The range of personal lubricants on the market is vast. And despite being especially careful about the ingredients, origins and effects of everything else we rub on our bodies, when it comes to personal lubricants it’s often a different matter. Sadly, we often give little thought to what we use in our intimate area. Yet our mucous membranes are even more sensitive than our skin. Just ask anyone with sensitive mucous membranes, who out of necessity have to look more closely at the ingredients in personal lubricants. Since we here at pjur have many years of experience in this area, and since we attach great importance to the quality of our products, this article explains what to look for when buying a personal lubricant.
Directives and regulations for personal lubricants
Personal lubricants for use with condoms are so-called medical devices that are divided into four risk classes: I, IIa, IIb and III. The classification is based on use, duration of application, anatomical position and the resulting application risk. The new European Medical Device Regulation (MDR) comes into force from May 2020 onwards. The new regulation contains more stringent requirements for manufacturers of medical devices. It replaces Directive MDD 93/42/EEC, which had previously been in effect since 1993. The new regulation is an international regulatory instrument that ensures the safety of medical devices and their medical and technical performance in the countries of the European Union. Following the introduction of the new MDR, personal lubricants will be classified as risk class IIa.
pjur started to take the necessary steps for this early on and has been a certified manufacturer of medical devices in line with the new ISO standard 13485:2016 since June 2019. pjur has therefore successively converted its lubricants portfolio to Class IIa.
Authorities in various countries
Each country has different authorities which oversee the guidelines and directives for personal lubricants used with condoms. Yet depending on the market, these controls sometimes aren’t carried out frequently enough, which is why there are still plenty of unregistered products on the market. With pjur products, you can always 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: The Food and Drug Administration oversees food, drugs and medical devices in the US. The FDA decides whether a new food or medical device is approved and can therefore be sold. The FDA differentiates between three FDA classes: class I, class II and class III. Products in class I pose a minor risk to patients and users, those in class two pose a medium risk, and those in class III pose the highest risk to those using the product compared to the other classes.
The TGA in Australia: The situation is similar in Australia. The responsible authority there is called the Australian Therapeutic Goods Administration, or TGA for short. Like the FDA, the TGA oversees medical devices in Australia. Medical devices that are not registered in the Australian Register of Therapeutic Goods (ARTG) cannot be sold on the Australian market. However, the TGA takes the European CE marking into account, making the registration process easier for products which have this marking.
As mentioned previously, manufacturers still try to circumvent these regulations. Consumers should therefore take extra steps to protect themselves by looking out for the seals that are usually found on a product or its packaging. We take a look at a few of these seals below.
Buying personal lubricants – seals to look out for
We are all probably familiar with the ‘Dermatest’ seal or the vegan flower of the Vegan Society. Seals such as these are awarded to products by independent testing organisations, signalling to consumers that these products meet specific regulations and standards. There are a vast number of seals that consumers can keep an eye out for. We have listed just a few of them below:
CE: A product that carries the CE marking meets the health and safety requirements of the European Union. Use of the CE marking demonstrates to consumers that the manufacturer is compliant with EU Directives and standards. This CE marking with a four-digit number clearly indicating the notified body indicates that the marked product is a medical device. In addition to this CE marking with a four-digit number, the marking with “MD” is also decisive in order to be classified as a medical device.
Dermatest: The ‘Original DERMATEST’ seal is used to indicate products where the manufacturers have kept their commitment to tested and approved quality. There are three different grades of the seal: 5-star guarantee / clinically tested, 3-star guarantee, and Dermatest guarantee.
The vegan flower of the Vegan Society: This seal shows consumers that products with this distinction do not contain any animal products and have not been tested on animals.
Personal lubricants are used in the most intimate areas, including internally. That’s why people will likely want to be sure that products have been adequately tested. Consumers should therefore scrutinise the manufacturers a little more closely. The seals listed here also help consumers decide whether a product is suitable for use in intimate areas.