PIF requirements in focus

On 18 July, Coschem hosted a midday lecture at Evonik in Midrand, Johannesburg on GHS, SDS and PIF requirements for the cosmetics and personal care industry. Registered professional scientist and the local representative for Lisam Systems, Belinda Berry shared her extensive expertise on these topics.

The cosmetics industry is facing a period of transition from self-regulation to enforced regulation by the Department of Health. While the regulations have not yet been promulgated, the draft regulations are largely based on requirements for the EU. To bring industry up to speed on certain necessities within these proposed regulations, Berry focused on the structure and definitions of a product information file (PIF), the minimum information required for a PIF and safety assessment requirements, all according to the EU regulations, as well as basic GHS and SDS requirements in South Africa and the differences globally in terms of GHS.

The draft regulations for PIF requirements (Section 4) match those of the EU, yet Berry advised this could change with promulgation. A fixed format is required for the PIF, which is made up of two parts, being A and B. Section A contains the information on the product including exposure to the product, the toxicological profile, physical and chemical data, microbiological testing and claims support. Part B is the Cosmetic Product Safety Report (CPSR), which includes the assessment conclusion, label requirements, and the assessor’s credential. If the product is assessed safe, it is then signed by the safety assessor.

The PIF is not a public document because it contains sensitive information and IP. However, the responsible person must also have access to the PIF. For brands exporting to the EU, the PIF is important from a distributor perspective but does not need to be disclosed to the distributor as long as the PIF is available at the address on the label’ she explained. ‘The PIF must also be in the native language of a state where the product is being sold.’

CRUCIAL AND COMPLEX

The CPSR is a vital and complex section of the PIF. In essence, it confirms the product is safe for use. The CPSR consists of the following parts:

• A – safety information
• B – safety assessment
• the method of manufacturing
• evidence of GMP compliance
• any product claims and the substantiation thereof
• data on animal testing – confirmation is required that the product has not been tested on animals

The CSPR needs to be completed and signed off by an expert in the field of toxicology. The PIF is kept by the responsible person (typically the business owner/ manufacturer) at an EU address. It can be electronic or in any other format and needs to be easily accessible. It should be kept for 10 years after the last batch of products has been produced. ‘A lot of data is required to complete the CSPR, such as the composition, stability, micro testing, quality and impurities such as heavy metals or pesticides. The type of manufacturing process is also key in terms of the impurities and quality of a product. Making this information available to the safety assessor is crucial to the outcomes of the safety assessment,’ Berry added.

Coschem hosts regular lectures, seminars and networking events. For more information on these events, send an e-mail to bridget@coschem.co.za.