There are different filing procedures and requirements for cosmetic product compliance across the globe and certain markets put forward very specific requirements that evolve constantly. To safeguard the launch of a cosmetic product in specific markets, companies should be well versed with various Regulatory forms, from cosmetic classification, to complex cosmetic registration/notification procedures and filing requirements of respective regions.
Tracking down each geography’s Regulatory requirements is time-consuming and tedious for stakeholders and failing to do so may deter business expansion plans. In such a scenario, opting for an exclusive cosmetic global Regulatory service provider may help in streamlining cosmetic compliance activities, and thus, mitigate compliance risks and reduce the time-to-market.
Freyr, owing to strategic partnerships throughout the globe, can provide end-to-end support to ensure the cosmetic products comply with varied region-specific regulations. Freyr not only helps in understanding cosmetic product regulations of different markets but also provides streamlined Regulatory strategies to comply with the country-specific regulations. Freyr leverages its expertise in delivering end-to-end cosmetic Regulatory services for product authorization process and assist cosmetic companies throughout the cycle.
- Product Classification: In some countries, Health Authority mandates the classification of cosmetic products to enter specific market. Sometimes, Regulatory classification of cosmetic products is necessary to determine the category of borderline products.
- Legal Representation: In most of the regions like the ASEAN, Middle East, EU, it is mandatory to have a local responsible person who ensures compliance of cosmetic products with the specific requirements of their Regulatory bodies before and after they are placed in the market.
- Material Safety Data Sheet (MSDS) – MSDS (referred to as SDS in Europe) is an essential tool for chemical risk management which entails identification, hazards, composition, handling, safe work conditions, etc. of a given chemical substance or a mixture. It should be provided in the local language of the target country.
- Product Information File (PIF) – PIF is a mandatory document that is necessary for every cosmetic product placed in the Association of Southeast Asian Nations (ASEAN) and European markets. It contains all the key information of the finished product ranging from product description to animal testing performed. PIF is maintained by the person responsible for placing the product in the market and is made available to competent authorities during audit.
- Cosmetic Product Safety Report (CPSR) – CPSR is a mandatory document that is required to be maintained as per the guidelines of The Association of Southeast Asian Nations (ASEAN) and The European markets. It is a scientific review document and is prepared by a qualified person upon performing safety assessment of the product. This is the most important and extensive part of PIF.
- Audit Representation – The health authorities of few markets like ASEAN, shall monitor compliance of cosmetic products through Post Market Surveillance (PMS) programme after the products are placed in the market. The audit shall comprise screening of product formulation, sample collection and testing, audit of premises for compliance to the cosmetic GMP, audit on PIF etc.
- SUGAM – SUGAM is an online licensing portal in India through which requests for various services like, processing and grants of permission are filed for varied range of products including cosmetics, medicinal products, medical devices etc. Any Indian agent, importer, foreign enterprise holding Indian subsidiary only can register with SUGAM.
- Dossier Preparation – In India, cosmetic product registration certificate (Form 43) is obtained by submitting Form 42 along with a dossier which consists of a wide variety of technical documents like formulation, product label, specification etc., administrative documents like Letter of Authorization (LOA), and Regulatory documents like manufacturing license, Free Sale Certificate (FSC) etc.
- eCosma – In Saudi Arabia, the SFDA has introduced an electronic notification system called eCosma for cosmetic products to regulate notification, manufacturing, licensing, and clearance of products. Active since 2015, eCosma brings with it an ease of cosmetic notification system. However, confusion prevails due to unclear guidelines. Importers and suppliers are required to implement this compulsory practice. eCosma is focused on establishing the traceability of cosmetic products in Saudi market during the market surveillance carried out by respective agencies.
- License to Operate (LTO) – In the Philippines, all establishments that engage in manufacturing, importation, distribution and trade of cosmetics shall mandatorily secure an LTO, which should be renewed before its expiry, as per the guidelines.
- Cosmetic Notification to Health Canada – As per the section 30 of the Cosmetic Regulations, manufacturers and importers must notify their cosmetic products to Health Canada within 10 days of being placed in the market, through online submission of Cosmetic Notification Form (CNF). Failure to notify may result in a product being denied entry into Canada or removed from sale. Also, any change to the information provided in the CNF or discontinuation of sale of cosmetic products, manufacturers and importers must be notified to Health Canada by submitting an amendment to the CNF within 10 days of the change.
- Voluntary Cosmetic Registration Program (VCRP) – The US FDA’s VCRP is a voluntary reporting system for the manufacturers, packers, and distributors of cosmetic products. This program includes the submission of Form FDA 2511 for registering cosmetics, manufacturing and/or packaging establishments and Form FDA 2512 for filing Cosmetic Product Ingredient Statements (CPIS). Either Form FDA 2511 or Form FDA 2512 or both can be submitted by the manufacturer.
- California Prop 65 – Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. The proposition protects the state's drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals. The ingredients in the formulation can be cross-checked against the Prop 65 list. Safe levels of any listed ingredients if present in the formulation, can be determined using the safe harbor levels like No Significant Risk Levels (NSRLs) for Carcinogens and Maximum Allowable Dose Levels (MADLs) for Chemicals Causing Reproductive Toxicity.
- California Safe Cosmetic Program (CSCP) – The California Safe Cosmetics Act requires companies that manufacture cosmetics to report any cosmetic products that contain ingredients known or suspected to cause cancer, birth defects, or other reproductive harm. All the ingredients in the formulation can be cross-checked against the reported ingredients in the database to find out if it contains any of those ingredients and the data can be submitted to CSCP using online reporting system. The data is made available to the public through this website.
- Japanese Labeling Name of Cosmetic Ingredients – In Japan, an application for obtaining Japanese Labeling Name for cosmetic ingredients must be made to Japanese Cosmetic Labeling Name Nomenclature Subcommittee (JCIA). This can be applied for ingredients that already have an International Nomenclature of Cosmetic Ingredients (INCI) or in the process of obtaining it. The applicant applying for the Japanese Labeling Name must be engaged in the manufacture, import or marketing of cosmetics, irrespective of whether they are members of Japan Cosmetic Industry Association or not.
- Existing Inventory of Cosmetic Ingredients in China (IECIC) – Various APAC countries follow specific regulations to strengthen the safety management of cosmetic ingredients. Likewise, Chinese Food and Drug Administration (CFDA) has developed IECIC to approve new cosmetic ingredients for use in cosmetics.
- Act on the Registration and Evaluation of Chemicals (AREC), (K-REACH) – AREC, also known as K-REACH, lays down the requirements for registration, hazard evaluation and risk assessment for manufactured and imported new & existing chemical substances, and products containing hazardous substances in Korea. The responsibility for fulfilling K-REACH registration lies with the corresponding importers established in Korea, or with the Only Representative (OR) based in Korea.
- Swiss ChemO – Switzerland, not being a member of the EU or the European Economic Area (EEA), it has its own chemical regulations on protection against dangerous substances and preparations, also called Swiss ChemO or the Swiss Chemicals Ordinance. It implements classification, labelling and packaging (CLP) and REACH-like registration requirements for new substances placed on the Swiss market.
- End-to-end cosmetic Regulatory services
- Qualified team of experts with hands-on experience across all categories of cosmetic products
- Support for region specific Regulatory complexities
- Extensive partner network across the globe
- Strong relationship with the health authorities
- Structured and cost-effective approach to ensure quick market access