There are plenty of different personal lubricants on the market. Yet very few people take the trouble to look a little more closely at the individual products and choose a high-quality lubricant. Sadly, little thought is given to the ingredients used or whether a product has been tested according to specific regulations. And that’s despite the fact that mucous membranes are significantly more sensitive than normal skin. Anyone with sensitive mucous membranes will know how important it is to look out for these things – no matter what the product is. Here at pjur, we attach great importance to the quality of our products and have many years of experience. Which is why this post takes a closer look at what to look for when buying a personal lubricant.
What directives and regulations are there for personal lubricants?
Personal lubricants are medical devices. They are classified as such based on the risk to the human body. The classifications range from no risk through to high risk and a potential hazard. The following four classes exist: Class I – Low risk, Class IIa – Medium risk, Class IIb – Medium to high risk, Class III – High risk. The classification is based on a number of factors including where a device is used, the duration of application, anatomical position and the resulting application risk. Medical devices are assigned one of the four risk categories based on these criteria. pjur personal lubricants are regarded as invasive medical devices as they can be used to relieve the symptoms of vaginal dryness. They enter the body and have therefore been classified as Class IIb medical devices since May 2021 in accordance with the Medical Device Regulation (MDR). pjur has been a certified manufacturer of medical devices since 2014 and operates a quality management system in line with the ISO standard 13485:2016.
All of our personal lubricants are Class IIb medical devices and are safe to use with latex condoms.
What authorities are there?
Different authorities in each country have the responsibility of overseeing the directives for personal lubricants used with condoms. Yet depending on the market, these controls sometimes aren’t carried out frequently enough, which is why unregistered products can still be found on the market. With pjur products, you can be confident that they are registered with all the authorities below, as well as many others, meaning they comply with all directives and standards:
- The FDA in the US: FDA is the acronym for the Food and Drug Administration – an authority which monitors food, drugs and medical devices in the US. Only once a product has been approved by the FDA can the food or medical device be sold in the US. The FDA sorts products into three different classes: class I, denoting products which pose a minor threat to patients and users; class II, denoting products to which the FDA attributes medium risk; and class III, for products which pose the highest risk to patients and users compared to the other classes.
- The TGA in Australia: In Australia, TGA stands for the Australian Therapeutic Goods Administration. A similar authority to the FDA in America, it too oversees medical devices to ensure that they are suitable for distribution in the Australian market. Products deemed suitable for sale are entered in the Australian Register of Therapeutic Goods (ARTG) and can be sold. Unlike in the US, the TGA takes the European CE marking into account, which usually simplifies the registration process.
As mentioned previously, consumers should take precautions to protect themselves since some manufacturers still manage to circumvent these directives and requirements. Seals can also reveal something about the quality of a personal lubricant and whether a manufacturer attaches any value to the ingredients and manufacturing methods.
Important seals found on personal lubricants
You see them time and again on products and their packaging: seals from independent testing organisations, such as the vegan flower or the ‘Dermatest’ seal. Only products which meet the standards stipulated by the organisation in question are awarded the vegan flower or the ‘Dermatest’ seal. If it is important to you which products you use, you should keep an eye out for labels like these. We have put together a list of a few of these seals for you below:
The CE marking: The European Union uses this CE marking to label products that meet the health and safety requirements stipulated by the EU. In addition, manufacturers must therefore observe EU directives and standards in their production. All pjur lubricants that can be used with condoms have this symbol on their packaging.
The Dermatest seal: The ‘Original DERMATEST’ seal is used to indicate products with tested and approved quality. Their manufacturers maintain certain quality standards. To give consumers better guidance, there are three different seal grades: 5-star guarantee / clinically tested, 3-star guarantee, and Dermatest guarantee. All pjur lubricants have the Dermatest seal.
The vegan flower: This seal is awarded by the Vegan Society and is intended to show consumers which products are free from animal products and have not been tested on animals.
The ECARF seal of quality: This seal is one that allergy sufferers in particular should look out for, since it indicates that using a product with this seal is highly unlikely to result in an allergic reaction. The ECARF seal of quality is used for both products and services. These products and services are studied and tested for specific threshold values and exclusion criteria. The ECARF seal is known in more than 30 countries and tells allergy sufferers – and all other users – whether a product is hypoallergenic.
The Ökotest seal: The magazine ‘Ökotest’ tests all forms of products, rating them either ‘very good’, ‘good’, etc. This involves looking at whether a product is free from harmful substances. The rating a product receives gives an indication of whether or not it contains harmful substances and, if so, to what extent.
Personal lubricants are used in sensitive areas of the body, including internally – making it all the more important to be mindful of quality. That’s why it is vital that all consumers scrutinise a product’s manufacturer – and the product itself – a little more closely.