A Review on the Cosmetics Rule 2020 and ISO 22716 Volume 53- Issue 5

Swathi J and Nagasamy Venkatesh D*

• Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru), India

Received: November 15, 2023; Published: November 22, 2023

*Corresponding author: Nagasamy Venkatesh D, Department of Pharmaceutics, JSS College of Pharmacy, Ooty-643 001, Tamil Nadu, India

DOI: 10.26717/BJSTR.2023.53.008469

Abstract PDF

Cosmetics shall be defined as any article intended to be rubbed, poured, sprinkled, or sprayed into, or otherwise applied to, the human body or any part thereof for the purpose of cleaning, embellishing, promoting attractiveness or altering appearance, and shall include any article intended for use as a component of cosmetics. Good Manufacturing Practices for Cosmetics ISO 22716:2007 is the international standard for the Good Manufacturing Practices (GMP) for cosmetics. ISO 22716 provides guidance to documenting and regulating the production, control, storage, and shipment of cosmetic products. In this article, we discussed the new Cosmetic Rules 2020 which set out separate guidelines for the import and registration, manufacture, labeling and packaging of cosmetics in terms of sale or distribution, sampling procedures, approval of laboratories for testing and alternative tests for cosmetics.

Keywords: Cosmetics; GMP; ISO 22716; Cosmetic Rules

Cosmetics shall be defined as any article intended to be rubbed, poured, sprinkled, or sprayed into, or otherwise applied to, the human body or any part thereof for the purpose of cleaning, embellishing, promoting attractiveness or altering appearance, and shall include any article intended for use as a component of cosmetics. To ensure the quality, safety, and efficacy of cosmetics. Strict regulations are being laid down and followed by regulatory authorities in all countries and regulations vary from country to country [1]. Cosmetics have been in use for ages and are a booming business now; they are an essential part of life and have increased demand over the last 3-4 decades. The first evidence of cosmetics was found in 4000 B.C. It was in ancient Egypt and Greece. The word cosmetics were derived from the Greek word "Cosmetics" which means "qualified in ordering and arranging"[1]. Cosmetics are used to enhance attractiveness, to alter appearance, to protect against UV rays to treat skin problems.

The cosmetics are classified as:

1. Skin Cosmetics: Cleansing preparation, skin moisturizers, skin tonic, shaving cream, face mask, vanishing cream, lotions, body butters, powders etc.

2. Hair Cosmetics: Hair dyes, hair oils, hair creams, hair gels, hair removing creams, shampoos etc.

3. Eye Cosmetics: Eye liners, eye gloves, kajal, Surma, contact lens, eyebrow pencil etc.

4. Nail Cosmetics: Cuticle creams, oils and removers, nail polish, nail stain removers etc.

5. Dental and Oral cavity Cosmetics: Toothpaste, tooth powders, mouth washes, teeth whitening, whitening etc.

6. Antiperspirant and Deodorants: Powder, liquid, creams and sticks etc.

7. Miscellaneous Cosmetics: Anti stress marks, black head removers, toilet soaps etc. [2] (Figure 1).

Figure 1

In the exercise of the powers conferred by Sections 12 and 33 of the Drugs and Cosmetic Act 1940, the Central Government, after consulting the Technical Advisory Board on Drugs, made the rules for cosmetics 'Cosmetic Rules 2020'.The CDSCO referred to in Section 3 (aaa) defines cosmetics as 'any article intended to be rubbed, poured, sprinkled or sprayed onto, or otherwise applied to, the human body or any part thereof for cleaning, beautifying, promoting attractiveness or altering appearance, and includes any article intended for use as a component of cosmetics [3,4]. Schedule S of the Drugs and Cosmetics Act 1940 and the Ninth Schedule of the Cosmetics Rules 2020 laid down the final form standards that comply with the Indian Standard Specification laid down by the Bureau of Indian Standards (BIS) [5].

Cosmetic Rules, 2020

In order to codify and update the rules on cosmetics on a stand-alone basis, the central government published the Official Cosmetics Rules 2020 Gazette, which sets out separate guidelines for the import and registration, manufacture, labeling and packaging of cosmetics in terms of sale or distribution, sampling procedures, approval of laboratories for testing [6]. The Cosmetic Rules, 2020 consists of, 9 Chapters, 13 Schedules and Appendix (24 Forms) which is given in (Tables 1-3).

Table 1: Cosmetics Rules, 20 (chapters).

Table 2: Cosmetics Rules,2020 (Schedules).

Table 3: Cosmetics Rules. 2020 (Forms).

The Seventh Schedule of the Cosmetics Rule 2020 sets out the Good Manufacturing Practice (GMP) and the requirements of premises, plants and equipment for the manufacture of cosmetics, which are divided into two parts, general requirements and plant and equipment requirements [7]. The General requirements include,

• Location and surroundings

• Buildings

• Personnel

• Water Supply

• Disposal of waste

• Health, clothing, and sanitary requirements of the staff

• Medical services

• Maintenance

• Testing and release of raw materials & finished cosmetic products.

• Washing facilities

Requirements of plant and equipment for powders, skin powders for infants, creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving creams and hair-oils, nail polishes and lacquers, lipsticks and lip gloss, depilatories, eyebrows, eyelashes, eyeliners, kajal and Surma, aerosols, alcoholic fragrance solutions, hair dyes, tooth powders, tooth paste and toilet soaps are explained and these are categories of cosmetics, for which the license will be granted for manufacture [8].The equipment and the area required for the manufacturing are given below in (Table 4). The manufacturing record should contain the following,

Table 4: Requirements of plants and equipment’s.

Labelling and Packaging of Cosmetics

No person may manufacture, sell, or distribute cosmetics unless they are labelled and packaged in accordance with the Cosmetic Rules of 2020.

Manner of labelling

a. Name of the Cosmetics

b. Name of the manufacturer with complete address

c. Nam e of the country where it was actually manufactured.

d. Expiry (date and month)

e. Batch No. or Lot No.

f. Manufacturing License Nurnb er

g. Net Content and. weight

h. Name and quantities of the ingredients

i. Directions for safe use

j. Warning, cautions, or special directions required.

k. Import Registration Certificate Numberer (Reg. Cert. No)

• If a cosmetic package has only one label, the information present in both the inner and outer label should be present in the label.

• The alteration, obliteration or deface any inscription or mark made or recorded by the manufacturer or the container, label and wrapper shall not be done unless permission is obtained from the Central Licensing Authority.

• False and misleading claims are prohibited.

• If any ingredient is a product produces skin irritation or harm “caution” shall me mentioned

• The product should contain instructions in both English and local languages.

• Toothpastes containing fluorides should not be above 1000 ppm and the expiry date should be mentioned in both the tube and carton [9] (Table 5).

Table 5: Particulars of manufacturing record.

Some of the Provisions Cosmetics as Per Cosmetics Rule, 2020

• Toothpastes containing fluorides shall not be more than 1000ppm, the fluoride content and the expiry date should be mentioned on tube and carton.

• Arsenic Trioxide- 2 parts per million of Arsenic

• 20 parts per million of lead

• 100 parts per million other that lead considered as the respective metals total.

• Soaps – Hexachlorophenes, should not exceed 1% w/w and should be mentioned “not to be used on babies.”

• Cosmetics containing mercury should not exceed 0.007 per cent (for eyes) and for finished products not exceeding 1ppm.

• Lead and Arsenic for colouring cosmetics is prohibited.

• Animal study for cosmetics is prohibited.

Schedule ten of the Cosmetics Rule 2020 sets out colorants that may be used in cosmetic products as specified in the Cosmetics Rules 2020 are Phthalocyanine Blue, Citrus Red No.2, Aqueous Green Paste, Pigment Yellow 3, Irgalite Carmine F-P Powder or Pigments Red 5 and Monolite Red 4R HV Paste or Pigment Red 7 [10]. The Ninth Schedule sets out Indian standards for finished cosmetic products as amended by the Bureau of Indian Standards (Table 6).

Table 6: International Cosmetics Regulations.

International Cosmetics Regulation

The Cosmetics have different standards and regulation globally and the comparison of the cosmetic regulation of India with other countries is given below [11].

ISO 22716 - Cosmetics - Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices

ISO 22716 has established guidelines for the production, control, storage, and delivery of cosmetic products, covering both the quality and safety aspects of cosmetics. Good Manufacturing Practices follow the principles of sound scientific assessment and risk assessment for the production of products with defined characteristics.

The key elements of ISO 22716 are,

• Quality management system and organization

• Premises and equipment

• Product realization and materials management

• Deviations, complaints and recalls.

• Continuous improvement

Quality Management System and Organization: The main focus of the GMP is on the establishment and maintenance of qualified personnel capable of producing a safe and effective product. The personnel in the cosmetics manufacturing company should have a strong knowledge and the tasks and responsibilities should be clearly described. In addition, the establishment of effective internal and external communication channels must be a top priority. In addition, the establishment of effective internal and external communication channels must be a top priority for management to ensure the participation and commitment of staff at all levels of the organization [12].

Premises and equipment: Proper design of manufacturing, storage, quality control and other areas is a key element and is well described in the standard. Areas should be adapted to their purpose in order to allow proper access and flow of materials. Clear separation of manufacturing and storage activities and proper cleaning and sanitization are important in order to avoid mix-ups and (cross-) contamination. Scheduled maintenance of premises and equipment and frequent calibration of monitoring equipment must be organized in the facility in order to perform tasks in accordance with defined and pre-defined parameters of manufacturing, packaging, and storage. Within all of these aspects, the quality unit of the organization must be strongly involved in the approval and assessment of any changes that occur and make it possible [13].

Product Realization and Materials Management: The organization working under ISO 22716 must set quality criteria at different stages of production, such as the specifications for raw materials, components and packaging materials purchased. In addition, criteria should be laid down for the testing and release parameters of starting materials, intermediates (also referred to as cosmetic ingredients) and finished products. It is important that these characteristics are strictly followed by a clear indication of the quality status of these materials throughout the entire supply chain of operations. In this regard, it is important to note that contractors, such as third-party transporters and packaging units, must be included in the organization's quality efforts. Changes in the quality status of starting materials and (intermediate) products are solely the responsibility of the Quality Unit and, for this reason; this unit needs to be fully integrated into the operational activities of the organization [14].

Deviations, Complaints and Recalls: Each organization needs to have a system in place to deal with variations that occur anywhere in the supply chain of operations. These variations can have multiple origins and occur both internally and externally, e.g., during transport to a customer organization. These customer organizations need to be able to make complaints, if necessary, and the organization working under the ISO 22716 quality regime should investigate these complaints until a satisfactory solution has been found and communicated to the customer. In the event of serious quality deviations, which pose a serious threat to consumer health and safety, the organization needs to be able to coordinate an effective recall of the product or products [15,16].

Continuous Improvement: GMP is a quality system that makes use of state-of-the-art organizational aspects relevant to the cosmetics industry. For this reason, organizations need to be aware of current practices in their field and to aim for continuous improvement of quality in their operations and throughout their supply chain. The auditing process is the ultimate tool to do this. Internal audit is an inherent part of Cosmetics GMP in which non-compliance is documented, assessed, resolved, and prevented from recurring in the future. The optimal auditing system is the basis for efficient Corrective Action/Preventive Action (CAPA) planning [17].

1. Integrates the typical requirements for product and process quality Good Manufacturing Practices requirements with additional quality guidance, for example as laid down in the requirements of ISO 9001.

2. Easy implementation sizes and levels of complexity are allowed in all organizations.

3. Forms an internationally accepted basis for quality and safety compliance in the supply chain of cosmetic products.

4. Throughout the supply chain the cosmetic products hazards are controlled and help in the promotion of improvement continuously (Table 7) [18].

Table 7: Difference between Cosmetics Rules, 2020 (Seventh Schedule) and ISO 22716.

Cosmetics plays a very important role and has been increasingly demanding for decades. Regulations are being put forward globally for the production of high-quality and safe cosmetics. The Regulations for Drugs and Cosmetic Regulations was found that the Single Regulations for Drugs and Cosmetic did not provide strict provisions on drugs and cosmetics regulation; in order to codify all the regulation on cosmetics, the Government of India has published the Official Gazette, the new Cosmetics Regulation, 2020. All information on cosmetics is clearly presented in these new rules.

1. Dhull K, Swagat Tripathy, Harish Dureja (2015) Cosmetics: Regulatory Scenario in USA, EU and India 3(2): 127-139.
2. (2018) List of RC Holders and RC issued in Offline mode From 2013 to 2017.
3. (2022) Cosmetics & U.S. Law.
4. (2023) ICCR (International Cooperation on Cosmetic Regulation).
5. Mark TD Cronin, Steven J Enoch, Judith C Madden, James F Rathman, Andrea Nicole Richarz, et al. (2022) A review of in silico toxicology approaches to support the safety assessment of cosmetics-related materials 21:100213.
6. Bhuvaneswari VS, Chandan RS (2018) Review of safety assessment of a cosmetic product. International Journal of Current Pharmaceutical Research 10(3): 1-6.
7. (2009) Cosmetic products definition in the EU.
8. (2015) Regulatory Requirements for Exporting Cosmetics to Japan.
9. EU UK Cosmetic Responsible Person.
10. (2020) Cosmetics Regulation in Australia.
11. (2014) FTC to L’Oréal: Scientific claims need proof that’s more than just skin deep.
12. (2020) Dagenham cosmetics company fined for incorrectly labelling ingredients on products.
13. (2020) Norway Bans Fair & Lovely Creams For Mercury Content, HUL Says 'Could Be Counterfeit’.
14. Uttarakhand Tunnel Collapse: What Is The 5-Point Action Plan Adopted To Rescue 41 Trapped Workers?.
15. Cancer-causing chemical found in J&J shampoo.
16. Cosmetics manufacturers come under FDA lens.
17. (2019) FDA Advises Consumers, Tattoo Artists, and Retailers to Avoid Using or Selling Certain Tattoo Inks Contaminated with Microorganisms.
18. (2023) Warning Letters Related to Cosmetics.