Safety report of cosmetic products

The basic things are specified in the EU Cosmetics Regulation 1223/2009, which can be found under the link in the references below.¹

An important point of the obligations of the responsible person, which are stipulated in Article 5 of Regulation 1223/2009, is, among other things, keeping a so-called product information file.

Product information file

This is created at the beginning or before the cosmetic product is placed on the market and is managed and maintained at the point of placing on the market over the entire life cycle of the product. In addition, it must be kept for ten years after the last batch was placed on the market.

The product information file must be presented to the authorities for inspection at the place of placing on the market and must be created in a language that is easily understandable for the competent authorities.

The product information file (PIF) contains all the data that describes the cosmetic product. In addition to a description of the cosmetic product and a description of the manufacturing method, this also includes all other points that belong to the product, such as the recipe, the raw materials used and their composition and impurities, the microbiological condition and stability of the product, proof of effectiveness, GMP certification, packaging data, data on incompatibilities, etc. An essential part of the product information file is the safety assessment of the cosmetic product. (Article 10 of Regulation 1223/2009)

Safety assessment

The safety assessment can only be carried out by a person who is appropriately qualified in accordance with Article 10 (2) of Regulation 1223/2009. These are natural scientists with chemical, food chemistry, toxicological or other similar training. The structure of a safety report is basically explained and described here in the Commission Implementing Decision of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Text with EEA relevance.²

Annex I of Regulation 1223/2009 is an important orientation. According to this annex the safety assessment is divided into two parts. Part A, the safety information about the cosmetic product and Part B, the safety assessment of the cosmetic product. Part A contains the safety information on cosmetic products:

• Quantitative and qualitative composition of the cosmetic product
• Physical/chemical properties and stability
• Microbiological quality
• Contamination/traces and information on the packaging material
• Normal and reasonably foreseeable use
• Exposure to the cosmetic product and substances
• Toxicological profiles of the substances
• Adverse effects and serious undesirable effects
• Further information about the cosmetic product

In Part B, a final safety assessment of the cosmetic product is created, which consists of:

• Conclusion
• Warning and/or usage information
• Reason
• Qualification of the evaluator

In the everyday life of a safety assessor, questions arise from time to time, because the safety assessor is responsible for the safety of the product.

Avoiding pitfalls

There are some “pitfalls”, especially when it comes to the necessary documentation that must made available to the safety assessor:

• The recipe: Here it is important that the recipe lists all substances that are used in a cosmetic product. What is really in the finished product? Even the smallest amounts must be listed here.
• The stability: What is the shelf life of the product? Statements like “the product has been on the market for a long time” are not enough here. How was that proven and documented? And how is it proven that the product is just as stable after a storage period as it was at the beginning?
• The microbiology: A very important point is, in addition to the basic batch control, the preservation stress test. Statements such as “I work cleanly” or “I do not use preservatives” are not sufficient here either. The so-called “preservation stress test” proves that the product remains stable and intact after use by the consumer and is also legally required for most products.
• The raw material data: “I use groceries, the label is enough” and “The label is enough for other evaluators”, unfortunately that is not enough either. For example, stabilisers and preservatives must be known like other contaminants.
• The packaging: “It has been in use for a long time, the packaging is ok.” Here, too, there must be a corresponding receipt to guarantee the safety of the cosmetic product. A drawing or a safety data sheet for the packaging is not enough.

These are just a few examples of what the safety assessor must observe and what the responsible person is obliged to do. In addition, there are always further questions, because every cosmetic product is different. And the requirements are also very different, so that the safety assessor will question the manufacturer from time to time. So, get detailed advice and persevere, especially in the documentation, because that will bring a safe product.

References:

¹ EU Cosmetics Regulation 1223/2009: https://eurlex.europa.eu/legal-content/DE/TXT/?uri=celex-%3A32009R1223#d1e954-59-1

² Commission Implementing Decision of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Text with EEA relevance: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX-:32013D0674