Pharmaceutical & Cosmetic Review August 2019

Page 34

REGULATIONS, LEGISLATION & TESTING

How to compile a Product Information File In accordance with Regulation 6(1), a PIF should be compiled for each cosmetics product manufactured. The PIF must include all of the necessary particulars relating to the identity, quality, safety to human health and the effects claimed for the product. By Anina van der Walt of

T

Lumen Regulatory Solutions he cosmetics industry is well aware of the draft regulations of the South African Foodstuffs, Cosmetics and Disinfectants Act,

1972 (Act no. 54 of 1972), relating to the Labelling, Advertising, and Composition of Cosmetics, R. 1469. The draft regulations were published in August 2016 and again redrafted for industry comment in December 2017.

The process to compile a PIF should not cause trepidation, although it currently does

3. The Product Composition (and Manufacturing Method) section should include qualitative and quantitative formulation information. This includes the trade name, INCI name, function and percentage of the ingredients used. This is also a relevant section to indicate the ingredients included in the product comply with legislative requirements

Regulation 6(1) states ‘…The Responsible

PIF structure explained

where restrictions or permitted use

Person, prior to placing a cosmetic

For illustrative purposes, a PIF should

apply. The manufacturing method of the

product on the South African market and

contain the following sections and data.

product and process description should

for control purposes, must keep a Product

1. It is advised the section on

Information File (PIF) for each cosmetic…’. Since local cosmetics legislative

4. For packaging (specifications)

contain all the relevant basic

and labelling it is important to note

promulgation did not occur and

company information, such as a

enforcement rules are not yet

contact person, physical address and

recognised, product owners are either

also be noted.

administrative information should

contact details, including:

the following: • packaging type identification (pump, spray, tube or jar etc.)

cautiously starting to collect information,

• product owner

• pack size specification

or they’re unsure of where to start.

• responsible person (RP)

• type of packaging, primary packaging

The latter is a ‘buried head in the

• manufacturer and the manufacturer

sand approach’ in the hope a PIF will

statement of relevant GMP compliance

neither be required nor requested by a

• market distributor (where applicable)

regulatory authority.

• importer (where applicable). 2. Even though some of the product

material specification and composition, including technical substances • identification of technically unavoidable impurities • information about the packaging

Don't fear the PIF

information included in the Product

The process to compile a PIF should not

General Information section may

• for primary packaging, it is beneficial

cause trepidation, although it currently

seem obvious to the brand owner,

to provide a ‘Food or Pharma Grade’

does. A review of the legislative aspects

the PIF should also be structurally

followed in various other countries reveals

set out to assist with either a product

or applicable.

the process to compile a PIF should be

evaluation or the safety assessment,

5. The physico-chemical and

clearly structured and planned.

as required. The following information

microbiological specifications of

may be included:

raw materials are important. The

The idea is not to reproduce another technical document using all and

• target population (healthy women,

sometimes irrelevant information. PIF

men, adults, children, shaving adults,

objectives are to identify the cosmetics

middle aged woman etc.)

product, determine the quality, establish

• intended use and general purpose

material (SDS, TDS and COA)

statement where available

information in the raw material or ingredient specification section should typically include: • identification of nano materials

safety to human health and the effects

(body lotion, face cream, or

where applicable

claimed for it to create a dossier

shampoo etc.)

• physico-chemical

applicable to a specific product and formulation type. The PIF should contain data and information in a format that is practical to maintain throughout the product lifecycle (and after). It should be compiled in such a way that it’s easily reviewed by an evaluator.

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| AUGUST 2019 | P C Review

• main action (e.g. cleansing, antiwrinkle, or depilating) • formulation type (an emulsion, cream, butter or oil etc.) • the type of exposure (Leave-on or rinse-off) • foreseeable application area (body, face, or hands etc.).

ingredient specifications • supplier information including the Safety Data Sheet (SDS), Certificate of Analysis (COA) and IFRA certificate (where applicable) • microbiological specification of the raw materials supplied by the manufacturer of the raws


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