Mar 2015

5 Common Mistakes: Interpreting Cosmetic Regulation (EC) No. 1223/2009 and GMP ISO 22716

Confusion still prevails within the cosmetic industry in how to interpret Cosmetic Regulation (EC) No 1223/2009 and the associated GMP ISO 22716 and the implications of compliance for daily workflow. To follow are five common causes of confusion that tend to occur in interpreting these regulations and good manufacturing practices:

1. Regulation (EC) No 1223/2009 - PIF requirements

Article 11.1 of the EC regulation states:When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it.” A compliant product information file (PIF) therefore must be created from the date the cosmetic product is first sold and for a duration of 10 years from the date when the product is last sold. Whilst the regulation states that the PIF may be delivered 'within 72 hours' of a request made by an authority, many companies still ignore the requirement for creating compliant PIFs at the time the product is placed on the market, assuming instead that it is sufficient to create them 'on demand'.

See also the following article on PIF software.

2. Compliance with Cosmetic Good Manufacturing Practice ISO 22716

Under the article 11.2.c, the PIF must contain "a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8". As a reminder, article 1 states: "This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health."

Although the PIF only requires a simple declaration of compliance with Cosmetics Good Manufacturing Practice ISO 22716, it is in effect a central pillar of the regulation, with wide-reaching implications for cosmetics businesses, including the requirement to:

  • identify all raw materials and suppliers for each product batch (para. 6.4.4 &;
  • maintain effective documentation (para. 17.1.2);
  • operate effective change control procedures (para. 15).

3. PIF must be kept updated - (EC) No. 1223/2009

Cosmetics Regulation (EC) No 1223/2009 states "The product information file shall contain the following information and data which shall be updated as necessary". The PIF is a 'living document' - changes to a product's specification must be documented and all files comprising the PIF kept up to date.

4. Trace-ability across batch changes  (GMP ISO 22716)

Throughout the lifespan of a product changes can occur - ranging from small adjustments to the manufacturing and storage method, to formula changes. You will need to consult with your safety advisor as to whether a change is considered significant enough - such as a reformulation - to require the production of a new PIF. Changes of raw materials batches and suppliers will inevitably occur between batches of your product. Whilst it is in most cases unlikely that this would require a new PIF to be created, the exact batches of each raw material, associated documents (e.g. CoA and MSDS) as well as supplier information must be traceable to each and every batch of your product. This is best achieved by producing batch reports/protocols which serve as 'snapshots' of your product's batches and serve as supplements to your main PI file.

Download auto-generated batch protocols using Cosmetri Product Manager:

GMP ISO 22716 batch traceability

5. Requirements extend beyond CPSR (A+B)

Whilst comprehensive, Parts A and B of the Cosmetic Products Safety Report (CPSR) as supplied by a qualified safety assessor do not serve as a substitute for a PI file, which must include the CPSR as well as additional information, as follows:

- Product description (Article 11.2.a)
- Method of manufacture and a statement of GMP compliance (Article 11.2.c)
- Proof of effect for the product (Article 11.2.d)
- Data on animal testing (Article 11.2.e)

Almost two years after the deadline for complying with Cosmetics Regulation (EC) No 1223/2009, many cosmetics businesses seem only to be partially compliant. Business owners need to be better informed and take the necessary steps to implement processes and practices that ensure continued compliance and above all, safety for the consumer.


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