GLOSSARY for Cosmetic Guideline

User Rating: 0 / 5

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive
 

Cosmetic Notification Holder (CNH)

The CNH refers to a company who is responsible for placing the cosmetic product in the market.

The CNH must be a locally incorporated company or legal entity in the field of cosmetics, with permanent address and registered with Companies Commission of Malaysia (with the scope of business related to the health/cosmetic product as it appears in the `Memorandum and Article of Association’ of the company)

The CNH may or may not be the product owner.

 

Cosmetic Product

A cosmetic product shall mean “any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”.

For the illustrative list of cosmetic product by categories, please refer to Annex I, part 1.

 

Letter of Authorisation (LOA) / Letter of Declaration

A Letter of Authorisation (LOA) is issued by the product owner including the list of products or brands authorising the CNH to notify the products with the NPRA and be responsible for all matters pertaining to product notification if the CNH is not the product owner. 

On the other hand, if the CNH is the product owner, a Letter of Declaration must be produced which state the ownership of brand name including the list of products or brands for the product notification with the NPRA.

 

Letter of Contract Manufacturing

Contract appointment and acceptance letters between product owner and contract manufacturer(s) describing the product name(s)/brand(s) involved and the role and responsibilities of both parties. 

 

Manufacturer

A manufacturer is a company which is engaged in any process carried out in the course of making the cosmetic products. The manufacturing process includes all operations of purchase of starting materials, bulk intermediates and products, formulation and production (such as grinding, mixing, encapsulation and/or packaging), quality control, release, storage and distribution of cosmetic products and the related controls.

 

Primary Assembler

A primary assembler is a company which is engaged in a process of enclosing the product in a primary/intermediate container which is labelled or to be labelled before the product is sold or supplied in it.

 

Secondary Assembler

A secondary assembler is a company which is engaged only in a process of labelling the product container where the product is already enclosed in its primary container and/or packing the product which is already enclosed in its labelled primary container into a carton which is labelled or to be labelled, before the product is sold or supplied.

 

Product Name

A name given to a cosmetic product, which may be an invented name, together with a trade mark or the brand name.

Examples of non-permissible product name for cosmetic product are listed in Annex I, part 2.

 

Product Owner

A product owner is a company or entity who is the legal and/or registered owner of the product formulation and/or process with whom the CNH has a contract.

 

Product Variant

Product variants shall mean items in a range of cosmetic products which are produced by the same manufacturer, similar in composition and are intended for the same use but are available in different colours, fragrances or flavours. In this context:

  • Colour shall mean, a substance used as an ingredient of a cosmetic product solely to give tonality to the product;
  • Fragrance shall mean, a substance used as an ingredient of a cosmetic product solely to impart odour to the product
  • Flavour shall mean, a substance used as an ingredient of a cosmetic product solely to impart taste to the product.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

© Copyright 2018 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA