The EU Cosmetics Regulation 2009 highlights the importance and positions of manufacturers and natural or legal responsible persons in the cosmetics process.
Korean brands need to be aware of these differentiating positions within the cosmetics framework. Article 4 of the regulations, for example, sets out the 'responsible person' and states that only a cosmetics product for which a natural or legal responsible person has been designed within the EU community can be placed on the market.
In addition, Article 11 focuses on conformity by stating that a responsible person has to have a manufacturer to help prepare products that meet the safety and compliance within the law. Only one product file, for example, can be completed and approved by the responsible person in order to access the European market.
While there are other crucial players in between the manufacturer and responsible person, the responsible person must have access to all details relating to cosmetics documentation and safety tests. It is important to note that there can't be any information that is not disclosed.
While confidentiality can be a challenge, parties can sign non-disclosure agreements (NDAs) to provide reassurance while enabling full disclosure relating to all relevant details.
The Product Information file contains information relating to the formula; raw material specifications; finished product specifications; method of manufacture; packaging specification (purity, food grade certification); key quality assurance points; GMP certification and declaration, animal testing; be aware of companies actively working in this area; and labels (include proof of claim - training and fulfillment of long requirements) and safety assessment report.
Before entering a new market, and with a particular focus on Korean and APAC brands looking to move into Europe, there are several tests that brands should conduct and consider:
- Stability test. This evaluates how a product maintains characteristics over time.
- Compatibility test. This explores the compatibility between primary packaging and products. Both of these tests are measured at room temperature, low temperature and high temperature.
- Challenge test. This particular test looks at product’s “auto-protection” capabilities from the micro-growth efficient functionality of the preservative system.
- Patch tests. This is an additional test, which can determine whether there is a chance of a reaction.
The next step is to think about partnering with a laboratory, where Good Lab Practices (GLP) must be considered. Timeframes that vary with protocols and reports that look at lab procedures are also important.
When considering partnerships, the importer who moves goods from outside the EU is the responsible person. Then there is the producer and the distributor, who only moves goods inside the EU and is not the responsible person. This distinction is important to understand the market requirements.
The second part of this article, which will explore challenges and key questions to ask when looking to move cosmetics items into Europe, will be published on Tuesday 10th July 2018.