*EU, Norway, Ukraine, Israel, Thailand, China and Eurasian Economic Union.

FDA Registration (Thailand)

Provide services for FDA registration by certified FDA Specialist.

Provide services for preliminary data screening before filing the application forms in order to reduce problems due to rejection of FDA registration, with the following information for the application.

1) Brand name (trade name)

2) Product name (merchandise name)

3) Photos of packaging clearly stating brand names and product names (PDF File)

4) Detailed formula, properties, or special extracts of interest to be manufactured by the Company

Safety data sheets and labels

The REACH regulation requires chemical manufacturers, importers, blenders and traders to deliver up to date safety data sheets (SDS). SDS’s must be compiled according to the detailed requirements for the content and format given in the regulation.

Safety data sheet is a legal document and the supplier of the product is responsible for the contents of the SDS. SDS’s must be delivered free of charge in the official languages of the receiving country at the latest the day the product is delivered to the customer.

Labelling

The contents of the warning label are precisely set in the CLP regulation. The label must show all the relevant information about the hazards of the product as well as the safe use of it. Labelling needs to be in line with the labelling given in the SDS. Transition to the CLP classification in labelling is quite a large project since it involves not only labels, but SDS’s as well.

We provide following services

compiling safety data sheets

compiling warning labels

SDS and label translations: we are able to provide SDS’s and labels in all EU languages, and also, for example, in Norwegian, Croatian, Ukrainian and Russian languages

submitting chemical notifications to Finnish Safety and Chemicals Agency

making REACH notifications to the European Chemicals Agency ECHA

the interpretation and application of the exposure scenarios

Certificate of Free Sale (CFS)

Provide services for filing the application with the Federation of Thai Industries for the Certificates of Free Sale, as the services are provided for the members of the Federation of Thai Industries only.

Stability testing

The product under inspection is held at three different temperatures (5 °C, 23 °C and 40 °C) usually for 4 months. This will give the stability validation for 12 months. To get longer validation for stabilization the inspection period may have to be extended.

Microbiological challenge test

This test is executed under the requirements of European Pharmacopeia (Ph. Eur 5.1.3). Completing this

test takes 2 months.

Compiling Product Information File (PIF)

Includes: Product description, Cosmetic Product Safety Report (CPSR), GMP authentication, proof of claimed effects, data on animal testing

Responsible person Service

Usually, the manufacturer or importer assumes the identity of the “responsible person”. The distributor within the European Economic Area (EEA) could also be required to take on the role of the responsible person, if they place a cosmetic product on the market under their own name or trademark or if they modify a product already on the market. Alternatively, the manufacturer or importer may authorize a representative to act on their behalf as a responsible person. A foreign manufacturer cannot act as a responsible person on their own within the EEA. The obligations of the responsible person are to ensure that the product is safe for its intended use and that it is used in a safe way and to ensure that all requirements under the regulation are fulfilled. The obligations are detailed in articles 4 and 5 of the Cosmetics Regulation.