THE CURRENT REGISTRATION REGULATIONS OF COSMETIC PRODUCTS IN “BRICS” COUNTRIES
HTML Full TextTHE CURRENT REGISTRATION REGULATIONS OF COSMETIC PRODUCTS IN “BRICS” COUNTRIES
R. Sathyalakshmi, N. Jaipratap and C. Sowmya *
Department of Pharmaceutical Regulatory Affairs, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, India.
ABSTRACT: Cosmetic products are produced by the most inventive and technically driven methods to reach more consumers in the developing world. Cosmetic products are also regulated, similar to pharmaceutical products. BRICS countries are emerging markets with a partial regulatory system similar to well-regulated countries. BRICS countries have a registration or notification process for cosmetics based on their classification. A systematic review was carried out. We searched the databases and reviewed assessment agency websites, among other sources. Qualitative studies, official regulations, and systematic reviews aimed to identify a general framework of regulatory activity in BRICS were included. A critical analysis is made of all the aspects that may be useful for any public body that intends to register cosmetics in any of the BRICS countries. BRICS nations are organized to promote, stabilize and consistently regulate cosmetic products among them. The cosmetic regulatory system, registration process, and procedures of South Africa are at their last position, as Russia precedes South Africa. Cosmetic products are very well regulated and the registration process is well-defined in Brazil, China and India among BRICS. The registration process in BRICS countries is appropriate and slightly altered from one another, even though South Africa follows no registration process. BRICS are the world's fastest and largest emerging cosmetic market economies.
Keywords: Cosmetics, Regulations, BRICS, Emerging market
INTRODUCTION: Emerging markets are markets that have a few attributes of an already developed market but do not meet its standards completely. These markets might be developed markets or may become developed markets in the future. Both India and China were considered the largest emerging markets along with Brazil and Russia in 2006. The BRICS countries are one of the world's emerging markets. BRICS is an acronym for Brazil, Russia, India, China and South Africa. The term “BRIC” was coined by Goldman Sachs economist Jim O'Neill in 2001.
On December 24th, 2010, South Africa officially became a member nation as China invited them to join officially and other BRIC countries also accepted later. The NDB (New Development Bank) was founded by BRICS and will become a major regional development bank when cosmetics are regulated as equal to pharmaceutical products 1.
The creation of NDB suggests flexibility in governance to develop the BRICS role in global financial institutions. All of the BRICS are set to be essential to future growth.
Rapidly increasing disposable incomes mean consumers are shifting beyond solely purchasing basic products to more sophisticated beauty products. By 2050, these countries will become leading traders of production goods, amenities, and raw materials due to low production costs and labor 2. The objective of this study is to compare the cosmetic regulations followed by the BRICS countries; to study the growth of the BRICS countries in the cosmetic sector, and to study the impact of BRICS on the cosmetic industry.
TABLE 1: REGULATION AND REGISTRATION REQUIREMENTS FOR COSMETIC PRODUCT IN BRAZIL
TABLE 2: REGULATION AND REGISTRATION REQUIREMENTS FOR COSMETIC PRODUCTS IN RUSSIA
S. no. | Title | Content |
1 | Regulatory Authority | Rospotrebnadzor
MOH |
2 | Classification | Low risk and
High risk |
High risk | Pre-market state enrolment confirmation is required for the safety of the products. It takes nearly 90days to complete the State enrolment process as per Customs Union samples | |
Low risk
|
Low-risk products should be tried at an endorsed research facility in the Customs Union. Mostly safe cosmetic products are given by Rospotrebnadzor with an EAC presentation (statement of similarity) | |
3 | General requirements | The new legislation aims to harmonise and align with the necessities of cosmetic products in the Customs Union and the European Legislation. The Technical Regulation is related to the EU Cosmetics Directive 76/768/EEC and the present Cosmetic Regulation 1223/2009/EU. The Local Authorized Representative is responsible for products similar to the Responsible Person in the EU |
4 | Annexes | The Specialized Guideline records the precluded substances, limited substances, permitted colors/shades, additives, and UV channels with which the item equations should be in line, similar to the EU Guideline, but not by and large the same as the EU Guideline |
5 | Certificates | The State Registration of Customs Union
GOST R Declaration of Conformity |
Objectives of certification | Demonstrates item conformity to Customs' freedom systems, Russian cleanliness, and health requirements | |
Timeline
|
A declaration of conformity can be valid for 5, 6, or 7 years
The state registration doesn’t have any time limitation |
|
Documents Required | Application form, Declaration of conformity of the cosmetics to the EU guidelines, ISO certificate (if any), Certificate of Trade, copy of the agreement with the nearby wholesaler/shipment receipt (for the single shipment accreditation) and document signed by an outsider endorsing the security of items. Extra records might be needed during the confirmation system | |
6 | Label | Designation and address of the producer and company with a sign of the country.
Brand, if any, can remain in Latin letters Nominal content is given by volume (cm3 or ml) or weight (g) as well as amount, with the exception of 5 ml or 5 g List of elements in the dropping request as indicated by the INCI equation. Conditions, warnings, mark of conformity, leaflets, the expiry date with the EAC confirmatory mark 6 |
7 | Mark of Conformity (GOST R SIGN)
|
The GOST-R sign (Mark of Conformity) needs to be given on the cosmetic product, which shows that the product fulfils all the safety regulations and was inspected by a certification authority recognised by Rospotrebnadzor. This results in consumer satisfaction with product quality and safety. The size of the GOST R SIGN should not be less than 4 mm |
8 | Language | Russian. Only the composition (INCI) and the commercial trademark can be in Latin letters among the necessary markers. |
9 | Export/Import fees:
|
Expenses will often include the following items: Analyses and tests on products in accredited laboratories; Audit expenditures, including inspector travel fees and lodging (if applicable); Certificates are issued at no cost. translation services; Overhead expenses7 |
TABLE 3: REGULATION AND REGISTRATION REQUIREMENTS FOR COSMETIC PRODUCTS IN INDIA
TABLE 4: REGULATION AND REGISTRATION REQUIREMENTS FOR COSMETIC PRODUCTS IN CHINA
TABLE 5: REGULATION AND REGISTRATION REQUIREMENTS FOR COSMETIC PRODUCT IN SOUTH AFRICA
S. no. | Title | Content |
1 | Regulatory Authority | SABS, SAHPRA, CTFA, Coschem |
2 | Regulatory framework
|
The Department of Health structures cosmetics via the Foodstuff, Cosmetic & Disinfectant Act (Act 54 of 1972) and equal guidelines. This Cosmetic Code is assembled and overseen by the industry, through the CTFA and submitted to the ARB for incorporation into their code. There is an in-market control framework rather than a pre-market control framework. |
3 | Role of RA -
SABS |
The SABS qualified the SANAS. Norms Act, 2008 and started up the SABS as the public launch for the improvement and support of standardisation and quality of goods. |
CTFA | To improve reputed regulations and guidelines, Create the ideal financial and administrative working atmosphere by supporting best practise and taking responsibility. Adjust and improve South Africa with worldwide administrative principles. Advance social obligation through the exercises of the Look Great, Feel Better program. | |
Coschem | Advance the progression of science and innovation in the beautifying products and toiletries industry. Advance the high moral guidelines of corrective science. Give the means to the dispersal and trade of information appropriate to corrective science. Energize research in surface-level sciences. | |
4 | Application forms | DA185 - Enrolment/Authorizing of Customs and Excise Customers.DA185.4A1 - Enrolment Customer Type 4A1 – Merchant. DA185D - Selection of Specialist. |
5 | Medical Control Council (MCC) | Any item joined by recuperating or restorative cases should be enrolled at the MCC, and any item joined by thinning or muscle improvement claims should be enlisted at the MCC. |
6 | Registration | Cosmetic products are not subject to registration, but here they follow an in-market system of control rather than a pre-market system of control. All the formulas that contain alcohol must be registered with the Department of Customs and Excise for duty rebate on alcohol usage, especially for products that are manufactured in South Africa 11 |
7 | Label | Assertions are “Result of [insert nation of origin]” assuming all components are from that nation, or “Delivered in [insert nation of origin]” if the components utilised are from an unexpected country in comparison to the country where the items were mass-produced.
The label should contain the date produced, cassation date, the name and address in South. Africa of the producer, shipper or wholesaler, group number, item weight, and units. Components with the name "Ingredients" toward the beginning of the list, recorded in the dropping request of mass. Names should be in English. 12 The list of components should incorporate the names of any additives or colorants utilized. The additive or colorant's name or number can be utilized, yet the number is discretionary. Dietary tables should show up on the mark, assuming that the item makes a nourishing case. The table should give the supplement amounts per serving, or per holder size. All supplement amounts should be recorded in SI units. There may be no deceptive cases on the names. Items may not contain any prohibited elements, for example, hydroquinone (a skin lightener) |
RESULT AND DISCUSSION: As an emerging market, BRICS is currently focusing on regulating cosmetic products to compete with Western markets and grow economically. BRICS countries have to deal with so many regulatory factors since they lag behind in regulations for cosmetic products. BRICS is an acronym that brings five different nations under one roof, but it’s actually challenging to achieve equal growth in the cosmetics market due to different manufacturing processes, climatic zones, labour, financial support, government and supply chain among them. The traditional pharmaceutical and cosmetics markets are small in these five nations. As of now, synthetic and semi-synthetic products have a fastened effect in the cosmetics department, which pushes other parts of traditional cosmetics behind. Even though the growth of BRICS’ cosmetics sales is gentle, it is moving all the way to attain huge economic growth in the cosmetic market. BRICS's aim is to become parallel, economically steady and identical to that of developed countries. Among BRICS countries, the population in China and India is greater, so the use of cosmetics and other beauty products is also greater in these two countries. Thus, cosmetics sales are gradually increasing in China and India. Guidelines and regulations for cosmetics products are not framed as stringent as pharmaceutical products’ regulations. Cosmetic products must be given equal importance and perfect regulations to enter the BRICS pharmaceutical market. The geographical barriers, longitudinal and latitudinal extent of BRICS differ, and it is challenging to frame harmonised regulations and guidelines. The regulators must consider the differences in origin, genetic makeup, size and other factors that challenge them due to the underdeveloped regulatory system. The changes in China and India’s population and economy change the country's epidemiological profile. The variation is particularly wide between HIC and LMIC with different regulatory frameworks. The New Development Bank (NDB) is another notable achievement. BRICS is also discussing a framework for BRICS e-commerce cooperation to promote cross-border e-commerce. This new world of e-commerce will bring changes in cosmetic products too 13. The growth of BRICS is compared to the US and EU markets because of the market size and their promising potential role in the pharmaceutical industry.
The BRICS countries worked hard to improve coordination and establish themselves in a variety of initiatives. They functioned together to stabilize the global financial system through CRA, where countries have decided to offer short-term liquidity support through currency swaps to help with any external contingency. BRICS nations have also banded together to promote, stabilize and consistently regulate cosmetic products 14.
Considering the above information on cosmetic regulatory systems and other beauty product registration processes and procedures, South Africa is in the last position, as Russia precedes South Africa. Cosmetic products are very well regulated, and the registration process is well defined in Brazil, China, and India among BRICS.
CONCLUSION: The purpose of this study was to compare the registration process of cosmetic products and to find out the variances and gaps among the guidelines. The registration process in BRICS countries is appropriate and slightly altered from one another, even though South Africa follows no registration process. BRICS are the world's fastest and largest emerging cosmetic market economies. They are the largest entity on the global stage of cosmetic products. The drawbacks in Brazil, Russia, and China are that the regulations are in their local languages, and the documents required for cosmetics registration should be translated into their local languages, such as Brazilian, Russian and Chinese, respectively. It takes a lot of time to understand the rules and regulations and for the registration of one cosmetic product. To rectify the differences in the guidelines, we need to go for harmonisation of rules, which is also a time-consuming process. But once these guidelines are harmonized, emerging countries like BRICS will benefit even more. We can expect a common guideline worldwide for cosmetic product registration. It can be concluded that the BRICS countries are presenting optimistic growth and direct global investment by creating significant opportunities for cosmetic companies to expand into the world cosmetic economy.
ACKNOWLEDGEMENT: We would like to thank all of the authors of the research publications that we used for the systematic review.
CONFLICT OF INTEREST: None
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How to cite this article:
Sathyalakshmi R, Jaipratap N and Sowmya C: The current registration regulations of cosmetic products in “Brics” countries. Int J Pharm Sci & Res 2023; 14(4): 1660-67. doi: 10.13040/IJPSR.0975-8232.14(4).1660-67.
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IJPSR
R. Sathyalakshmi, N. Jaipratap and C. Sowmya *
Department of Pharmaceutical Regulatory Affairs, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, India.
drcsowmya@sriramachandra.edu.in
19 July 2022
30 August 2022
28 October 2022
10.13040/IJPSR.0975-8232.14(4).1660-67
01 April 2023