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