Questions and Answers
Cosmetic products that do not contain color additives, or other materials that require approval for use, do not require FDA approval prior to marketing.
In contrast, cosmetic products that belong to the over-the-counter (OTC) category require listing of the drug product(s) and drug substance(s)/active ingredient(s) that are added to the cosmetic products. Cosmetic manufacturers and packaging companies (outside the US) who want to export their products to the US are committed to registering their foreign establishments, factories and manufacturing facilities.
Since the 1980s, the field of medical cosmetics has developed. Medical cosmetics can cure damage such as skin aging, sagging and scars, and many other aesthetic problems. Medical cosmetics, also known as paramedical cosmetics, combine medical and pharmaceutical substances (such as hyaluronic acid and sunscreens) in quantities that exceed the concentrations permitted in conventional cosmetics.
The process for authorization to market, import and manufacture cosmetics in Israel is designed to protect public health and constitutes a regulatory barrier to marketing of non-quality products and/or unsafe use. You must first apply for a general cosmetic license from the provincial (regional) pharmacy according to the location of the cosmetics warehouse. Only after obtaining that license can “Licensing Procedure and Registration of Cosmetics” forms and documents be submitted, according to the type of cosmetic. A license is granted for a period of five years.
Over-the-counter (OTC) medicines may be purchased without a prescription. In recent years, the selection of drugs that come under the category of OTC is growing. Manufacturers of cosmetics belonging to the OTC category are required to register the drug product(s) or drug substance(s)/active ingredient(s) that are added to the cosmetic products.
Organic cosmetic products contain mainly plant ingredients, are not tested on animals, and are packaged in glass containers and recycled cardboard.
They do not contain any harmful ingredients such as preservatives or petroleum products, and do not contain animal-derived ingredients.
Natural cosmetics are based on ingredients which include vegetable oils, essential oils, clay, herbs, vitamins, minerals, and natural waxes and butters of various kinds. The raw materials on which natural cosmetics, such as ointments, masks and more, are based must be prepared and used in ways that can maximize their benefits.
Cosmetic validation is documented evidence which provides a high degree of assurance that equipment, systems, process, testing methods, manufacturing processes, cleaning methods and software for cosmetics will consistently produce a result that meets predefined specifications and quality metrics. The purpose of validation is to ensure that the cosmetic products meet all the quality, efficacy and safety requirements that have been set for the final product, during all stages of production, and in different batches of the same product, while adhering to a controlled and documented process.
The purpose of a cosmetic quality system is to ensure the quality of the product and to protect the health of the consumer. ISO 22716 is an international standard for cosmetics GMP and supplements the requirements of the European Cosmetics Directive and Regulation. This standard is a measure of an enterprise’s ability to produce and deliver high-quality, safe cosmetics for consumer use.
To the article Quality Assurance Systems and CAPA
It is the responsibility of the Ministry of Health to ascertain the intended purpose of a cosmetic product and if it fulfills that purpose as stated on the packaging. In addition, the Ministry of Health must ensure that the ingredients contained in cosmetics are worthy of use, cannot cause harm to the user, and are not known to be substances that are dangerous to the public. However, sometimes people develop irritations, sensitivities or allergies to substances found in cosmetics, such as lead, aluminum, parabens (preservatives) and more.
The purpose of proper manufacturing conditions, or good manufacturing practice (GMP), in the cosmetics industry is to ensure that cosmetics are manufactured in accordance with quality system requirements. GMP, among other things, deals with minimizing risks involved in the production process and covers all aspects of production, from starting and raw materials, vendor and supplier certification, production facilities, production processes, employee conduct and training, cleaning procedures, equipment and process validation and final product testing.
In Israel, the GMP cosmetic review procedure is carried out by the Ministry of Health.
In the US, GMP is codified in 21 CFR part 701, and in Europe as part of Directive 76/768/EEC.
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Lab-grown meat is made from stem cells, taken from farm animals such as live cows, which are transferred for propagation and then grown into muscle and tissue strips.
Clean meat is meat-free; that is, “meat” created from vegetable protein substitutes such as pea or bean protein.
On August 5, 2013, the first hamburger-sized, lab-grown food patty was eaten in a laboratory in London.
Scientists from the Netherlands used stem cells taken from a cow to subsequently grow them into muscle strips that were eaten as the first lab-grown hamburger.
The first lab-grown hamburger, created in 2013, then cost $325,000 per unit. In 2015, the unit cost plummeted to $11. As more companies enter this field, coupled with the use of advanced industrial technologies, the price will decrease and is expected to eventually be significantly less than that of a “regular” burger produced from animal meat.
Creating 150 grams of beef requires 660 liters of water, most of which is consumed by the cattle. To produce a vegetable-substitute “meatball” the same weight as a beef-based meatball, only 58 liters of water is required.
HACCP is the acronym for Hazard Analysis Critical Control Point.
HACCP is a systematic, preventative approach to help ensure food safety and prevent risks to food products and dietary supplements. The HACCP system includes documentation and control mechanisms designed to identify and determine potential hazards in the production of food products and industrial food/nutritional supplements. Although HACCP is very important, it covers only part of food GMP requirements, and is currently considered inadequate on its own.
HACCP is based on a program created by NASA, Pillsbury and the US Army Laboratories in the 1960s to deal with safety and control of risks involved in manufacturing food products and industrial supplements, particularly for safe food to be used in space expeditions.
Food products are consumed by humans and therefore non-quality or substandard food products can endanger human life.
With a quality system, the number of quality and safety defects, and risks from food products, will decrease accordingly.
The more the food industry embraces technology, machinery and software, and adheres to standards of proper manufacturing conditions, the more efficient, profitable and high quality it will become, will enable companies to be competitive vis-à-vis the traditional food industry, and will boost consumer confidence.
Good manufacturing practice (GMP) in the food and dietary/nutritional supplements industry is designed to ensure that food products and dietary/nutritional supplements are manufactured in accordance with quality system principles. Proper implementation of GMP will minimize risks involved in the production process and allow the manufacturer to identify, neutralize and prevent them prior to final product testing. GMP covers all aspects of production, supplier certification, raw material acceptance, production facilities and production operations, employee training, cleaning procedures and validation.
In the Israeli food industry, procedures are audited and enforced by the Ministry of Health monitoring unit.
In the US, GMP is enforced under 21 CFR part 101, and in Europe as part of Directive 2002/46/EC.
- Application: The applicant must complete a permit application form for marking food products with the appropriate GMP conditions symbol, provide the required documents and submit them to the unit for adequate production conditions in the National Food Service.
- Examination of the application: Upon receipt of the application, and assuming that the documents are valid, the application will be referred for the Health Bureau’s opinion. The decision to audit or inspect the factory is at the discretion of the district engineer.
- Document completion: If, after reviewing the documents, there are any missing documents, a document completion request will be sent to the factory. Once the documents have been submitted completed, the process will continue.
- Issue permit: For food establishments and nutritional supplements that meet the requirements, a permit will be issued to mark the food products with the GMP symbol.
Nutritional supplements are products that are consumed in addition to regular foods. They are designed to supplement dietary needs and provide the body with nutrients that may be essential for its function, and which are either nonexistent or low in food, for example, vitamins, minerals, fatty acids, and amino acids.
Food additives, in contrast, are ingredients added to industrial foods for purposes of production, processing, preparation, handling, packaging, transport or storage of food, including improving its appearance, smell, texture, flavor or color. Examples of food additives include food colors, stabilizers and preservatives.
Israeli manufacturers of food and/or dietary supplements that meet the threshold conditions below:
- Holders of valid certificates attesting to the ISO 9001 quality system standard issued by Control Institutes recognized by the Ministry of Health.
- Owners of a valid business license provided by the local authority.
- Holders of a valid manufacturer’s license issued by the provincial health bureau within which the plant is located.
- There is a list of food products manufactured at the factory.
- The plant employs a food engineer/technologist at the plant.
- There is a good and valid health report.
Performing a Scientific and Systematic Risk Survey includes listing manufacturing processes in which potential hazards exist while describing the corrective and preventive actions for these risks.
- Perform hazard analysis.
- Find and identify the critical control points (CCP).
- Set boundaries (establish critical limits) for the critical control points, and determine the range beyond which the product will be considered unsafe.
- Determine and create monitoring measures for the control points and define them in work procedures and production instructions based on the limits defined at the identified critical control points.
- Decide on corrective actions to be taken if deviations from the critical limits occur.
- Verify and record (document) all actions, taken at all stages, of the process and controls.
- Write, approve and provide guidance on procedures to verify that the various systems and processes are working as required and are effective.
The National Food Service is the body of the Ministry of Health that deals with the registration of food and nutritional supplements. It has the authority to carefully review the safety and quality of each product. Only after meeting the conditions and guidelines for applying for registration and importing nutritional supplements, while implementing the high standards of the Ministry of Health, will approval for marketing of the nutritional/food supplement in Israel be granted.
The National Food Service of the Ministry of Health monitors food and should ensure it has no biological or chemical contamination.
The Ministry of Agriculture veterinary services set standards and monitor all animal breeding conditions in the animal food industry.
A quality system in the food and dietary/nutritional supplements industry should ensure the quality of the food or dietary supplement to protect the health of the consumer. Quality and safety of food products and dietary supplements are important, and therefore it is the responsibility of quality managers to inform and involve the senior management of the company in any situation where a safe and high quality product which meets all release specifications cannot be reached.
To the article “Quality Assurance Systems and CAPA“
Validation is documented, proven evidence which provides a high level of assurance that the production process of food products and/or nutritional supplements will consistently produce products that meet predefined qualifications and quality features. The purpose of the validation process is to ensure that the food products and/or nutritional supplements meet all the quality, efficacy and safety requirements set for the final product, during all stages of production and in different batches of the same product, while adhering to a controlled and documented process.
Food tech is a combination of the words “food” and “technology”. Food tech companies combine the production of food products with the use of advanced technologies. Integrating advanced technology into the field of food production enables promotion, streamlining and supply of healthier food products, and reduction of the impact on the environment.
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