The world of cosmetics is growing rapidly. The release of a wide variety of cosmetic products into the market has happened and is increasing day by day. While all these products are being released, it is important to not compromise consumer safety. To achieve this, cosmetic risk assessments are set in place and compliance with them is essential. Continue reading to learn about the regulatory standards, how it is conducted and more.
Importance Of Cosmetics Safety Assessments
The cosmetics that are marketed must be safe. This is one of the primary goals kept in mind while developing a product. Cosmetic risk assessments are done to make sure that this is achieved by every product which is intended to enter into the public. Adverse effects to the ingredients used in the formulation can occur to anyone. To avoid this or at least to reduce the incidence risk assessment are important. Toxicological profile, vulnerable population, potential hazards and many other information can be found. Most importantly, it assures cosmetic regulatory compliance.
Global Regulatory Standards For Cosmetic Safety Assessment
EU Cosmetics Standards:
Article 10 of regulation (EC) No. 1223/2009 speaks about the safety assessment of cosmetic products. This article states that prior to marketing a cosmetic product, the person responsible should make sure that the cosmetic product has underwent a safety assessment and also prepare a cosmetic product safety report in accordance with Annex I.
FDA Cosmetics Standards:
Except for colour additives, the cosmetic products and ingredients do not require approval before they are placed into the market. Instead, there are certain laws and regulations that apply to cosmetics. In the US, the main laws pertaining to the marketing of cosmetics are the FD&C Act (Federal Food, Drug and Cosmetic Act) and the FPLA (Fair Packaging and Labeling Act). Cosmetic products are regulated by the FDA under the authority of these 2 laws.
The FDA or the law does not require specific tests so as to demonstrate the safety of individual products or ingredients. Sharing of safety information by cosmetic companies to FDA is also not required by the law. However, it is the legal responsibility of the individual or the companies that manufacture or market the cosmetics to make sure the safety of their product. FDA can take enforcement action against products on the market which do not comply with the law. This also applies to any firms or individuals who are involved in the violation of the law.
Generally, except for the color additives and ingredients which are prohibited/ restricted by regulation, the manufacturer can use any ingredient in the cosmetic formulation, given that:
The ingredients and the final cosmetic product are safe under labeled or customary conditions of use.
The product is labeled appropriately and
The use of the ingredient should not cause any adulteration or misbranding of the cosmetic product under the laws that FDA enforces.
Health Canada Cosmetics Standards
All the cosmetics sold in Canada should be in compliance with the requirements of the Food and Drugs Act and the Cosmetic Regulation. Requirements coming under other legislation such as the Consumer Packaging and Labeling Act, Canadian Environmental Protection Act, 1999 and the Cannabis act should also be met, if applicable.
The manufacturing/ preparation, preservation, packaging and storing of the cosmetics must be under sanitary conditions. This is a requirement for the Cosmetic Regulations and the Food and Drugs Act for the cosmetics that are sold in Canada. Health Canada must be notified by the manufacturer and importer that they are selling the product. A list of ingredients in the product should also be given.
Components Of A Cosmetic Safety Assessment
The cosmetic product safety report has two parts. Part A and Part B.
Part A is about cosmetic product safety information and the latter is about cosmetic product safety assessment.
Part A must include information on the following:
1. The quantitative composition & qualitative composition of the cosmetic product
The cosmetic product’s qualitative and quantitative composition along with the chemical identity of the substances and the function they are intended for. Description of the name, code number of the composition and supplier identity must be provided in case of perfume and aromatic compositions.
2. Physical/chemical characteristics, stability of the cosmetic product
The physical as well as the chemical characteristics of the substances, mixtures and the cosmetic product. The stability of the product under storage conditions that are foreseeable.
3. Microbiological quality of the product
Microbiological specification about the substance, mixture as well as the cosmetic product. Special attention must be given to the cosmetics that are used around the eyes, on mucus membranes in general, on damaged skin areas, children younger than 3 years of age, in elderly, people with compromised immune systems. Preservation challenge test results must be provided.
4. Impurities, Traces, Information about the packaging material
Evidence must be provided for the technical unavoidability if traces of any prohibited substances are found. Information on the purity of the substances or mixtures. Characteristics of packaging material that are relevant, particularly with the stability and purity of the product.
5. Normal and reasonably foreseeable use
Information on normal as well as any foreseeable usage of the product. The reasoning should be justified in particular with the warnings or other explanations stated in the labeling of the product.
6. Exposure to the cosmetic product
The data on the cosmetic product exposure in relation to the site and surface area of application, product amount to be applied, duration and frequency, normal or any foreseeable route of exposure and targeted populations. Toxicological effects and the possibility of secondary route exposure must also be considered.
7. Exposure to the substances
The data regarding the substances used within the cosmetic product for relevant toxicological endpoints.
8. Toxicological profile of the substances
Additional to the requirements in Article 18, the toxicological profile of all substances in the cosmetic product for all relevant toxicological endpoints. Special attention should be made for the evaluation of local toxicity, skin sensitization, and for photo induced toxicity in case of UV absorption.
All routes of absorption that can cause toxicity must be considered. Systemic effects and margin of safety (MoS) should be calculated based on NOAEL (no observed adverse effects level). Non-appearance of these must be justified.
Consideration should be given to any possible effects on the toxicological profile due to the particle sizes (including nanomaterials), any impurities of the substances and raw material used, and substances interaction.
9. Undesirable effects and serious undesirable effects
All data regarding the cosmetic product’s undesirable and serious undesirable effects. It includes statistical data as well.
10. Information on the cosmetic product
Any other information about the cosmetic product that is relevant.
Part B must have the following information:
Assessment conclusion
Statement, in accordance with Article 3, on the cosmetic product’s safety.
Labeling and warnings statement, in agreement with Article 19 (1) (d), on the need for labeling warnings and user instructions.
Reasoning
Explanation regarding the scientific reasoning that led to the assessment conclusion in section 1 and statement in section 2. The explanation provided must be dependent on the description in Part A. Assessment and discussion of the margin of safety is done where relevant.
Assessor's credentials and approval of part B
Name and address, proof of qualification, date and signature of the safety assessor.
Among other things, there shall be a specific assessment for the cosmetics that are to be used in children less than 3 years and for cosmetics considered for their use in external intimate hygiene. Assessment of interaction of the substances in the cosmetic product, justification of consideration and non-consideration of various toxicological profiles, effect of stability on the safety of the product are also included.
Steps in Conducting a Cosmetic Risk Assessment
Risk assessment of cosmetics and their ingredients is a valuable method in recognizing any potential adverse effects that can develop from its use. The risk assessment process comprises 4 steps. They are:
Hazard Identification: It involves analyzing the toxicological profile of the cosmetic products and its ingredients.
Dose-response assessment: Depending on the dose and incidence relationship and the adverse effect occurred, the characterization of risk and its management is determined.
Exposure assessment: The level of exposure to cosmetic products and its ingredients is what is determined here.
Risk characterization: For the risk characterization of cosmetic ingredients, an approach used by SCCS (Scientific Committee for Consumer Safety) is by calculating the margin of safety. Generally, the MoS (margin of safety) is calculated depending on studies of oral toxicity unless strong data on dermal toxicity are available. For MoS, a toxicological point of departure (PoD), obtained from oral studies in test animals is used in the following equation:
MoS = PoDsys/SED
PoDsys (systemic PoD in mg/kg bw/day): is the potency descriptor, preferably a BMD (Benchmark dose) or alternatively a NOAEL (no observed adverse effect level) or LOAEL (lowest observed adverse effect level) from a repeated-dose toxicity study. SED, the systemic exposure dose (mg/kg bw/day) is the dose descriptor for the systemic exposure to the substance calculated as the amount of the substance absorbed systemically from cosmetic products. Margin of Safety that is equal to 100 or greater is an indicator for safety of the substance.
Role Of A Cosmetic Safety Assessor
The role of a safety assessor includes to determine whether or not: -
The ingredients contained in the formula meet all the legal requirements.
For a given ingredient, any particular endpoints must be considered
The data that is available is relevant and sufficient.
Any need for complementary data regarding the finished product or the ingredients.
Any changes in the toxicological relevance or modification in the product penetration can occur.
A safety assessor must have access to the analytical as well as the toxicological information regarding the product from a safety point of view. Apart from this they must not be involved in the commercial aspect of the product. The safety assessor must also adhere to the professional ethics in the field.
How To Be In Line With Cosmetic Regulatory Compliance?
There are regulations for each product that is being marketed. Likewise, there are cosmetic safety regulations too. Even though there can be changes in the regulations or requirements, some things will be on demand at all times. The safety, quality and the effectiveness of the product for the use it is intended for. Following proper GMP practices and satisfying safety and quality tests will make sure that you are automatically in compliance with the regulations.
There can be omissions/additions of certain tests, standards or documents needed for the risk assessment and marketing from time to time. Staying up to date with the regulatory framework, getting in touch with regulatory professionals and moreover following the instructions mentioned in the respective guidelines can help.
These can also be challenging at times and may fail to comply with the regulations. Artixio Consulting can help you streamline your journey towards commercialization of your cosmetic product. Our team of experts provides support right from the development of the cosmetic product. We also make sure that the product is in compliance with all the regulatory requirements. Reach out to us at info@artixio.com
FAQs
Q. What is the purpose of cosmetic risk assessment compliance?
A: The purpose of cosmetic risk assessment compliance is to demonstrate that the cosmetic product is safe for consumer use. Moreover, it makes sure that the cosmetic product satisfies all the safety and legal requirements. It is also relevant in detection and prevention of any undesired health effects.
Q. What does a Cosmetic Product Safety Report (CPSR) include?
A: The Cosmetic Product Safety Report includes data on the composition of the product, toxicological profile, physicochemical characteristics, stability, microbiological quality, exposure to the product, impurities, traces, packaging material, undesirable effects and any other related information on the cosmetic product.
Q. Who can perform a cosmetic safety assessment?
A: Safety assessor is the one who assesses the safety of the cosmetic product. He/she must be a qualified person. They must own a diploma in the field of pharmacy, toxicology, dermatology, medicine or in a similar field.
Q. What challenges do companies face in cosmetic risk assessment compliance?
A: Some major challenges include keeping up with the evolving regulations, proper documentation and maintenance of all the data, multi-region compliance and financial challenges.
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