Overview

Across the globe, there exist different filing procedures and requirements for Cosmetics compliance and certain markets put forward very specific requirements that constantly evolve. To safeguard a cosmetic product launch or registration across the globe or in specific markets, companies should be well versed with various Regulatory forms, complex registration procedures and filing requirements in respective regions.

Tracking down each geography’s requirements is time-consuming and tedious for companies and failing to do so might deter those companies’ 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.

We, at Freyr, owing to our strategic partnerships throughout the globe, can provide you with end-to-end support to ensure that your products comply with varied specific regulations for different markets. We not only help you understand how your products are regulated in different markets but even provide you with solutions on how to comply with the same and further provide complete one-stop Regulatory support. Also, we leverage our expertise to deliver end-to-end project planner preparation services for the notification process and assist organizations throughout the lifecycle. This includes everything, right from sending e-mails for notification to FDA- Center For Cosmetics Regulation and Research (CCRR) and the assessment form to CCRR, to catering to the post-market surveillance services which further helps you in the smooth expansion of your business endeavours. 

 

Freyr Expertise

  • CLP Regulation - CLP Regulation on the Classification, Labelling and Packaging of substances and mixture is another emerging requirement in the EU which impacts chemical raw materials that are used to manufacture cosmetic products. If you import chemical raw materials to manufacture cosmetics products, you shall classify, label and package the substances or mixtures in accordance with CLP.
  • REACH - REACH also is a EU regulation concerning the Registration, Evaluation and Authorization of Chemicals. Both chemical raw materials and finished cosmetics products are impacted by REACH.
  • MSDS and SDS - The Material Safety Data Sheet (MSDS [referred to as SDS in Europe]) is the essential tool for chemical risk management. The safety data sheet is a document containing 16 sections related to the identification, hazards, composition, handling, storage, transportation, waste disposal and the safe work conditions, etc. of a given chemical substance/mixture. The MSDS must be provided in the local language of the country where the product will be used.
  • Swiss ChemO - Switzerland, not being a member of the EU or the European Economic Area (EEA), 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.
  • Existing Inventory of Cosmetic Ingredients in China (IECIC) - To strengthen the safety management of cosmetic ingredients, various APAC region countries follows specific regulations. Existing Inventory of Cosmetic Ingredients in China (IECIC) which is used by Chinese Food and Drug Administration (CFDA) is to approve a new cosmetic ingredient to be used for cosmetics production.
  • The Act on the Registration and Evaluation of Chemicals (AREC), (K-REACH) - Korea has The Act on the Registration and Evaluation of Chemicals (AREC), also known as K-REACH, which lays down the requirements for registration, hazard evaluation and risk assessment for manufactured and imported new chemical substances, existing chemical substances, and products containing hazardous substances. The responsibility for fulfilling K-REACH registration lies with the corresponding importers established in Korea, or with the Only Representative (OR) based in Korea.
  • Halal Certification - Another important aspect in cosmetics registration is the Halal Certification wherein the products must comply with the standards of the World Halal Council (WHC), a federation of Halal certifying bodies worldwide. For the cosmetics and personal care products that require Halal certification, the products must comply with the specific national standards as well as Islamic Sharia Laws which ensure no pork or pork by-products as well as alcohol are used in the product. Halal Certification is an assurance that a product has been thoroughly investigated and found to confirm to the Islamic Sharia Laws and is therefore, suitable for use by Halal Consumers.
  • ePhillippines - In Philippines, with an aim to regulate import, manufacturing, and marketing activities of cosmetic products, the FDA Center for Cosmetic Regulation and Research (CCRR) has introduced an electronic notification system called ePhillippines. The system has been active in Philippines since March 2013 to streamline the cosmetic notification application process by updating the submission of application requirements from manual forms to online submissions.  The purpose of electronic notification of cosmetics is to establish traceability of cosmetic products placed in Philippines.
  • eCosma - Similarly, in Saudi Arabia, the SFDA introduced an electronic notification system called eCosma for cosmetic products that regulates notification, manufacturing, licensing, and clearance of products. Being active since 2015, eCosma brings with it an ease of 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 the Saudi market during the market surveillance carried out by respective agencies.
 

Freyr Advantages

  • Cost-effective
  • End-to-end cosmetic Regulatory consultation
  • Qualified team of experts with hands-on experience across all categories of cosmetics like skin care, hair care, infant care, oral care, beauty products
  • Support for region specific Regulatory complexities
  • Extensive partner network across the globe
  • Strong relationships with different Health Authorities (HAs)
  • Structured approach to ensure quick market access