing and consuming countries around the world. The goal of this study is to incentive legislators to update the regulation on propolis products in order to improve information available to consumers so they can make better choices and also be provided with healthier and more innovative options.

The regulatory climate worldwide appears to be tending toward propolis classification into the health food products category, although this category also has different names, registration requirements, and allowed claims throughout the world.

Nevertheless, there are still some countries that categorize propolis as a conventional food together with the other bee products, such as honey, royal jelly, and bee pollen. That is the case of Brazil, where the product is regulated by the Ministry of Agriculture with very stringent regulation that limits the product's presentations, information to consumer and does not allow health claims. In 2005, the Brazilian "National Health Surveillance Agency" (ANVISA) published a technical note allowing the registration of propolis as a topical medicine with the claims of anti-inflammatory, antiseptic, and wound healing [132]. The publication of another regulation [133] reinforced the same rules but, due to the very strict rules for medicines, although Brazil is one of the biggest propolis markets, there are no propolis medicines registered to this date.

In the United States, propolis is encompassed together with a wide range of substances by the definition of a dietary supplement in the Dietary Supplement Health Education Act of 1994 (DSHEA) [134]. The use of function claims is also regulated by the above-mentioned regulation that established some special regulatory requirements and procedures for claims of general well-being. These claims are not preapproved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim.

In the European Union (EU), propolis belongs to the food supplement group, regulated by the Directive 2002/46/EC [135], which defines the category as concentrated sources of nutrients or other substances with a nutritional or physiological effect. Since 2006, EU has been engaged in assessing generic health claims to surpass local regulation of member states and after this harmonization product's labels can only bear health claims authorized by the European Food Safety Authority (EFSA) [136], which evaluates scientific data on claims provided by the applicant. Up to this date, there is still no authorized health claim for propolis.

In Australia, all food supplements fall within the category of "complementary medicines" under the *Therapeutic Goods Act 1989* and the supporting Therapeutic Goods Regulations 1990 [137], in which the substances are evaluated according to their level of risk. It includes vitamin, mineral, herbal, aromatherapy, and homeopathic products. A positive list of low-risk substances that may be used has been established and propolis is one of them. It can be used as an active, excipient, or component in all listed medicine formulations. Propolis products can make indications for health maintenance and health enhancement or certain indications for nonserious, self-limiting conditions. It is the manufacturer responsibility to hold evidence to support any indications as well as any other claims made for the medicine (according to Requirements of section 26A of the Act).

In this chapter, we examine propolis product regulations and policies in many important producing and consuming countries around the world. The goal of this study is to incentive legislators to update the regulation on propolis products in order to improve information available to consumers so they can make better choices and also be provided with healthier

The regulatory climate worldwide appears to be tending toward propolis classification into the health food products category, although this category also has different names, registration

Nevertheless, there are still some countries that categorize propolis as a conventional food together with the other bee products, such as honey, royal jelly, and bee pollen. That is the case of Brazil, where the product is regulated by the Ministry of Agriculture with very stringent regulation that limits the product's presentations, information to consumer and does not allow health claims. In 2005, the Brazilian "National Health Surveillance Agency" (ANVISA) published a technical note allowing the registration of propolis as a topical medicine with the claims of anti-inflammatory, antiseptic, and wound healing [132]. The publication of another regulation [133] reinforced the same rules but, due to the very strict rules for medicines, although Brazil is one of the biggest propolis markets, there are no propolis medicines

In the United States, propolis is encompassed together with a wide range of substances by the definition of a dietary supplement in the Dietary Supplement Health Education Act of 1994 (DSHEA) [134]. The use of function claims is also regulated by the above-mentioned regulation that established some special regulatory requirements and procedures for claims of general well-being. These claims are not preapproved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement

In the European Union (EU), propolis belongs to the food supplement group, regulated by the Directive 2002/46/EC [135], which defines the category as concentrated sources of nutrients or other substances with a nutritional or physiological effect. Since 2006, EU has been engaged in assessing generic health claims to surpass local regulation of member states and after this harmonization product's labels can only bear health claims authorized by the European Food Safety Authority (EFSA) [136], which evaluates scientific data on claims provided by the

In Australia, all food supplements fall within the category of "complementary medicines" under the *Therapeutic Goods Act 1989* and the supporting Therapeutic Goods Regulations 1990 [137], in which the substances are evaluated according to their level of risk. It includes vitamin, mineral, herbal, aromatherapy, and homeopathic products. A positive list of low-risk substances that may be used has been established and propolis is one of them. It can be used as an active, excipient, or component in all listed medicine formulations. Propolis products can make indications for health maintenance and health enhancement or certain indications for nonserious, self-limiting conditions. It is the manufacturer responsibility to hold evidence to support

applicant. Up to this date, there is still no authorized health claim for propolis.

and more innovative options.

registered to this date.

with the claim.

requirements, and allowed claims throughout the world.

80 Superfood and Functional Food - An Overview of Their Processing and Utilization

Food supplements in Canada are regarded as "Natural Health Products" under the Natural Health Products Regulations (SOR/2003‐196) [138–141] and may contain a wide range of substances, such as vitamins and minerals, herbal remedies, homeopathic medicines, tradi‐ tional medicines, and probiotics. All products must be safe to use as over‐the‐counter products and not need a prescription to be sold. Propolis is positive listed to be used orally in multiple pharmaceutical dosage forms as a source of antioxidants for the maintenance of good health and to help relieve sore throat and/or other mouth and throat infections. It can also be used topically to assist in minor wound healing.

Japan is one of the first countries to move toward regulating functional foods. There are lists containing a broad range of substances that are not restricted to medicinal use and can therefore be used in food supplements. Propolis in this scenario can be used as an authorized excipient under the Food Sanitation Act 2010, as regular health food without any claims or as an active of a "Food for Specified Health Uses" (FOSHU) [142] with health claims.

The Republic of Korea defines functional food significantly differently from other countries, restricting functional food to nutraceuticals. They are regulated under the Health Functional Food Act of 2004 [143] and there is a positive list in the Health Functional Food Code with 37 categories. Propolis preparations in all forms are allowed and may include two health claims: antioxidant activity and antimicrobial activity in oral cavity.

The People's Republic of China is another example of an Asian country that uses a product‐ specific system of registration. The State Food and Drug Administration in China (SFDA) [144] regulates these food supplements as "health foods" and maintains positive and negative lists of substances that may be used in health foods. Propolis is in the positive list. There are 27 categories of health function claims approved by the SFDA, but the regulatory process for achieving approval of these health claims is very strict and expensive, requiring the applicant to conduct nonclinical or even clinical studies through an approved agency in addition to the regular scientific literature review.

With this brief regulatory framework on propolis products, we have presented different policies and regulations around the world and we hope that policymakers can improve the regulatory scenario in the near future in order to accelerate and foster innovation in the sector.
