Animal-Derived Ingredients in Cosmetics: Regulatory Requirements

Animal-Derived Ingredients in Cosmetics: Regulatory Requirements

The use of animal-derived constituents was pioneered at the beginning of the 18th century and slowly gained pace, soon after the advancement in science and technology. Earlier the application of animal-derived constituents was constrained to a few products such as leather products, colorants, cosmetics, etc. However, the scope of animal-derived constituents has also been extended to homecare, healthcare product formulations and modern medicine. For example, common medicines contain lactose, gelatine and magnesium stearate derived from animals.

Until the recent past, the regulations governing the animal-derived constituents were in the infancy stage. Ground-breaking development with respect to the regulations can be attributed to two (2) major dimensions. One, owing to the health risk emanated from the animal-derived constituents, and the other from religious and secular concerns. Studies show that animal-derived materials not only harbour but also support the growth of pathogens. Contaminated drug ingredients can cause potential health risks that may affect various patient populations, including immune-compromised patients as well as healthy people of all ages.

Halal Compliance

The term “Halal” is used to designate food that is permissible according to Islamic law. Halal is principally concerned with meat products. Thus, products containing pork (e.g. pork gelatin) and other animal-derived constituents are considered not Halal. However, alcohol is also not permitted making it not Halal. Halal is mostly recognized for its application to food but it also applies to cosmetics, pharmaceuticals and even business practices. For cosmetics, some products such as lipsticks and alcohol-based perfumes are of particular concern for the Halal seeking consumers. Halal compliance is necessary while exporting to the Gulf Cooperation Council (GCC), Malaysia, Indonesia and the Middle East, and it also has significance all over the world. One of the major challenges faced by cosmetic manufacturers is the practice of different Halal standards for different countries – some of the ingredients that may be Halal in some countries are either "not permitted" or "questionable" in others. GCC countries, which include the UAE, Saudi Arabia, Oman, Qatar, Bahrain, Kuwait and Yemen, have harmonized their Halal standards. The significance of obtaining Halal Certification has intensified more than ever with the increasing demand for Halal products across the globe.

Kosher Certification

‘Kosher’ is used to describe food that complies with strict dietary standards of the traditional Jewish law. In 2017, the global market for kosher food was estimated to be $24 billion. It is projected to grow at an 11.6% CAGR from 2017 to 2025, reaching nearly $60 billion by 2025. Kosher Certification Agency is the organization that grants a hechsher to beverages, ingredients, packaged foods and certain materials, as well as food-service providers and facilities, in which kosher food is prepared or served. Kosher also applies to non-food products such as cleaning products, food containers, water softeners, packaging and cosmetics. In order to obtain Kosher certification, each ingredient, food additive and processing aid used in its production, must also be Kosher certified/approved. There are annual Kosher certificates that are valid for a year from the date issued. Kosher-certified products are of particular importance to the Jewish population and many companies consider Kosher certification while exporting to countries like Israel, USA and UK.

BSE/TSE Certificate

TSE/BSE free certification is one of the important Regulatory requirements for animal-derived ingredients. Transmissible Spongiform Encephalopathy (TSE) is a family of diseases occurring in men and animals and are characterised by the degeneration of brain tissue giving a sponge-like appearance that leads to fatality. These include diseases like Bovine Spongiform Encephalopathy (BSE) also known as mad cow disease, Scrapie in sheep and Creutzfeldt-Jakob disease (CJD) in humans. The nature of the infectious agent that causes these diseases are unknown. However as per the most accepted theory, Prion which is a modified form of a normal cell protein considered as an agent for this disease.

TSE/BSE certification is the requirement for the ingredients which are derived from animals and could potentially be contaminated with TSE. TSE/BSE compliance certificate ensures that the animal-derived ingredients are free from the TSE/BSE and carry low risk. The EU regulation (EC) No 999/2001 covers the specification and requirements related to the TSE.

Majorly used animal-derived ingredients in cosmetics include Alanine, Lactic Acid, Honey, Beeswax, Cod Liver Oil, Cystine, Gelatin, Glycerin, Hyaluronic Acid, Keratin, Linoleic Acid, Musk, Polysorbates, Silk, Retinol, etc. However, in recent times, efforts are being taken to replace them with suitable alternatives.