To make the most out of one’s appearance people fall back on care and beauty products. So that the contents of the jars, tubes and co. can be used carefree, the cosmetic manufacturers have to permanently control and document all production steps. This also applies for KHK, which manufactures around 10 million lipcare products annually.
With a total surface of up to two square metres, the skin is the largest organ of our body. It accounts for around one sixth of our weight, covers us almost completely and carries out several important functions: It supports the regulation of the body heat, protects the organism against outside influences such as pressure, shocks or chafing, wards off pathogens and serves to take in sensory stimuli. Furthermore, our body surface is a true regeneration ace: It completely renews itself every 30 days. New tissue forms continually which has a significant influence on our individual appearance – which is why many people invest ample time and even more money into caring for their skin. But who guarantees the harmlessness of the creams, lotions and soaps? The essential demands and obligations have been regulated European-wide by EC Cosmetics Regulation No. 1223/2009 since November 30, 2009. “Cosmetic product” means “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours” (Art. 2, para. 1a of the EC Cosmetics Regulation).
Carolin Haverkamp and Dr. rer. nat. Sivatharushan Sivanathan from the company KHK, which specialises in the contract manufacturing of lipcare products, are experts on the legal regulations. As Private Label Team Leader and as Director of the Research & Development Department, respectively, they occupy themselves with the development of formulas, quality control and certification on a daily basis.
Extensive documentation obligation
When a cosmetic is to be brought onto the market, in line with the EU Cosmetic Regulation a production information file (PID) has to be administered. The document is proof that the cosmetic product is safe for human health when used in a foreseeable manner. The Chemical and Safety Officer Sivanathan is responsible for compiling the file at KHK: “The PID contains information on the individual raw materials, including details about the suppliers, safety sheets and analysis certificates. Among other things we control the melting and boiling points as well as the refractive index of the raw materials in our laboratory. If the data is alright, it is a good indication for high product quality. The PID also contains a description of the cosmetic item including its ingredients and production method. Where applicable evidence of the declared effects of the product have to be provided as well as details of animal testing.” Whereas cosmetic animal testing in countries like China are prescribed by law, the sale of cosmetics tested on animals has been banned in the EU since March 11, 2013. The centrepiece of the production information file is the safety report. “The cosmetic regulation defines precisely which ingredients in which combination and concentration are allowed,” explained Sivanathan. “The safety report contains a complete analysis of the product, i.e. data on the quantitative and qualitative composition, on its physical and chemical characteristics as well as the microbiological quality of the cosmetic product. We carry out tests in order to ensure the durability and stability under extreme conditions. To this end, the formulas are stored in a special temperature cabinet for several months and exposed to extreme heat and sub-zero temperatures.”
The document additionally includes information on the primary packaging which has to be suitable for the respective contents. Sivanathan: “Some raw materials in the finished product are not compatible with the packaging. There could be an interaction. If we want to implement new packaging material we have a migration test carried out externally.” The definition of the packaging layout is also part of the PID. In addition to the ingredients, sell-by date and batch number, the socalled responsible person is listed on the label. Haverkamp: “As a rule we act as the responsible person with all the related laws and obligations. The supplement ‘for’ or ‘produced for’ gives us the opportunity to additional name the promotional products distributor or the respective end customer.” The obligations of the responsible person include registering the cosmetic with the European Cosmetic Products Notification Portal (CPNP) before introducing it onto the market. “The initial registration is very time-consuming. However, since we often work with our basic recipe Planty for promotional products orders, we don’t have to newly register each filling completely,” explained Haverkamp.
A detailed description of the production methods as well as an explanation regarding the observance of the so-called good manufacturing practice are also found in the product information file. Haverkamp: “We are certified annually by Pfeiffer Consulting according to the DIN EN ISO 22716. The audit encompasses checking the production rooms, systems and procedures – from the storage of the raw materials, to bulk production and the filling and packaging of our lipcare products, through to their dispatch. Furthermore, cleaning measures and personal hygiene are also examined carefully.” The guidelines for quality assurance are laid down in the GMP handbook. “Control documents accompany the entire production and are signed off step by step by the employees,” stated Haverkamp. “In this way, we guarantee the complete traceability of each work step during the entire production process.” After the bulk production and filling the sticks, retention samples are taken. Hourly organoleptic in-process checks are also carried out for the stick production. This involves the employees checking the lipcare mass in terms of its colour, odour and consistency, weighing the sticks and checking the temperature settings of the machines. Since the sleeves are attached by hand, this work step is also accompanied by taking a critical look at the care stick and layout. Furthermore, KHK voluntarily has a recipe, declaration and labelling test carried out by the Fresenius Institute, which the company passes on to its customers if required.
“Production complying with the cosmetic regulations and good manufacturing practice is prescribed by law. In addition, we are certified according to the quality management norm ISO 9001:2015 and can produce in compliance with the provisions of the vegan, halal or Natrue seal,” reported Haverkamp. In the case of the vegan flower of the English Organisation Vegan Society, the priority lies on the fact that the cosmetic doesn’t contain any animal elements and side products as well as it being produced without the use of animal materials. To comply with halal-conform production special audits have to prove that no additives containing pork or alcohol – including the cleaning agents used – are implemented. The Natrue seal on the other hand helps the consumers recognise true natural and organic cosmetics, because at this present point in time there is no uniform definition here. In general, it applies to cosmetic products that are as harmless as possible for humans and the environment that are made out of ecologically cultivated and chemically unchanged raw materials. “We also refrain from implementing silicone and mineral oil-based raw materials, synthetic UV filters or micro plastic – provided that alternative ingredients exist,” explained Sivanathan. “Last but not least, we have epicutaneous tests carried out by the Dermatest Institute for our standard recipes. This patch test examines the skin compatibility of the recipes we use directly on people, which corroborates that our care sticks don’t cause irritations to normal skin.” In the light of this abundance of prescribed and voluntary testing, one can simply feel safe in one’s skin.
// Jasmin Oberdorfer
Photos: Jasmin Oberdorfer, © WA Media (2); KHK (5)