In 2021, the National Pharmaceutical Regulatory Authority (NPRA) established regulatory guidelines for surface disinfectants to undergo voluntary registration for the first time. Now, after 3 years and multiple minor amendments to the guideline, there is a brand-new revision with major changes to include a more comprehensive testing requirements for product claims in different areas of application. Before we dive into what the changes are, if you are not familiar with this process, check out our previous blog post here.
What’s new in the NPRA surface disinfectant guidelines?
Prior to this latest revision, there has not been any changes to the efficacy testing requirements in 3 years, mainly editorial amendments for clarity on the registration process. Therefore, this 3rd revision is a big deal for manufacturers either planning to register or with surface disinfectants already registered. In this, we now observe NPRA further incorporating the European EN 14885 guidelines into their requirements with more comprehensive testing for product claims to suit their respective application areas ensuring effective products being utilized as per recommended and claimed.
Take a look at the summary table below for the new requirements. Feel free to also click through the links to read more about each test method.
| AREA OF APPLICATION | MINIMUM SPECTRUM OF ACTIVITY | EFFICACY TESTING REQUIRED | |
| 2023 version | 2024 version | ||
| Healthcare institution | Bactericidal & Yeasticidal | EN 13697 (without mechanical action; under claimed conditions) or EN 16615 (with mechanical action; under claimed conditions) |
EN 17387 (without mechanical action; under dirty condition) or EN 16615 (with mechanical action; under dirty condition) |
| Virucidal | EN 14476 (under claimed conditions) |
EN 14476 (under dirty condition) EN 16777 (without mechanical action; under dirty condition) |
|
| Veterinary | Bactericidal | EN 1656 | EN 1656 |
| Yeasticidal | EN 1657 | EN 1657 | |
| Virucidal | Not specified | EN 14675 (optional if claimed) |
|
| Related to food preparation except for hospital use | Bactericidal & Yeasticidal | EN 1276 & EN 1650 | EN 13697 or EN 1276 & EN 1650 |
| Domestic | |||
| Institution | |||
| *All efficacy tests to be done in ISO 17025 accredited laboratories to conduct EN test. | |||
The main differences are in the requirements of disinfectants for use in healthcare institutions, where we see;
One, the change from EN 13697 to EN 17387, which is the newest published standard method for disinfectants applied without mechanical action in the medical area. Despite the test method being similar, there are major differences, especially so in the test conditions and passing criteria, between these two standards as laid out in our previous blog post for your further information.
Two, the mandatory requirement of virucidal activity for all products along with implementation of EN 16777 in addition to EN 14476 for products applied without mechanical action. Now, I did say we see incorporations of EN 14885 by NPRA into their guideline. In EN 14885, necessary tests are required based on the product claims (eg. if the product does not claim to have virucidal activity, tests for this activity are not required). However, very unlike EN 14885, virucidal activity is mandatory for NPRA registration. Our Ministry of Health have deemed viral infections a major concern in healthcare institutions and therefore made it essential for disinfectants to have this activity if it is to be used in this area regardless of the initial intended claims.
Three, the mandatory need for tests done under dirty condition. Similar to our second point, our Ministry of Health has also figured high levels of soiling are commonly found on surfaces in healthcare institutions and therefore, is critical for products to be effective under this condition.
Other than efficacy requirements, active ingredient data along with stability data is also required to be submitted upon registration.
What should you do next? How can TECOLAB help you?
With this new information, it is important to check on the tests you have done previously. This is especially crucial for manufacturers with products for the healthcare institution considering the addition of standards and mandatory testing under dirty condition, leading to retesting of your products necessary for registration (or renewal).
Besides EN efficacy tests, other established equivalent standards by ASTM, AOAC, TGA or others may also be accepted by NPRA as long as they fulfil the above activity spectrum. If your product has been tested previously according to other methods but unsure if they are suitable, feel free to drop us an email, we will review your reports to see if they comply to NPRA’s requirements and if not, advise you on the best route to take.
While registration of surface disinfectants with NPRA is currently still voluntary, meaning you can market/import your products freely without it, NPRA may decide to make it compulsory in the future. Why not take this chance to get ahead of the market while the registration is free? Our experts are always readily available to assist you in obtaining all the necessary testing requirements for you to register your surface disinfectant with NPRA. Get in touch with us here and leave the testing planning to us!
This blog was written solely based on our team’s interpretation of the NPRA guideline and communication with NPRA.
Reference:
1. NPRA – Guidelines for the Registration of Surface Disinfectant, Revision 4.0